Clinical trial • Phase I/II • Neurology

CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B for Upper limb spasticity (post-stroke) | Upper limb spasticity (post-traumatic brain injury)

Phase I/II trial of CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B for Upper limb spasticity (post-stroke) | Upper limb spasticity (post-traumatic brain i…

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Upper limb spasticity (post-stroke) | Upper limb spasticity (post-traumatic brain injury)
Trial Stage
Phase I/II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
22-04-2024
First CTIS Authorization Date
28-05-2024

Trial design

Randomised, open-label, dysport (botulinum toxin type a - haemagglutinin complex) — dysport 500 unites speywood; route: intramuscular; dose note: eligibility text notes participants should be eligible to receive a total recommended dose 1000 u dysport in the upper limb when applicable.-controlled, adaptive Phase I/II trial in Austria, Bulgaria, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Dysport (botulinum toxin type A - haemagglutinin complex) — DYSPORT 500 UNITES SPEYWOOD; route: intramuscular; dose note: eligibility text notes participants should be eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
Adaptive
True, dose-escalation and dose-finding design: Stage 1 assesses safety and tolerability of increasing doses of a single IPN10200 treatment vs Dysport and placebo and selects two dose levels for Stage 2; Stage 2 selects lowest safe and effective dose for further investigation; sentinel participants and staged dose escalation described.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
85
Trial Duration For Participant
270

Eligibility

Recruits 85 Vulnerable population flag is selected. Participants must be capable of giving signed informed consent ("Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol."). Consent is obtained from the participant; no assent procedures for minors are provided (study enrolment restricted to adults). Multiple language ICF/SIS documents are provided for participant information..

Pregnancy Exclusion
Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study and for the duration of the study.
Vulnerable Population
Vulnerable population flag is selected. Participants must be capable of giving signed informed consent ("Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol."). Consent is obtained from the participant; no assent procedures for minors are provided (study enrolment restricted to adults). Multiple language ICF/SIS documents are provided for participant information.

Inclusion criteria

  • {"criterion_text":"- Participant must be 18 to 70 years of age inclusive (except for dose escalation must be 18 to 65 years of age) at the time of signing the informed consent.\n- In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgement prior to randomisation\n- Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study. • Female participants: o A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR  Is a WOCBP and using an acceptable contraceptive method during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)  If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.\n- Has spastic hemiparesis following stroke or TBI\n- Is at least 6 months post-stroke or TBI\n- Has never received BoNT or if previously treated, should have received their last injection of any commercialised BoNT-A or B at least 4 months prior to study Baseline\n- Has a MAS score ≥2 in the PTMG to be injected\n- Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable\n- Has angle of spasticity ≥5° in the PTMG to be injected\n- Has the angle of arrest as measured by the Tardieu scale (XV1) in the muscle groups to be injected as follows: • XV1 ≥160° for finger flexors • XV1 ≥90° for wrist flexors • XV1 ≥160° for elbow flexors\n- Stage 1 and 2: Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study. Stage 3: Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 3 months preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study."}

Exclusion criteria

  • {"criterion_text":"- Any medical condition (including, but not limited to: severe dysphagia or airway disease, severe impairment of ability to walk (e.g. wheelchair-bound) and/or living in long-term care facilities due to loss of autonomy) that may increase, in the opinion of the investigator, the likelihood of adverse events related to BoNT treatment.\n- A history of drug or alcohol abuse\n- Male participants who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.\n- Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).\n- Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.\n- Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant’s participation in the study.\n- Likely treatment with any serotype of BoNT for any condition during the study.\n- Undergone previous surgery to treat spasticity in the affected upper limb.\n- Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated more than 30 days prior to Baseline and ongoing, the therapy regimen should be maintained at the same frequency and intensity throughout the study if possible or at least up to 3-months post-injection)\n- Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.\n- Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study.\n- Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non-depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within 30 days prior to Baseline.\n- Use of concomitant therapy which, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders.\n- Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening.\n- Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.\n- Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies, cancer cachexia, sarcopenia or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.\n- Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study and for the duration of the study.\n- Inability to understand protocol procedures and requirements\n- Infection at the injection site(s)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants with treatment emergent adverse events (TEAEs).","definition_or_measurement_approach":"Measured as the percentage/proportion of participants experiencing TEAEs during the study period (safety endpoint)."}
  • {"endpoint_text":"- Percentage of participants with adverse events of special interest (AESI).","definition_or_measurement_approach":"Measured as the percentage/proportion of participants experiencing predefined AESIs during the study period."}
  • {"endpoint_text":"- Change from baseline in vital sign parameter (blood pressure)","definition_or_measurement_approach":"Change from baseline to post-treatment assessments in blood pressure measurements (absolute or relative change as recorded at scheduled visits)."}
  • {"endpoint_text":"- Change from baseline in vital sign parameter (Heart rate)","definition_or_measurement_approach":"Change from baseline to post-treatment assessments in heart rate measurements at scheduled visits."}
  • {"endpoint_text":"- Change from baseline in clinical laboratory test results.","definition_or_measurement_approach":"Change from baseline in standard clinical laboratory parameters (hematology, biochemistry) measured at scheduled visits."}
  • {"endpoint_text":"- Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)","definition_or_measurement_approach":"Assessment of immunogenicity: detection of binding and neutralising antibodies against IPN10200 and BoNT-A in blood samples."}
  • {"endpoint_text":"- Change from baseline in physical examination findings","definition_or_measurement_approach":"Change from baseline in findings on physical examination recorded at scheduled visits."}
  • {"endpoint_text":"- Response to treatment measured by at least one grade reduction in Modified Ashworth Scale (MAS) score in the primary targeted muscle group (PTMG).","definition_or_measurement_approach":"Responder defined as at least one-grade reduction in MAS score in PTMG compared with baseline."}

Secondary endpoints

  • {"endpoint_text":"- Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)","definition_or_measurement_approach":"Change from baseline in MAS score in PTMG assessed at each post-treatment visit."}
  • {"endpoint_text":"- Change from Baseline to post-treatment Day 29 in MAS score in the PTMG","definition_or_measurement_approach":"Change in MAS score in PTMG from baseline to Day 29 post-treatment."}
  • {"endpoint_text":"- Change from Baseline in MAS score in all injected muscle Groups","definition_or_measurement_approach":"Change from baseline in MAS score across all injected muscle groups measured at scheduled visits."}
  • {"endpoint_text":"- PD characteristics of IPN10200 in the PTMG: o Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score). o Peak of effect - maximal decrease in the MAS score from Baseline. o Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline). o Duration of effect - duration between time to onset and last timepoint with a response to Treatment","definition_or_measurement_approach":"Pharmacodynamic endpoints: time to onset (first visit showing ≥1-grade MAS reduction), peak effect (maximum MAS decrease), time to peak (timepoint of maximal MAS decrease), and duration (interval between onset and last observed response)."}
  • {"endpoint_text":"- Response to treatment as measured by at least one grade reduction in MAS score in the PTMG from Baseline","definition_or_measurement_approach":"Responder = ≥1-grade reduction in MAS in PTMG from baseline at assessed visits."}
  • {"endpoint_text":"- Response to treatment as measured by at least one grade reduction in MAS score in all injected muscle groups","definition_or_measurement_approach":"Responder = ≥1-grade reduction in MAS in any injected muscle group from baseline."}
  • {"endpoint_text":"- Physician’s Global Assessment (PGA) score of overall treatment response","definition_or_measurement_approach":"Investigator global assessment score of overall response recorded at visits."}
  • {"endpoint_text":"- Patient Global Impression of Change in the Spastic Clinical Pattern using specific scale (PGI-c)","definition_or_measurement_approach":"Participant-reported global impression of change in spastic clinical pattern using PGI-c scale."}
  • {"endpoint_text":"- Change from Baseline in the Disability Assessment Scale (DAS)","definition_or_measurement_approach":"Change from baseline in DAS scores measured at scheduled visits."}
  • {"endpoint_text":"- Reduction of pain in the shoulder using the Numeric Rating Scale","definition_or_measurement_approach":"Change from baseline in shoulder pain as measured by the Numeric Rating Scale (NRS)."}
  • {"endpoint_text":"- Change from Baseline in the Tardieu Scale (TS) in the PTMG","definition_or_measurement_approach":"Change from baseline in Tardieu Scale measurements for PTMG at scheduled visits."}
  • {"endpoint_text":"- Change from Baseline in the active range of motion (AROM) in all injected muscle groups including the PTMG","definition_or_measurement_approach":"Change from baseline in AROM measurements for all injected muscle groups (including PTMG) at scheduled visits."}
  • {"endpoint_text":"- Percentage of participants with TEAEs.","definition_or_measurement_approach":"Proportion of participants experiencing TEAEs (safety monitoring)."}
  • {"endpoint_text":"- Percentage of participants with AESIs.","definition_or_measurement_approach":"Proportion of participants experiencing AESIs (safety monitoring)."}
  • {"endpoint_text":"- Percentage of participants with clinically significant changes from baseline in vital signs","definition_or_measurement_approach":"Proportion of participants with clinically significant vital sign changes from baseline (predefined thresholds)."}
  • {"endpoint_text":"- Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings","definition_or_measurement_approach":"Proportion with clinically significant ECG changes from baseline (12-lead ECG assessments)."}
  • {"endpoint_text":"- Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters","definition_or_measurement_approach":"Proportion with clinically significant laboratory parameter changes from baseline (predefined criteria)."}
  • {"endpoint_text":"- Percentage of participants with Binding antibodies of IPN10200 and BoNT-A","definition_or_measurement_approach":"Proportion of participants with binding antibodies detected against IPN10200 and BoNT-A."}
  • {"endpoint_text":"- Percentage of participants with neutralising antibodies of IPN10200 and BoNT-A","definition_or_measurement_approach":"Proportion of participants with neutralising antibodies detected against IPN10200 and BoNT-A."}
  • {"endpoint_text":"- Percentage of participants with clinically significant change from baseline in physical examination","definition_or_measurement_approach":"Proportion with clinically significant changes on physical exam from baseline as judged by predefined criteria."}
  • {"endpoint_text":"- Change from Baseline in MAS score in the PTMG.","definition_or_measurement_approach":"Change from baseline in MAS in PTMG measured at visits."}
  • {"endpoint_text":"- Change from Baseline in MAS score in all injected muscle groups.","definition_or_measurement_approach":"Change from baseline in MAS across all injected muscle groups at visits."}
  • {"endpoint_text":"- Change from Baseline in MAS score in the PTMG","definition_or_measurement_approach":"Change from baseline in MAS score in PTMG (repeat listing across timepoints/visits)."}
  • {"endpoint_text":"- Change from Baseline in MAS score in all injected muscle groups.","definition_or_measurement_approach":"Change from baseline in MAS across all injected muscles (repeat listing across timepoints/visits)."}
  • {"endpoint_text":"- Response to treatment as measured by at least one grade reduction in MAS score in the PTMG","definition_or_measurement_approach":"Responder = ≥1-grade MAS reduction in PTMG from baseline (repeated timepoint assessments)."}
  • {"endpoint_text":"- Response to treatment as measured by at least one grade reduction in MAS score in all injected muscle groups","definition_or_measurement_approach":"Responder = ≥1-grade MAS reduction in any injected muscle group from baseline (repeated timepoint assessments)."}
  • {"endpoint_text":"- Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).","definition_or_measurement_approach":"Time (days) from dosing to first observed response (≥1-grade MAS reduction)."}
  • {"endpoint_text":"- Peak of effect - maximal decrease in the MAS score from Baseline.","definition_or_measurement_approach":"Maximum observed decrease in MAS relative to baseline across follow-up."}
  • {"endpoint_text":"- Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline).","definition_or_measurement_approach":"Time from dosing to the visit with maximal MAS decrease relative to baseline."}
  • {"endpoint_text":"- Duration of effect - duration between time to onset and last timepoint with a response to treatment.","definition_or_measurement_approach":"Interval between onset of response and last visit showing response (duration in days/weeks as recorded)."}
  • {"endpoint_text":"- PGA score of overall treatment response at all post treatment visits","definition_or_measurement_approach":"Investigator PGA scores at each post-treatment visit."}
  • {"endpoint_text":"- PGIC at all post-treatment visits.","definition_or_measurement_approach":"Participant PGIC scores collected at all post-treatment visits."}
  • {"endpoint_text":"- Change from Baseline to all post-treatment visits in the DAS.","definition_or_measurement_approach":"Change from baseline in Disability Assessment Scale at scheduled visits."}
  • {"endpoint_text":"- Change from baseline to all post-treatment visits in NRS pain in the shoulder.","definition_or_measurement_approach":"Change from baseline in shoulder pain NRS at scheduled visits."}
  • {"endpoint_text":"- Change from Baseline in the Tardieu Scale in shoulder adductors","definition_or_measurement_approach":"Change from baseline in Tardieu Scale for shoulder adductors at visits."}
  • {"endpoint_text":"- Change from Baseline in the Tardieu Scale in elbow flexors","definition_or_measurement_approach":"Change from baseline in Tardieu Scale for elbow flexors at visits."}
  • {"endpoint_text":"- Change from Baseline in the Tardieu Scale in wrist flexors (when applicable)","definition_or_measurement_approach":"Change from baseline in Tardieu Scale for wrist flexors if applicable."}
  • {"endpoint_text":"- Change from Baseline in the Tardieu Scale in finger flexors (when applicable) at all timepoints","definition_or_measurement_approach":"Change from baseline in Tardieu Scale for finger flexors when applicable at all assessed timepoints."}
  • {"endpoint_text":"- Change from Baseline to all post-treatment visits in AROM in all injected muscle groups.","definition_or_measurement_approach":"Change from baseline in active range of motion for all injected muscle groups measured at each post-treatment visit."}

Recruitment

Planned Sample Size
85
Recruitment Window Months
96
Consent Approach
Informed consent obtained from each participant (must be capable of giving signed informed consent). Multiple subject information and informed consent form documents exist (languages and country-specific ICFs provided: e.g., DE, ES, PL, HU, BG, CZ and English versions among others). No assent for minors mentioned (study restricted to adults).

Geography

Total Number Of Sites
45
Total Number Of Participants
298

Austria

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
594
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Konvent Der Barmherzigen Brueder
Department Name
Department of Neurology I
Contact Person Name
Rudolf Sommer
Contact Person Email
rudolf.sommer@bblinz.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Neurology
Contact Person Name
Thomas Mitterling
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Neurology
Contact Person Name
Sylvia Boesch
Contact Person Email
sylvia.boesch@i-med.ac.at

Bulgaria

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
560
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Medical Center Medica Plus Ltd.
Contact Person Name
Ivan Ivanov
Contact Person Email
ivanov@mcmedicaplus.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Krasimir Genov
Contact Person Email
kr_genov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases
Contact Person Name
Ivan Milanov
Contact Person Email
milanovivan@yahoo.com
Site Name
Medical Center Rusemed EOOD
Contact Person Name
Aleksandar Bosilkov
Contact Person Email
rusemed@gmail.com
Site Name
Medical Center Academica 2008 EOOD
Contact Person Name
Plamen Tsvetanov
Contact Person Email
tsvetanovmd@mail.bg
Site Name
Medical Center Medica 2005 EOOD
Contact Person Name
Valentina Ignatova-Valkova
Contact Person Email
valyaig@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
622
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologická klinika
Contact Person Name
Edvard Ehler
Contact Person Email
edvard.ehler@nempk.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologická klinika
Contact Person Name
Robert Jech
Contact Person Email
robert.jech@vfn.cz
Site Name
Hospital Jihlava
Department Name
Neurologické oddělení
Contact Person Name
Ondřej Škoda
Contact Person Email
skodao@nemji.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurologická klinika
Contact Person Name
Michal Bar
Contact Person Email
michal.bar@fno.cz

Germany

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
574
Number Of Sites
3
Number Of Participants
43

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Clinic and Polyclinic of Neurology
Contact Person Name
Mathias Gelderblom
Contact Person Email
m.gelderblom@uke.de
Site Name
Gemeinnuetzige Gesellschaft der Franziskanerinnen zu Olpe mbH (place of conduct listed as GFO Kliniken Troisdorf)
Department Name
St. Johannes Sieglar; Place of conduct: GFO Kliniken, Wilhelm-Busch-Strasse 9, 53844 Troisdorf
Contact Person Name
Sebastian Alexander Paus
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Department for Parkinson's disease, sleep and movement disorders (1st floor)
Contact Person Name
Pawel Tacik
Contact Person Email
Pawel.Tacik@ukbonn.de

Hungary

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
561
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Szent Damjan Goeroegkatolikus Korhaz
Department Name
Department of Neurology and Stroke
Contact Person Name
Marina Czurko
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Department of Neurology
Contact Person Name
Attila Valikovics
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Department of Neurology
Contact Person Name
Attila Csanyi
Contact Person Email
csanyia@petz.gyor.hu
Site Name
Semmelweis University
Department Name
Rehabilitation Clinic, Rehabilitation Department of Brain Injuries
Contact Person Name
Zoltan Denes
Contact Person Email
denes.zoltan.dr@rehabint.hu
Site Name
University Of Debrecen
Department Name
Department of Medical Rehabilitation and Physical Medicine
Contact Person Name
Zoltan Jenei
Contact Person Email
jenei.zoltan@med.unideb.hu

Poland

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
555
Number Of Sites
9
Number Of Participants
108

Sites

Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Szpital Św. Wojciecha, Oddział Neurologiczny
Contact Person Name
Jarosław Sławek
Contact Person Email
jaroslawek@gumed.edu.pl
Site Name
Ilkowski I Partnerzy sp.p. Lekarzy
Department Name
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Contact Person Name
Jan Ilkowski
Contact Person Email
jan.ilkowski@neurokard.pl
Site Name
Specjalistyczne Gabinety Sp. z o.o.
Department Name
Specjalistyczne Gabinety
Contact Person Name
Marek Banach
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Department Name
Centrum Neurologii Klinicznej
Contact Person Name
Monika Rudzińska-Bar
Site Name
Linden Sp. z o.o. sp.k.
Department Name
Centrum Medyczne Linden
Contact Person Name
Małgorzata Krawczyk
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Department Name
Poradnia Neurologiczna
Contact Person Name
Magdalena Boczarska-Jedynak
Contact Person Email
m.boczarskajedynak@gmail.com
Site Name
Szpital Specjalistyczny Ducha Swietego W Sandomierzu
Department Name
Klinika Neurologii - Oddział Neurologiczny
Contact Person Name
Piotr Sobolewski
Contact Person Email
piotrsobolewski@poczta.onet.pl
Site Name
Neuro-Medic Sp. z o.o.
Department Name
Poradnia Wielospecjalistyczna
Contact Person Name
Janusz Zbrojkiewicz
Contact Person Email
jzbrojkiewicz@op.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
Penta Hospitals Przychodnie, Wrocław Wejherowska
Contact Person Name
Monika Susz-Kołodyńska
Contact Person Email
jasuszka@poczta.onet.pl

Spain

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
552
Number Of Sites
7
Number Of Participants
26

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurorehabilitation and Brain Injury
Contact Person Name
Susana Rodriguez Gonzales
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Physical Medicine and Rehabilitation. Hospital Meixoeiro
Contact Person Name
Francisco Javier Juan Garcia
Site Name
Area Sanitaria Da Coruna E Cee
Department Name
Physical Medicine and Rehabilitation. Hospital Maritimo de Oza
Contact Person Name
Jacobo Formigo Couceiro
Site Name
Universidade De Santiago De Compostela
Department Name
Physical Medicine and Rehabilitation. Complexo Hospitalario Universitario de Santiago
Contact Person Name
Jesus Figueroa Rodriguez
Site Name
Hospital Universitario De La Princesa
Department Name
Physical Medicine and Rehabilitation
Contact Person Name
Aranzazu Vazquez Doce
Contact Person Email
vazquezdoce@hotmail.com
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Rehabilitation Department
Contact Person Name
Carlos Cordero Garcia
Contact Person Email
ccordero.rhb@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Rehabilitation Department
Contact Person Name
Manuel Rodriguez Pinero Duran

Italy

Earliest CTIS Part Ii Submission Date
01-12-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
17
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Movement disorders Unit- Neuroscience Area
Contact Person Name
Anna Rita Bentivoglio
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Neurosciences, Biomedicine and Movement Science
Contact Person Name
Alessandro Picelli
Contact Person Email
alessandro.picelli@univr.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Multiple Sclerosis Unit- UOSD Multiple Sclerosis
Contact Person Name
Marcello Moccia
Contact Person Email
marcello.moccia@unina.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.C. Neurology
Contact Person Name
Salvatore Caratozzolo
Contact Person Email
salvatore.carozzolo@nana.com

Portugal

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
109
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
Physical Medicine and Rehabilitation
Contact Person Name
Andre Cruz
Contact Person Email
andre.cruz@ulsam.min-saude.pt
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Physical Medicine and Rehabilitation
Contact Person Name
Maria Joao Azevedo
Contact Person Email
3247@ulsaave.min-saude.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Neurology
Contact Person Name
Ana Claudia Ribeiro
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Neurology
Contact Person Name
Sandra Moreira
Contact Person Email
investigacao@ulsm.min-saude.pt

France

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
6
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Centre Hospitalier General De Bastia
Department Name
Physical Medicine and Functional Rehabilitation
Contact Person Name
Jean-Michel Gracies
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Physical Medicine and Functional Rehabilitation
Contact Person Name
Olivier Remy-Neris
Contact Person Email
remyneris@univ-brest.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Physical Medicine and Functional Rehabilitation
Contact Person Name
Bertrand Glize
Contact Person Email
bertrand.glize@chu-bordeaux.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Physical Medicine and Functional Rehabilitation
Contact Person Name
Djamel Ben Smail
Contact Person Email
djamel.bensmail@aphp.fr

Sponsor

Primary sponsor

Full Name
Ipsen Innovation
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Psi Cro AG
Responsibilities
Multiple operational responsibilities (codes listed: 1;10;11;12;15 (vendor management, medical monitoring, DSMB);2;5;6;8;9)
Name
Medidata Solutions Inc.
Responsibilities
Study data platform / related services (duty code 7)
Name
Cognizant Worldwide Limited
Responsibilities
PV case processing

Third parties

  • {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"1;10;11;12;15 (vendor management, medical monitoring, DSMB);2;5;6;8;9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"15 (Patient travel and reimbursement management)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Cognizant Worldwide Limited","duties_or_roles":"15 (PV case processing)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IPN10200
Active Substance
CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B
Modality
Peptide/protein/enzyme
Routes Of Administration
Intramuscular use
Route
Intramuscular
Authorisation Status
Investigational
Frequency
Single injection (per dosing session as defined by protocol)
Investigational Product Name
DYSPORT 500 UNITES SPEYWOOD (comparator)
Active Substance
BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
Modality
Peptide/protein/enzyme
Routes Of Administration
Intramuscular use
Route
Intramuscular
Authorisation Status
Authorised (commercial product DYSPORT listed with marketing authorisation details)
Frequency
Single injection (per protocol dosing session)
Maximum Dose
Eligibility notes a total recommended dose of 1000 U Dysport in the upper limb when applicable
Investigational Product Name
IPN10200 placebo
Modality
Other
Frequency
Single injection (placebo comparator)

Related trials

Other published trials that may interest you.