Clinical trial • Phase II • Musculoskeletal
CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B for Cervical dystonia
Phase II trial of CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B for Cervical dystonia.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Cervical dystonia
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 12-05-2025
Trial design
Randomised, placebo of ipn10200 (placebo comparator). dose and schedule not specified in the ctis record.-controlled Phase II trial across 32 sites in France, Poland, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo of IPN10200 (placebo comparator). Dose and schedule not specified in the CTIS record.
- Target Sample Size
- 94
- Trial Duration For Participant
- 252
Eligibility
Recruits 94 No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is from adult participants; no assent arrangements are indicated..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is from adult participants; no assent arrangements are indicated.
Inclusion criteria
- {"criterion_text":"- A clinical diagnosis of isolated Cervical Dystonia (CD) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder areas with at least moderate severity at Screening and Baseline (Day 1) defined as: • (a) Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)- Total score ≥20 • (b) TWSTRS-Severity subscale score ≥15 • (c) TWSTRS-Disability subscale score ≥3 • (d) TWSTRS-Pain subscale score ≥ 1\n- Treatment naïve or non-naïve to BoNT therapy for CD"}
Exclusion criteria
- {"criterion_text":"- Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as: • (a) Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.\n- Predominant anterocollis.\n- Predominant retrocollis.\n- Traumatic torticollis or tardive torticollis.\n- Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. [Time frame: at week 4]","definition_or_measurement_approach":"Change from baseline in the TWSTRS total score measured at Week 4."}
Secondary endpoints
- {"endpoint_text":"- Change from Baseline in the TWSTRS total score at all other scheduled timepoints post injection until Week 36. [Time Frame: At all timepoints post injection until Week 36.]","definition_or_measurement_approach":"Change from baseline in TWSTRS total score measured at all scheduled post-injection timepoints up to Week 36."}
- {"endpoint_text":"- Change from Baseline in the TWSTRS-Pain Subscale. The TWSTRS pain subscale consists of three patient-rated items that assess the participants usual, worst and best pain from the preceding week, and the subscore has a maximum of 20. [Time Frame: At all timepoints post injection until Week 36.]","definition_or_measurement_approach":"Change from baseline in TWSTRS pain subscale (three patient-rated items; max subscore 20) at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Change from baseline in the daily Numerical Rating Scale (NRS) score [Time Frame: Averaged over every 7-day period until the Week 4 visit]","definition_or_measurement_approach":"Change from baseline in daily NRS score, averaged over each 7-day period until Week 4."}
- {"endpoint_text":"- Time to onset of pain reduction Defined as the duration from the administration of the study injection to the first recorded instance of a minimum 2-point decrease in the Numeric Rating Scale (NRS) score. [Time Frame: From study injection to first timepoint at which at least 2-point reduction is observed in NRS score]","definition_or_measurement_approach":"Time from study injection to first recorded ≥2-point decrease in NRS score."}
- {"endpoint_text":"- Time to return of symptoms in responders (time from treatment to loss of 80% of peak treatment effect) [Time Frame: From randomization until Week 36]","definition_or_measurement_approach":"Time from treatment to loss of 80% of peak treatment effect in responders, measured from randomization until Week 36."}
- {"endpoint_text":"- Change from Baseline in the TWSTRS-Disability Subscale. The TWSTRS disability subscale assesses the effect that Cervical Dystonia (CD) has on the participant’s daily activities and the subscore has a maximum of 30 and consists of six items. [Time Frame: At all timepoints post injection until Week 36.]","definition_or_measurement_approach":"Change from baseline in TWSTRS disability subscale (6 items, max 30) at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Change from Baseline in the TWSTRS-Severity Subscale. The TWSTRS severity subscale rates the maximal excursion of the torticollis (degree of tilt or rotation), elevation, range of motion, etc. This severity subscore has a maximum subtotal of 35 and consists of 11 items. [Time Frame: At all scheduled timepoints post injection until Week 36]","definition_or_measurement_approach":"Change from baseline in TWSTRS severity subscale (11 items, max subtotal 35) at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Change from baseline in Clinical Global Impression of Severity (CGI-S) score. [Time Frame: At all timepoints post injection until Week 36.]","definition_or_measurement_approach":"Change from baseline in CGI-S score at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Clinical Global Impression of Change (CGI-C) score [Time Frame: At all timepoints post injection until Week 36.]","definition_or_measurement_approach":"CGI-C assessed at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Change from baseline in Patients' Global Impression of Severity (PGI-S) score [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Change from baseline in PGI-S score at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Patients' Global Impression of Change (PGI-S) score [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"PGI-C/PGI-S assessed at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Change from Baseline in the Cervical Dystonia Impact Profile (CDIP-58) total score. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Change from baseline in CDIP-58 total score at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation. [Time Frame: From baseline to Week 36.]","definition_or_measurement_approach":"Proportion of participants with any AE/TEAE/SAE/AESI/AEs leading to discontinuation from baseline to Week 36."}
- {"endpoint_text":"- Percentage of participants with clinically significant changes from baseline in Laboratory Parameters Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with clinically significant laboratory parameter changes as graded by investigator at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with clinically significant vital sign changes as graded by investigator at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Percentage of participants with clinically significant change from baseline in focused neurological/physical examinations. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with clinically significant changes on focused neurological/physical exams at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with clinically significant changes in 12-lead ECG readings at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Treatment-emergence of suicidal ideation/suicidal behaviour. The Columbia Suicide Severity Rating Scale (C-SSRS) will be used in this study for the evaluation of suicidal ideation and behaviour. [Time Frame: From baseline to Week 36.]","definition_or_measurement_approach":"Treatment-emergent suicidal ideation/behaviour assessed using C-SSRS from baseline to Week 36."}
- {"endpoint_text":"- Percentage of participants with Binding antibodies to IPN10200 [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with binding antibodies to IPN10200 at scheduled timepoints up to Week 36."}
- {"endpoint_text":"- Percentage of participants with neutralising antibodies to IPN10200. [Time Frame: At all timepoints post injection until Week 36]","definition_or_measurement_approach":"Proportion with neutralising antibodies to IPN10200 at scheduled timepoints up to Week 36."}
Recruitment
- Planned Sample Size
- 94
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent obtained from adult participants. Country-specific subject information and informed consent forms (ICFs) are provided (documents present for France, Poland, Germany, Spain, Italy, Czechia and English-language ICFs). Additional ICFs/materials for pregnant partners and data protection are present. No assent arrangements are indicated.
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 94
France
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 405
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- #250003
- Principal Investigator Name
- Giovanni Castelnovo
- Principal Investigator Email
- giovanni.castelnovo@chu-nimes.fr
- Contact Person Name
- Giovanni Castelnovo
- Contact Person Email
- giovanni.castelnovo@chu-nimes.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- #250004
- Principal Investigator Name
- Christine Tranchant
- Principal Investigator Email
- Christine.Tranchant@chru-strasbourg.fr
- Contact Person Name
- Christine Tranchant
- Contact Person Email
- Christine.Tranchant@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- #250005
- Principal Investigator Name
- Frederique Fluchere
- Principal Investigator Email
- frederique.fluchere@ap-hm.fr
- Contact Person Name
- Frederique Fluchere
- Contact Person Email
- frederique.fluchere@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- #250001
- Principal Investigator Name
- Marion Simonetta-Moreau
- Principal Investigator Email
- simonetta.m@chu-toulouse.fr
- Contact Person Name
- Marion Simonetta-Moreau
- Contact Person Email
- simonetta.m@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- #250002
- Principal Investigator Name
- Elena Moro
- Principal Investigator Email
- emoro@chu-grenoble.fr
- Contact Person Name
- Elena Moro
- Contact Person Email
- emoro@chu-grenoble.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 12-05-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 344
- Number Of Sites
- 8
- Number Of Participants
- 19
Sites
- Site Name
- Specjalistyczne Gabinety Sp. z o.o.
- Department Name
- #616008 Neurologia
- Principal Investigator Name
- Lucyna Horodecka-Wardega
- Principal Investigator Email
- lhwardega@specjalistycznegabinety.pl
- Contact Person Name
- Lucyna Horodecka-Wardega
- Contact Person Email
- lhwardega@specjalistycznegabinety.pl
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
- Department Name
- #616003 Neurologia
- Principal Investigator Name
- Magdalena Boczarska-Jedynak
- Principal Investigator Email
- m.boczarskajedynak@gmail.com
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- m.boczarskajedynak@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- #616006 Zespol Poradni Specjal., Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Slowik
- Principal Investigator Email
- slowik@cm-uj.krakow.pl
- Contact Person Name
- Agnieszka Slowik
- Contact Person Email
- slowik@cm-uj.krakow.pl
- Site Name
- Etg Neuroscience Sp. z o.o.
- Department Name
- #616001 Neurologia
- Principal Investigator Name
- Aleksandra Karbowniczek
- Principal Investigator Email
- a.karbowniczek@neuroscience.com.pl
- Contact Person Name
- Aleksandra Karbowniczek
- Contact Person Email
- a.karbowniczek@neuroscience.com.pl
- Site Name
- Eskulap Pabianice Sp z o.o.
- Department Name
- #616007 Neurologia
- Principal Investigator Name
- Malgorzata Tyslerowicz
- Principal Investigator Email
- m.tyslerowicz@eskulapbk.pl
- Contact Person Name
- Malgorzata Tyslerowicz
- Contact Person Email
- m.tyslerowicz@eskulapbk.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- #616005 Neurologia
- Principal Investigator Name
- Karolina Porebska
- Principal Investigator Email
- karolina.porebska@futuremeds.com
- Contact Person Name
- Karolina Porebska
- Contact Person Email
- karolina.porebska@futuremeds.com
- Site Name
- Provincial Specialist Hospital Them. J. Gromkowski
- Department Name
- #616004 Oddzial Neurologii z Pododdzialem Udarowym
- Principal Investigator Name
- Katarzyna Marianska
- Principal Investigator Email
- marianskakatarzyna@gmail.com
- Contact Person Name
- Katarzyna Marianska
- Contact Person Email
- marianskakatarzyna@gmail.com
- Site Name
- Provincial Specialist Hospital Them. J. Gromkowski (additional listed site)
Germany
- Earliest CTIS Part Ii Submission Date
- 23-04-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 357
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- St. Johannes Krankenhaus
- Department Name
- #276002: Neurologie
- Principal Investigator Name
- Sebastian Paus
- Principal Investigator Email
- sebastian.paus@gfo-kliniken-troisdorf.de
- Contact Person Name
- Sebastian Paus
- Contact Person Email
- sebastian.paus@gfo-kliniken-troisdorf.de
- Site Name
- curiositas ad sanum Studien und Beratungs GmbH
- Department Name
- 276003: Neurologie
- Principal Investigator Name
- Johannes Schwarz
- Principal Investigator Email
- j.schwarz@curiositas-ad-sanum.de
- Contact Person Name
- Johannes Schwarz
- Contact Person Email
- j.schwarz@curiositas-ad-sanum.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- #276004: Neurologie
- Principal Investigator Name
- Mathias Gelderblom
- Principal Investigator Email
- m.gelderblom@uke.de
- Contact Person Name
- Mathias Gelderblom
- Contact Person Email
- m.gelderblom@uke.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- #276001: Neurologie
- Principal Investigator Name
- Ebba Lohmann
- Principal Investigator Email
- ebba.lohmann@med.uni-tuebingen.de
- Contact Person Name
- Ebba Lohmann
- Contact Person Email
- ebba.lohmann@med.uni-tuebingen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 354
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- #724005: Neurologia
- Principal Investigator Name
- Lydia López Manzanares
- Principal Investigator Email
- lydia.lopez@salud.madrid.org
- Contact Person Name
- Lydia López Manzanares
- Contact Person Email
- lydia.lopez@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- #724002: Neurofisiología Clínica
- Principal Investigator Name
- Pablo Mir Rivera
- Principal Investigator Email
- pmir@us.es
- Contact Person Name
- Pablo Mir Rivera
- Contact Person Email
- pmir@us.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- #724004: Neurología
- Principal Investigator Name
- Javier Pagonabarraga Mora
- Principal Investigator Email
- jpagonabarraga@santpau.cat
- Contact Person Name
- Javier Pagonabarraga Mora
- Contact Person Email
- jpagonabarraga@santpau.cat
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- #724003: Neurocirugía
- Principal Investigator Name
- Raul Espinosa Rosso
- Principal Investigator Email
- raul.espinosarosso@alum.uca.es
- Contact Person Name
- Raul Espinosa Rosso
- Contact Person Email
- raul.espinosarosso@alum.uca.es
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 370
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- #380002: Sezione di Ricerca Neurofisiologia Traslazionale
- Principal Investigator Name
- Giulia Giannini
- Principal Investigator Email
- giannini.giulia3@gmail.com
- Contact Person Name
- Giulia Giannini
- Contact Person Email
- giannini.giulia3@gmail.com
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- #380003: Neurologia 1 - Malattia di Parkinson e Disturbi del Movimento
- Principal Investigator Name
- Roberto Eleopra
- Principal Investigator Email
- roberto.eleopra@istituto-besta.it
- Contact Person Name
- Roberto Eleopra
- Contact Person Email
- roberto.eleopra@istituto-besta.it
- Site Name
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino
- Department Name
- #380005: Sezione di Ricerca Neurofisiologia Traslazionale
- Principal Investigator Name
- Giuseppe Cosentino
- Principal Investigator Email
- giuseppe.cosentino@mondino.it
- Contact Person Name
- Giuseppe Cosentino
- Contact Person Email
- giuseppe.cosentino@mondino.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- #380004: SOC di Neurologia
- Principal Investigator Name
- Francesco Cavallieri
- Principal Investigator Email
- francesco.cavallieri@ausl.re.it
- Contact Person Name
- Francesco Cavallieri
- Contact Person Email
- francesco.cavallieri@ausl.re.it
- Site Name
- Istituto Auxologico Italiano
- Department Name
- #380001: UO Neurologia
- Principal Investigator Name
- Alberto Doretti
- Principal Investigator Email
- a.doretti@auxologico.it
- Contact Person Name
- Alberto Doretti
- Contact Person Email
- a.doretti@auxologico.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna (additional listed site)
Sponsor
Primary sponsor
- Full Name
- Ipsen Innovation
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- 1,10,11,12,13,14,2,5,6,8,9
Third parties
- {"country":"France","full_name":"Eurofins BioPharma Product Testing Biologics","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1,10,11,12,13,14,2,5,6,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"15 (PFT)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"15 (Patient expenses reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Mapi Life Sciences UK Limited","duties_or_roles":"15 (patient questionnaires)","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- IPN10200
- Active Substance
- CLOSTRIDIUM BOTULINUM, NEUROTOXIN SEROTYPE A/B
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intramuscular
- Route
- INTRAMUSCULAR USE
- Investigational Product Name
- Placebo of IPN10200
- Modality
- Other
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