Clinical trial • Phase III • Neurology

Levetiracetam for Refractory focal-onset epilepsy | Drug-resistant focal onset seizures

Phase III trial of Levetiracetam for Refractory focal-onset epilepsy | Drug-resistant focal onset seizures.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Refractory focal-onset epilepsy | Drug-resistant focal onset seizures
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
11-02-2025

Trial design

Randomised, levetiracetam immediate-release (keppra) 1000 mg/day (500 mg bid) - active comparator (keppra 500 mg film-coated tablets repackaged/inserted into capsules for double-blind); placebo - masked keppra® placebo film-coated tablets (placebo tablet inside a capsule) and levetiracetam prolonged-release placebo granules; test product: levetiracetam xr 1000 mg/day (prolonged-release granules in sachet).-controlled Phase III trial in Germany, Bulgaria, Czechia and others.

Randomised
Yes
Comparator
Levetiracetam immediate-release (Keppra) 1000 mg/day (500 mg BID) - active comparator (Keppra 500 mg film-coated tablets repackaged/inserted into capsules for double-blind); Placebo - masked Keppra® placebo film-coated tablets (placebo tablet inside a capsule) and levetiracetam prolonged-release placebo granules; Test product: Levetiracetam XR 1000 mg/day (prolonged-release granules in sachet).
Target Sample Size
255
Trial Duration For Participant
168

Stratification factors

  • Age (<18 vs ≥18)

Eligibility

Recruits 255 paediatric patients.

Pregnancy Exclusion
Women who are currently pregnant, who intend to become pregnant during the study, or who are breastfeeding.
Vulnerable Population
Minors (adolescents) are included in some countries (ages 12–17 in Spain, Poland and Bulgaria). Country-specific assent and parental/guardian consent handling is provided: assent forms for adolescents (12–14 years and 14–17/15–17 depending on country) and parent/guardian informed consent forms are available (country-specific ICF/assent documents listed for Bulgaria, Czechia, Hungary, Italy, Poland, Spain, Romania, Greece, etc.). Minors require assent and a parent/guardian provides consent as per the country-specific ICF/assent documents.

Inclusion criteria

  • {"criterion_text":"- Male and female, between 12 and 80 years of age, both inclusive for Spain, Poland and Bulgaria while the other countries will include only adult subjects.\n- Willingness and capability to provide informed consent form (ICF), be compliant with study procedures such as eDiary completion, be compliant with background anti-seizure medication (ASM) and Investigational Medicinal Product (IMP) intake.\n- Diagnosis of epilepsy with Focal-onset seizures (FOS) with or without secondary generalization according to the International League Against Epilepsy Classification of epileptic seizures.\n- On stable doses of ASM for at least 4 weeks prior to screening. List of allowed ASM medications are provided in Appendix 18.2.\n- Confirmed drug-resistant FOS despite 1-3 stable ASM with at least 6 seizures during the 8 week observational period\n- Patients who have Vagal Nerve Stimulator (VNS) must have stable settings > 3 months prior to screening and expected to remain unchanged during the duration of the study\n- Females of childbearing potential, if not abstinent, should use a highly effective contraception, started 60 days prior to study entry and 30 days after end of study drug administration: Combined (Estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: -Oral -Intravaginal -Transdermal; Progesterone-only hormonal contraception associated with inhibition of ovulation -Oral -Injectable -Implantable; Intrauterine device; Intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner; Sexual abstinence. See Appendix 18.1 for additional details.\n- Females of non-childbearing potential: either surgically sterilized (e.g. bilateral tubal ligation), had undergone hysterectomy or is at least 1 year postmenopausal (amenorrhea duration of at least 12 months)\n- Sexually active males with partner of childbearing potential commit to use an acceptable method of birth control consistently and correctly (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 90 days after the last study drug administration."}

Exclusion criteria

  • {"criterion_text":"- Presence of primary generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.\n- Laboratory values at screening: •\tPlatelets < 100,000/mm3 •\tAbsolute neutrophil count < 1500/mm3 •\tHaemoglobin < 10.0g/dL •\tAspartate aminotransferase or alanine aminotransferase > 3x upper limit of normal •\tEstimated Glomerular Filtration Rate < 80\n- History of status epilepticus in the past 3 months prior to screening.\n- Seizure clusters where individual seizures cannot be counted.\n- History of non-epileptic seizures.\n- Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic or renal disease, neoplastic malignancies etc.) that in the opinion of the investigator could affect the subject's safety or trial conduct.\n- Neurodegenerative and other progressive neurological disorders.\n- Diagnosis of active psychiatric disease, except depressed subjects on stable doses of selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitors for at least 12 weeks prior to screening.\n- History of prior suicide attempt or imminent risk of self-harm based on investigator’s judgment or with a “yes” answer on item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSR-S).\n- History of drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) and/or positive drug screening other than prescribed drugs.\n- Body weight < 50kg.\n- Alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) in the past year.\n- Current use of levetiracetam.\n- Positive for hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) or Human Immunodeficiency Virus (HIV) infection at screening.\n- Subjects presenting symptoms of coronavirus disease COVID-19.\n- Known allergic reaction or intolerance to levetiracetam or other pyrrolidone derivatives or to any of the excipients.\n- Participation in a study involving administration of an investigational product within one month prior to screening or within five half-lives of the previous study investigational compound, whichever is longer.\n- Women who are currently pregnant, who intend to become pregnant during the study, or who are breastfeeding.\n- Subjects with a diagnosis of Congenital Short QT Syndrome (SQTS). Subjects with a family history of Congenital Short QT Syndrome (SQTS) or family history of sudden death of unknown cause.\n- The corrected QT interval by Fredericia (QTcF) ≥ 450 msec in male and 470 msec in female subjects."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.","definition_or_measurement_approach":"Percent change from baseline in weekly Focal Onset Seizures (FOS) over the 12-week double-blind treatment period. Baseline seizure frequency is assessed during the 8-week observation period prior to randomization."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline* in absolute FOS over the 12 week double-blind period.","definition_or_measurement_approach":"Change from baseline in absolute number of weekly FOS over the 12-week double-blind period (baseline from the 8-week observation period)."}
  • {"endpoint_text":"- Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period.","definition_or_measurement_approach":"Responder rate defined as ≥50% reduction from baseline in total weekly seizure frequency during the 12-week double-blind period."}
  • {"endpoint_text":"- Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period.","definition_or_measurement_approach":"Proportion of subjects achieving ≥50% reduction from baseline in total seizures during the 12-week double-blind period."}
  • {"endpoint_text":"- Number of days free of FOS over the treatment period of 12 weeks.","definition_or_measurement_approach":"Count of days without focal-onset seizures during the 12-week treatment period."}
  • {"endpoint_text":"- Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks).","definition_or_measurement_approach":"Categorical analysis of weekly FOS frequency change grouped into six reduction categories over the 12-week treatment period."}
  • {"endpoint_text":"- Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period.","definition_or_measurement_approach":"Change from baseline in QoLIE-31 (adults ≥18) and QoLIE-AD-48 (adolescents <18) scores over the study period."}
  • {"endpoint_text":"- Improving medication compliance and patient satisfaction with the treatment over the study period.","definition_or_measurement_approach":"Assessment of medication adherence (e.g. MMAS/Morisky scale) and patient-reported treatment satisfaction over the study period."}

Recruitment

Planned Sample Size
255
Recruitment Window Months
32
Consent Approach
Informed consent obtained via country-specific informed consent forms (ICFs). Adults provide their own consent (L1 main ICF documents). For minors (included in Spain, Poland, Bulgaria) assent forms are provided (country-specific assent forms for ages 12–14 and 14–17/15–17) and parent/guardian ICFs are available; pregnant participant/partner ICFs are also provided. Documents and questionnaires (ICFs, assent, parent/guardian forms) are provided in country-specific languages as listed in the document set.

Methods

  • Site-based recruitment through neurology clinics and hospitals (site lists and contacts provided per country).
  • Use of country-specific recruitment materials: study posters, study brochures and recruitment arrangements documents (K1/K2) available for multiple countries (e.g. Bulgaria, Czechia, Hungary, Italy, Poland, Spain, Romania, Greece).
  • GP letters to inform local general practitioners about the study (country-specific L2 GP letters listed).
  • Patient-facing materials including participant cards, reimbursement forms and seizure diaries provided to sites for recruitment/support.

Geography

Total Number Of Sites
55
Total Number Of Participants
134

Germany

Earliest CTIS Part Ii Submission Date
20-01-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
402
Number Of Sites
2
Number Of Participants
18

Sites

Site Name
Gesellschaft Fuer Epilepsieforschung
Department Name
Epileptology
Contact Person Name
Christian Brandt
Contact Person Email
christian.brandt@mara.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Neurology
Contact Person Name
Felicitas Becker
Contact Person Email
felicitas.becker@rku.de

Bulgaria

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
423
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Military Medical Academy
Department Name
Clinic “Nervous diseases”
Contact Person Name
Stefka Mantarova-Valkova
Contact Person Email
smanatarova@vma.bg
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Nervous Diseases
Contact Person Name
Sasho Kastrev
Contact Person Email
kastrev@hotmail.com
Site Name
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
Department Name
Clinic of children neurology - nervous diseases
Contact Person Name
Ivan Olegovich Litvinenko
Contact Person Email
i.o.litvinenko@gmail.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Department of movement disorders
Contact Person Name
Ivan Milanov
Contact Person Email
ubalnp@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Neurology
Contact Person Name
Penko Shotekov
Contact Person Email
admin@rilski.com
Site Name
Medical Center Neuro Ped Gen
Contact Person Name
Iglika Sotkova-Ivanova
Contact Person Email
iglika26@abd.bg
Site Name
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Department Name
Neurology
Contact Person Name
Dimitar Maslarov
Contact Person Email
maslarovdb@abv.bg
Site Name
Medical Center Vita 1 Ltd.
Department Name
Neurology
Contact Person Name
Plamen Petkov
Contact Person Email
pn.petkov@abv.bg
Site Name
Alexandrovska University Hospital
Department Name
Clinic Of Nervous Diseases
Contact Person Name
Ivaylo Tournev
Contact Person Email
umbal.aleksandrovska@gmail.com
Site Name
Diagnostic-Consultative Center 1 St Klementina Varna Ltd.
Department Name
Neurology
Contact Person Name
Stamenka Hristova
Contact Person Email
stamenkahristova@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
409
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
First Department of Neurology
Contact Person Name
Jitka Kocvarova
Contact Person Email
jitka.krizova@fnusa.cz
Site Name
Forbeli s.r.o.
Department Name
Neurology Ambulance
Contact Person Name
Michal Bajacek
Contact Person Email
mbajacek@yahoo.co.uk
Site Name
INEP medical s.r.o.
Department Name
Neurology Department
Contact Person Name
Tomas Nezadal
Contact Person Email
nezadal@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
442
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Semmelweis University (Amerikai Ut 57)
Department Name
Epileptológia
Contact Person Name
Anna Kelemen
Contact Person Email
kelemenanna@hotmail.com
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Neurológiai és Stroke Osztály
Contact Person Name
Attila Balázs
Contact Person Email
harcsa.eleonora@gmail.com
Site Name
Semmelweis University (Balassa J Utca 6)
Department Name
Neurológia
Contact Person Name
Dániel Bereczki
Contact Person Email
bereczki.daniel@semmelweis.hu
Site Name
Semmelweis University (Tuzolto Utca 7-9)
Department Name
Neurológia Osztály
Contact Person Name
Márk Kristóf Farkas
Contact Person Email
farkas.kristof@semmelweis.hu

Italy

Earliest CTIS Part Ii Submission Date
26-01-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
431
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Division I of Neurology
Contact Person Name
Alfonso Giordano
Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C. Neurologia
Contact Person Name
Giuseppe D'Orsi
Contact Person Email
giudorsi@yahoo.it
Site Name
Associazione Oasi Maria S.S.Onlus
Department Name
Department of Clinical Neuroscience
Contact Person Name
Maurizio Elia
Contact Person Email
melia@oasi.en.it
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Scienze della salute della donna, del bambino e di sanità pubblica
Contact Person Name
Domenica Immacolata Battaglia
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
U.O.C. Neuropsichiatria Infantile Ospedale della Donna e del Bambino
Contact Person Name
Francesca Darra
Contact Person Email
francesca.darra@univr.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
UOC Neurology
Contact Person Name
Giovanni Assenza
Contact Person Email
g.assenza@policlinicocampus.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Dipartimento Di Medicina dei Sistemi Universitá degli Studi di Roma “Tor Vergata”
Contact Person Name
Claudio Liguori
Contact Person Email
dott.claudioliguori@yahoo.it

Romania

Earliest CTIS Part Ii Submission Date
16-01-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
438
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Secția Clinică Neurologie
Contact Person Name
Szabo Reka
Contact Person Email
reka.szabo.85@gmail.com
Site Name
Elias University Emergency Hospital
Department Name
Secția Clinica Neurologie
Contact Person Name
Cristina-Aura Panea
Contact Person Email
cristinapanea16@gmail.com
Site Name
Institutul Clinic Fundeni
Department Name
Secția Neurologie I
Contact Person Name
Octaviana Adriana Dulamea
Contact Person Email
adrianadulamea@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
Neurologie II
Contact Person Name
Amalia Cornea
Contact Person Email
ama.cornea@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Brasov
Department Name
Secția Clinică Neurologie
Contact Person Name
Cristian Falup-Pecurariu
Contact Person Email
crisfp100@yahoo.co.uk
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Neurologie II
Contact Person Name
Jozsef Szasz
Contact Person Email
szaszneuro@yahoo.com
Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Secția Clinica Neurologie
Contact Person Name
Ioana-Raluca Mindruta
Contact Person Email
ioanamindruta@me.com
Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara (second entry)
Department Name
Neurologie I
Contact Person Name
Jianu Dragos Catalin
Contact Person Email
dcjianu@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor (additional site listing)
Site Name
Institutul Clinic Fundeni (additional site listing)

Spain

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
407
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Hospital La Milagrosa S.A.
Department Name
Epilepsy Unit
Contact Person Name
Mar Carreño Martinez
Contact Person Email
MCARRENO@clinic.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Neurology
Contact Person Name
Francisco Javier López González
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Pedro Jesús Serrano-Castro
Contact Person Email
pedro.serrano.c@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurology
Contact Person Name
Rosa Ana Saiz Diaz
Contact Person Email
rosaanas@ucm.es
Site Name
Hospital Del Mar
Department Name
Neurology
Contact Person Name
Rodrigo Alberto Rocamora Zúñiga
Contact Person Email
rrocamora@psmar.cat

Poland

Earliest CTIS Part Ii Submission Date
31-01-2025
Latest Decision Or Authorization Date
07-03-2026
Processing Time Days
400
Number Of Sites
10
Number Of Participants
26

Sites

Site Name
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie
Department Name
Clinical Paediatric Neurology
Contact Person Name
Barbara Prawdzic-Seńkowska
Contact Person Email
barbara.senkowska@interia.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Neurologii Rozwojowej
Contact Person Name
Maria Mazurkiewicz-Bełdzińska
Contact Person Email
mmazur@gumed.edu.pl
Site Name
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej W Pruszkowie
Department Name
Poradnia neurologiczna dla dzieci
Contact Person Name
Jolanta Strzelecka
Contact Person Email
jstrze@wp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Neurologiczna
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurolglabk@su.krakow.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddział Neurologiczny
Contact Person Name
Waldemar Fryze
Contact Person Email
wfryze@wss.gda.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Contact Person Name
Andrzej Szczudlik
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Contact Person Name
Konrad Rejdak
Contact Person Email
rejdakk@gmail.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Marta Żołnowska
Contact Person Email
marta.zolnowska@gmail.com
Site Name
Instytut Matki I Dziecka
Department Name
Children Neurology Clinic
Contact Person Name
Elżbieta Stawicka
Contact Person Email
elzbieta.stawicka@imid.med.pl
Site Name
Neurosphera Sp. z o.o.
Contact Person Name
Beata Zwolinska
Contact Person Email
beata.m.zwolinska@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
162
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Neurology Department
Contact Person Name
Anastasios Bonakis
Contact Person Email
bonakistasos@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Neorology Department
Contact Person Name
Efthimios Dardiotis
Contact Person Email
edar@med.uth.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
3rd Neurology Department
Contact Person Name
Dimitrios Kazis
Contact Person Email
dimitroskazis@auth.gr
Site Name
University General Hospital Of Ioannina
Department Name
Neorology Department
Contact Person Name
Sofia Markoula
Contact Person Email
smarkoula@uoi.gr

Sponsor

Primary sponsor

Full Name
Neuraxpharm Pharmaceuticals S.L.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Contract research organisations

Name
N&Sz StudyMaster Kft.
Responsibilities
Clinical research monitoring, regulatory affairs & study start-up services in Czech Republic, Hungary, Romania
Name
Siro Clinpharm Private Limited
Responsibilities
Clinical research monitoring, regulatory affairs & study start-up services in India.
Name
LLC Paspigioni
Responsibilities
Clinical research monitoring, regulatory affairs & study start-up services in Georgia

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Labelling, secondary packaging, storage and QP-release of the IMPs","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Intertek Ibérica Spain SLU","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Losan Pharma GmbH","duties_or_roles":"primary packaging in sachets","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Merative","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"France","full_name":"Neuraltra-SAS","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Spain","full_name":"Komtur Pharmaceuticals Iberia S.L.","duties_or_roles":"Sourcing and importing comparator pharmaceutical products","organisation_type":"Pharmaceutical company"}
  • {"country":"Serbia","full_name":"Vetprom Export-Import d.o.o.","duties_or_roles":"IMP Local Depot (Serbia)","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Global Regulatory Consumer Insights","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Hungary","full_name":"N&Sz StudyMaster Kft.","duties_or_roles":"Clinical research monitoring, regulatory affairs & study start-up services in Czech Republic, Hungary, Romania","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Novasco","duties_or_roles":"Patient expenses reimbursement services for European countries","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Bosnia and Herzegovina","full_name":"Medical Intertrade","duties_or_roles":"IMP Local Depot (B&H)","organisation_type":"Industry"}
  • {"country":"India","full_name":"Siro Clinpharm Private Limited","duties_or_roles":"Clinical research monitoring, regulatory affairs & study start-up services in India.","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"TransPerfect","duties_or_roles":"Licensing, Translation and Validation of Questionnaires.","organisation_type":"Industry"}
  • {"country":"Spain","full_name":"Welocalize","duties_or_roles":"Translation","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Medizone Germany GmbH","duties_or_roles":"Sourcing and importing comparator pharmaceutical products","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"UCB Pharma","duties_or_roles":"Manufacturing IMP comparator","organisation_type":"Industry"}
  • {"country":"Georgia","full_name":"LLC Paspigioni","duties_or_roles":"Clinical research monitoring, regulatory affairs & study start-up services in Georgia","organisation_type":"Industry"}
  • {"country":"Bulgaria","full_name":"Ivan-Asen Shishmanov","duties_or_roles":"","organisation_type":"Industry"}

Investigational products

Investigational Product Name
Levetiracetam XR
Active Substance
Levetiracetam
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
1000 mg/day
Dose Levels
1000 mg/day
Frequency
Once daily (extended-release)
Maximum Dose
1000 mg/day
Investigational Product Name
Keppra 500 mg film-coated tablets
Active Substance
Levetiracetam
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
EU/1/00/146/010
Starting Dose
1000 mg/day (500 mg BID)
Dose Levels
1000 mg/day (500 mg BID)
Frequency
500 mg twice daily (BID)
Maximum Dose
1000 mg/day
Investigational Product Name
Masked Keppra® placebo film-coated tablets (a placebo tablet inside a capsule)
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Frequency
Matching comparator/placebo schedule for blinding
Investigational Product Name
Levetiracetam prolonged-release placebo granules
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Frequency
Matching comparator/placebo schedule for blinding
Combination Treatment
Yes

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