- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693017
Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New South Wales
-
Chatswood, New South Wales, Australia, 2067
- Strategic Health Evaluators Pty Ltd
-
Randwick, New South Wales, Australia, 2031
- The Prince of Wales Hospital
-
-
Victoria
-
Heidelburg, Victoria, Australia, 3084
- Austin Health
-
Melbourne, Victoria, Australia, 3050
- The Royal Melbourne Hospital
-
-
-
-
HR
-
Split, HR, Croatia, 10000
- CH Split
-
Zagreb, HR, Croatia, 10000
- CH Sestre Milosrdnice University Hospita
-
Zagreb, HR, Croatia, 10000
- UHC Zagreb
-
-
-
-
-
Kralove, Czech Republic, 500 03
- Neurologicke oddeleni
-
Kromeriz, Czech Republic, 767 01
- Private Neurologi Office
-
Olomouc, Czech Republic, 775 20
- Fakultni nemocnice Olomouc
-
Ostrava, Czech Republic, 708 52
- Fakultni nemocnice s poliklinikou Ostrava
-
Plzen, Czech Republic, 305 99
- Fakultni nemocnice Plzen
-
Praha 5, Czech Republic, 150 30
- Nemocnice Na Homolce
-
Rychnov nad Kneznou, Czech Republic, 516 01
- Centrum neurologicke pece
-
-
-
-
-
Tallinn, Estonia, 10611
- West-Tallinn Central Hospital
-
Tallinn, Estonia, 11312
- Neurodiagnostica AP OY
-
Tartu, Estonia, 51014
- Tartu University Hospital
-
-
-
-
-
Kuopio, Finland, SF-70211
- Kuopio Epilepsy Center
-
Oulu, Finland, 90220
- Oulu University Central Hospital
-
-
-
-
-
Berlin, Germany, 10365
- Institut fur Diagnostik der Epilepsien (IDE) gGmbH Epilepsie-Zentrum Berlin- Brandenburg.
-
Freiburg, Germany, 79106
- Neurochirurgische Klinik der Universitat Freiburg
-
Marburg, Germany, 35039
- Interdisziplinares Epilepsiezentrum am Klinikum der Philipps-Universitat Marburg
-
Munchen, Germany, 80333
- Neurologische Gemeinschaftspraxis
-
Ulm, Germany, 89081
- Universitatsklinikum Ulm
-
-
-
-
-
Budapest, Hungary, 1021
- National Institute of Psychiatry and Neurology
-
Budapest, Hungary, 1089
- Heim Pal Hospital
-
Budapest, Hungary, 1091
- Szent Istvan Hospital
-
Budapest, Hungary, 1145
- Országos Idegsebészeti Tudományos Intézet
-
Budapest, Hungary, 1146
- Bethesda Hospital for Children
-
Gyula, Hungary, 5703
- Bekes County Pandy Kalman Hospital
-
Kecskemet, Hungary, 6000
- Bacs-Kiskun County ONK Hospital
-
Szombathely, Hungary, 9400
- Vas County Markusovszky Hospital
-
Veszprem, Hungary, 8200
- Veszprem County Csolnoky F. Hospital
-
-
-
-
-
Kaunas, Lithuania, 50009
- Kaunas Medical University Hospital
-
Kaunas, Lithuania, 50185
- Neuromeda
-
Vilnius, Lithuania, 8861
- Vilnius University Hospital Santariskiu Klinikos
-
-
-
-
-
Bialystok, Poland, 15-420
- Niepubliczny ZOZ KENDRON
-
Gdansk, Poland, 80-803
- Wojewozki Szpital Specjalistyczny im. M. Kopernika
-
Katowice, Poland, 40-635
- Specjalistyczny Szpital Wieloprofilowy
-
Krakow, Poland, 31-530
- Centrum Neurologii Klinicznej
-
Lodz, Poland, 93-513
- Szpital im. M. Kopernika
-
Poznan, Poland, 60-355
- Uniwersytet Medyczny
-
-
-
-
-
Bucharest, Romania, 050098
- Spitalul Universitar de Urgenta Bucuresti
-
Bucharest, Romania, 011025
- Centrul Medical Sana
-
Bucharest, Romania, 041914
- Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
-
Cluj-Napoca, Romania, 400006
- Spitalul Clinic Judetean de Urgenta Cluj
-
Lasi, Romania, 700111
- Spitalul Clinic Judetean de Urgenta "Sf Spiridon" Iasi
-
Lasi, Romania, 700309
- Spitalul Clinic de Urgenta "Sfanta Treime"
-
Tg Mures, Romania, 540136
- Spitalul Clinic Judetean de Urgenta Tg Mures
-
-
-
-
-
Krasnoyarsk, Russian Federation, 660022
- GOU VPO Krasnoyarskaya State Medical Academy of Roszdrav
-
Moscow, Russian Federation, 107076
- FGU Moscow Research Institute of Psychiatry of Roszdrav
-
Moscow, Russian Federation, 117997
- GOU VPO Russian State Medical University of Roszdrav
-
Moscow, Russian Federation, 119049
- GUZ of Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
-
Moscow, Russian Federation, 127473
- GOU VPO Moscow State University of Medicine and Dentistry of Roszdra
-
Novosibirsk, Russian Federation, 630091
- GOU VPO Novosibirsk State Medical University of Roszdrav
-
Smolensk, Russian Federation, 214018
- GOU VPO Smolensk State Medical Academy of Roszdrav
-
Smolensk, Russian Federation, 214019
- GOU VPO Smolensk State Medical Academy of Roszdrav
-
St. Petersburg, Russian Federation, 192019
- GU St. Petersburg Research Institute of Psychoneurology Bekhtereva of Roszdrav
-
St. Petersburg, Russian Federation, 194100
- St. Petersburg State Medical Pediatric Academy
-
St. Petersburg, Russian Federation, 197022
- GOU VPO St. Petersburg State Medical University
-
Yaroslavl, Russian Federation, 150000
- Yaroslavskaya State Medical Academy
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Center of Serbia
-
Belgrade, Serbia, 11000
- University Medical Center Zvezdara
-
Kragujevac, Serbia, 34000
- Clinical Center Kragujevac
-
Nis, Serbia, 18000
- Clinical Center of Nis
-
-
-
-
-
Dnipropetrovsk, Ukraine, 49005
- Tsentr Psihosomatychnoyi Patologiyi Dnipropetrovskoyi oblasnoyi klinichnoyi likarni imeni Mechnikova
-
Kharkiv, Ukraine, 61068
- Derzhavna Ustanova Institut Nevrologiy
-
Kyiv, Ukraine, 2660
- Kyiv City Psychiatric Hospital #2, Poliklinichne Viddilenya
-
Kyiv, Ukraine, 3080
- Miska Klinichna psihonevrologichna
-
Lviv, Ukraine, 7910
- Lvivskyiy oblasnyi Protyepileptuchnyy tsentr
-
Odesa, Ukraine, 65006
- Odesskyy Derzhavnyy Medychnyy Universitet
-
Vinnitsa, Ukraine, 21005
- Vinnitskyy Natsionalnyy Medychnyy Universitet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is male or female and aged 12-65 years.
- Subject has at least eight days with at least one myoclonic seizure over the two months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
- Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. Subjects below the age of consent in their country, must where appropriate be willing to give informed (written or verbal) assent. Subjects from the age specified in local regulations will be required to sign an appropriate informed consent form.
- Subject is taking a stable regimen of one or two other AEDs for at least two weeks prior to Visit 1 (start of the Baseline Period).
- Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE) which has myoclonic seizures (and which may be accompanied by other generalised seizure types), according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies and Epileptic Syndromes (1989). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan should have been performed within five years of the screening visit or, if not available from this period, should be performed in the Baseline Period.
- EEG should have been performed within one year of the screening visit or, if not available from this period, should be performed in the Baseline Period.
- Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating, or are post-menopausal.
- Female subjects of childbearing potential ≥ 18 years must abide by one of the following medically acceptable contraceptive measures: oral contraception pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months or vasectomised partner or abstinence throughout the study. Subjects <18 years and of childbearing potential must be either abstinent or willing to use one of the medically appropriate forms of contraception for the duration of the study.
Exclusion Criteria:
- Subject has progressive or focal neurological disease (as determined by preexisting brain imaging such as CT or MRI performed maximally five years before the screening visit), or clinically significant organic disease.
- Subject has a history of, or results of clinical investigations (including EEG data) that are suggestive of, partial seizures as defined by the ILAE, including generalised tonic clonic seizures which are suspected to be secondarily generalised.
- Subjects with cryptogenic or symptomatic generalised epilepsy.
- Subjects with psychogenic seizures.
- Subject has a history of convulsive status epilepticus within a year of screening while complying with AEDs.
- Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).
- Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- Subject has a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.
- Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of its excipients.
- Subject has a recent history of excessive alcohol use or drug abuse.
- Subject has a history of suicide attempt in the five years before the screening visit.
- Subject has abnormal screening laboratory values that are clinically significant.
- Subject has a history of demonstrated non-compliance with treatment, or the subject or parent/caregiver can be reasonably expected not to be compliant with study procedures or to complete the study.
- Subject has participated in a study of an investigational drug or device within 30 days prior to screening.
- Subject has received previous treatment with zonisamide.
- Subject is treated with ketogenic diet or vagus nerve stimulator.
- Subject has a history of necessary treatment with rescue benzodiazepines which is foreseen to continue during the study. Rescue benzodiazepines will not be allowed in this study (stable dosing with a benzodiazepine as (one of the) baseline anti-epileptic drug(s) is allowed).
- Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and drugs with anticholinergic activity.
- Current psychosis or moderate to severe depression, or use of anti-psychotic drugs, MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days before the screening visit.
- Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
- Subject is unable to swallow capsules.
- Subject is not in general good health as determined by medical history, physical exam and screening laboratory results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
50-400 mg Zonisamide Placebo capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks) |
Active Comparator: Zonisamide
|
50-400 mg capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Considered Responders as Assessed During the Maintenance Period
Time Frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)
|
The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16).
A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e.
28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]).
Occurrence of seizures was documented in a seizure diary.
The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit.
The diary was completed daily.
All seizures except myoclonic seizures were counted individually in the the diary.
Due to early termination of the study by the Sponsor, no formal analyses were conducted.
|
Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures
Time Frame: Baseline and up to 16 weeks
|
Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16).
Due to early termination of the study by the Sponsor, no formal analyses were conducted.
|
Baseline and up to 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rob van Maanen, M.D., Eisai Limited
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epileptic Syndromes
- Neurologic Manifestations
- Epilepsy
- Epilepsies, Myoclonic
- Seizures
- Epilepsy, Generalized
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Zonisamide
Other Study ID Numbers
- E2090-E044-317
- 2007-003556-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsy
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Zonisamide
-
Eisai Inc.Completed
-
Mutual Pharmaceutical Company, Inc.Completed
-
Eisai Korea Inc.Completed
-
Orexigen Therapeutics, IncCompleted
-
University of PittsburghEisai Inc.Withdrawn
-
Mutual Pharmaceutical Company, Inc.Completed
-
Elan PharmaceuticalsCompletedMigraine HeadacheUnited States
-
Elan PharmaceuticalsTerminatedBipolar Disorders
-
Washington University School of MedicineUnited States Department of Defense; University of Texas; Gateway Biotechnology...TerminatedHearing Loss, Noise-InducedUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedNicotine DependenceUnited States