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Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

A Double-blind, Randomised, Placebo-controlled Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

NCT00692003•Eisai Limited

View on ClinicalTrials.gov

Summary

Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).

Eligibility

Age

6 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is male or female and aged 6-65 years.
•2. Subject has ≥ 3 PGTCS over the two months before screening and during the eight weeks Baseline Period with at least one seizure in each one month period. PGTCS must occur in the context of Idiopathic Generalized Epilepsy (IGE) and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of IGE.
•3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. For subjects below the age of consent in their country, where appropriate they must 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.
•4. Subject is taking a stable regimen of one or two other Antiepileptic Drugs (AEDs) for at least two weeks prior to Visit 1 (start of the Baseline Period).
•5. Subject has a clinical diagnosis of any type of idiopathic generalized epilepsy which has PGTCS (and which may be accompanied by other generalized 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 generalized epilepsy. 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.
•6. 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.
•7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating or are post-menopausal.
•8. Female subjects of childbearing potential must abide by the 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.
•9. Subject has a body weight ≥ 20 kg.

Exclusion Criteria

•1. Subject has progressive or focal neurological disease (as determined by pre-existing brain imaging such as CT or MRI performed maximally five years before the screening visit), or clinically significant organic disease.
•2. 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 generalized tonic clonic seizures which are suspected to be secondarily generalized.
•3. Subjects with cryptogenic or symptomatic generalized epilepsy.
•4. Subjects with psychogenic seizures.
•5. Subject has a history of status epilepticus within a year of screening while complying with AEDs.
•6. Subject has seizures that only occur in clustered patterns.
•7. Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).
•8. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
•9. Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.
•10. Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.
+13 more criteria

Locations (73)

Strategic Health Evaluators Pty Ltd

Chatswood, New South Wales, Australia

The Prince of Wales Hospital

Randwick, New South Wales, Australia

Austin Health

Heidelburg, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

St. Vincents Hospital

Melbourne, Australia

CH Split

Split, HR, Croatia

CH Sestre Milosrdnice University Hospital

Zagreb, HR, Croatia

UHC Zagreb

Zagreb, HR, Croatia

Neurologicke oddeleni

Hradec Králové, Czechia

Private Neurologi Office

Kroměříž, Czechia

Key Dates

Start Date

August 1, 2008

Primary Completion Date

November 1, 2008

Completion Date

January 9, 2009

Last Updated

March 14, 2017

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Zonisamide

DRUG

Placebo

DRUG

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Epilepsy; Seizure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

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MEHMO Natural History and Biomarkers