Open Label Extension Study Following Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess Efficacy and Safety of Adjunctive Zonisamide in Primary Generalized Tonic-Clonic Seizures
- Conditions
- Primary generalised tonic-clonic seizures (PGTCS) in idiopathic generalised epilepsy (IGE)MedDRA version: 9.1Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizures
- Registration Number
- EUCTR2007-006695-10-HU
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 154
1. Subject is male or female and aged 6-66 years.
2. Subject has completed the double blind study E2090-E044-315.
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 ICF.
4. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating or are post-menopausal.
5. 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 and for 30 days after the last dose.
6. Subject has a body weight = 20 kg.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject has a clinically significant organic disease.
2. Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).
3. Subject has a known diagnosis of HIV or hepatitis B or C.
4. Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.
5. Subject has a history of sensitivity to sulfonamide drugs or zonisamide and/or its excipients.
6. Subject has a recent history of excessive alcohol use or drug abuse.
7. Subject has a history of suicide attempt in the five years before the screening visit.
8. 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.
9. Subject is treated with ketogenic diet of vagus nerve stimulator
10. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, benzodiazepine or barbiturate treatment for disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days before the screening visit.
11. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, St. Johns Wort or feverfew and drugs with anticholinergic activity.
12. Concomitant use of felbamate or use of felbamate during study E2090-E044-315) within 28 days before the screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To assess long-term maintenance of efficacy.;Main Objective: The objective of this study is to assess the long-term safety of zonisamide in subjects with primary generalized tonic-clonic seizures (PGTCS).<br><br>;Primary end point(s): Open label Treatment Period: zonisamide will be administered in open label fashion until zonisamide is approved for this indication or further development in this indication is stopped. In countries where no marketing authorization will be applied for, Eisai has a compassionate use policy which can be applied for if required after the end of this study.<br><br>The end of study is defined as database lock, as access to site information (for query resolution) is required following last subject last visit until database lock.
- Secondary Outcome Measures
Name Time Method