Open label Extension Study Following Double-blind, Randomized, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures associated with Idiopathic Generalized Epilepsy

Eisai Limited0 个研究点目标入组 110 人开始时间: 2008年8月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Subject is male or female and aged 12-66 years.
•2. Subject has completed the double blind study E2090-E044-317.
•3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form (ICF). 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. 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.
•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 human immunodeficiency virus (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 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 or 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-E044-317.

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