Estudio abierto de extensión de un estudio doble ciego, aleatorizado, controlado con placebo y multicéntrico, para evaluar la eficacia y la seguridad de zonisamida como tratamiento adyuvante en crisis epilépticas parciales en pediatría
- Conditions
- EpilepsiaMedDRA version: 9.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
- Registration Number
- EUCTR2007-000198-53-ES
- Lead Sponsor
- Eisai Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
1.Subject has completed the double-blind study, E2090-E044-312.
2.Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
3.Subject is male or female aged 6?18 years inclusive, who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent.
4.Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 body weight < 20 kg.
2.Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 ?mol/l (1.5 mg/dl).
3.Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
4.Subject has a history of sensitivity to sulfonamide drugs or to zonisamide and its excipients.
5.Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilisation, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication.
NOTE: Should a female subject become of child bearing potential during the study, they must be re-consented in order to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
6.Subject has a recent history of excessive alcohol use or drug abuse.
7.Subject has a history of suicide attempt.
8.Subject has a clinically significant organic disease.
9.Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study.
10.Frequent need of rescue benzodiazepines (one or more times a month).
11.Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity.
12.Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of zonisamide used as an adjunctive treatment in paediatric subjects treated with one or two other anti-epileptic drugs (AEDs).;Secondary Objective: To assess long term maintenance of efficacy.;Primary end point(s): The primary efficacy parameter is the proportion of responders. A responder is defined as a subject with a decrease from baseline in seizure frequency of ? 50% during the study.
- Secondary Outcome Measures
Name Time Method