A randomized, double-blind extension study to assess long-term safety and to explore long-term efficacy of zonisamide as monotherapy in newly diagnosed partial epilepsy
- Conditions
- EpilepsyMedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy
- Registration Number
- EUCTR2008-001159-23-SE
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 582
1. Subject has completed study E2090-E044-310.
2. Subject is able and willing to give written informed consent.
3. Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects of childbearing potential must be non-pregnant, non-lactating and abide by one of the following medically acceptable contraceptive measures: oral contraceptive pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months, vasectomised partner or abstinence throughout the study and for one month after discontinuation of study medication. When the contraceptive pill is used, this should contain no less than 50 µg oestrogen.
4. The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range
1. Subject has a history of a significant or currently uncontrolled disease that will contraindicate the use of the study drugs or interfere with the conduct of this study and/or the assessment of safety and efficacy of the study drugs.
2. Subject has a body weight <40 kg.
3. Subject has a newly occurring progressive malignancy during study E2090-E044-310 (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
4. Subject has developed a psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months and is considered un-controlled; history of suicide attempt, alcohol or drug abuse, chronic treatment with benzodiazepines or barbiturates.
5. Subject is currently taking carbonic anhydrase inhibitors.
6. Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
7. Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
8. Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
9. Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.
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 and to explore the long-term efficacy of zonisamide when given as monotherapy to newly diagnosed subjects with partial seizures.;Secondary Objective: To provide for continued treatment of patients with randomized trial medication.<br><br>To explore the long-term efficacy of zonisamide as monotherapy treatment in partial seizures compared to carbamazepine.<br><br>To assess the Quality of Life (QoL) of subjects taking zonisamide as monotherapy treatment in partial seizures compared to carbamazepine.<br>;Primary end point(s): The primary analysis will present the retention rate.<br>Time to drop-out due to lack of efficacy or time to drop out due to an AE will be calculated from the start of E2090-E044-310 (i.e. randomization). Kaplan-Meier plots will be produced. This analysis will include data from study E2090-E044-310.
- Secondary Outcome Measures
Name Time Method