A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 36
- 主要终点
- Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
研究概览
简要总结
A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf.
- •Able to complete the questionnaires used in this study.
- •Localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the International League Against Epilepsy (ILAE) criteria.
- •Have at least one well documented seizure in the 4 weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
- •Receiving at least one, but not more than two other marketed AEDs as concomitant medication, and the dosage should be stable for at least four weeks before the Screening Visit.
排除标准
- •Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
- •Seizures which could be attributed to use of a drug.
- •Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- •A history of eating disorders or a body weight below 40 kg.
- •A history of blood dyscrasias.
- •A history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
- •An increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
- •Taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
- •Taking rifampicin or drugs with anticholinergic effects.
- •Taking carbonic anhydrase inhibitors or topiramate.
- •A history of pancreatitis.
- •A history of Stevens Johnson Syndrome.
- •Elevated levels of serum creatinine >165 Umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
研究组 & 干预措施
Zonisamide at targeted daily doses of 100-500 mg/day
干预措施: Zonisamide at targeted daily doses of 100-500 mg/day (Drug)
Placebo administered to match daily doses of 100-500 mg/day
干预措施: Placebo administered to match targeted daily doses of 100-500 mg/day (Drug)
结局指标
主要结局
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16
The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16
The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
次要结局
- Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period(Baseline and Month 4)
- Percentage of Responders During Last 28 Days of Maintenance Period(Baseline and Month 4)