EUCTR2006-002516-10-HU进行中（未招募）不适用
A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures. - AZTEC
Eisai Ltd0 个研究点目标入组 150 人开始时间: 2008年7月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients aged 65 years or over.
- •2.Patients able and willing to give written informed consent in accordance with ICH GCP guidelines.
- •3.Patients who are reliable and willing to make themselves available for visits to the Investigator site and study telephone calls.
- •4.Patients 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.
- •5.Patients able to complete the questionnaires used in this study.
- •6.Patients with localisation related epilepsy, with simple and/or complex partial seizures with or without secondary generalised seizures as defined by the International League Against Epilepsy (ILAE) criteria.
- •7.Patients who have at least one well documented seizure in the four weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
- •8.Patients will be 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.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with seizures attributed to metabolic causes (e.g. electrolyte disturbances, hyperglycaemia).
- •2.Patients with seizures which could be attributed to use of a drug.
- •3.Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- •4.Patients with a history of eating disorders or a body weight below 40 kg.
- •5.Patients with a history of blood dyscrasias.
- •6.Patients with a history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
- •7.Patients with an increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
- •8.Patients taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
- •9.Patients taking rifampicin or drugs with anticholinergic effects.
- •10.Patients taking carbonic anhydrase inhibitors or topiramate.
- •11.Patients with a history of pancreatitis.
- •12.Patients with a history of Stevens Johnson Syndrome.
- •13.Patients with elevated levels of serum creatine >165 mircomol, or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
- •14.Patients suffering from clinically significant psychiatric illness, psychological or behavioural problems (e.g. major depressive or bipolar disorder, psychotic disorders, delirium or incapacitating anxiety disorders) or other disorders, which could interfere with study participation.
- •15.Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
- •16.Patients with hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
- •17.Patients considered by the Investigator to be an unsuitable candidate for receiving zonisamide or considered unlikely to comply with the protocol.
- •18.Any patient who has a contraindication for zonisamide treatment.
- •19.Treatment with any investigational product/drug 30 days prior to the Screening Visit.
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