A randomized, multi-centre, double -blind study to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy in newly diagnosed partial epilepsy. - MAZE

EISAI LTD UK0 个研究点目标入组 582 人2007年6月5日

适应症Partial Epilepsy MedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Partial Epilepsy
发起方: EISAI LTD UK
入组人数: 582
状态: 进行中（未招募）
最后更新: 14年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2007年6月5日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

EISAI LTD UK

入排标准

入选标准

•1\. Men and women aged between 18 \- 75 inclusive. 2\. Subjects with newly diagnosed untreated epilepsy who have experienced at least two documented, unprovoked seizures, evaluated clinically and classified as partial epileptic seizures (with or without secondary generalisation) or generalised tonic\-clonic seizures (without a clear focal origin) in the 12 months preceding the Screening visit, with at least one in the 3 months preceding the Screening visit. (more than one seizure in a 24 hour period will be considered as a single seizure). 3\. Subjects must not have previously used antiepileptic drugs (AED) or have received treatment with an AED for a maximum duration of two weeks before the Randomisation visit (T1\). 4\. Subjects with a documented electroencephalogram (EEG) carried out within the 12 months preceding the Screening visit, compatible with localisation\-related epilepsy (to exclude primary generalised epilepsy). 5\. Subjects with a documented computerised axial tomography (CAT) or a magnetic resonance (MR) scan which confirms the absence of a progressive neurological lesion, carried out within the 12 months preceding the Screening visit. 6\. Women who are not of child\-bearing age (postmenopausal for two years, women who have undergone a bilateral oophorectomy or tubal ligature, complete hysterectomy) are eligible. Women of child\-bearing age must not be pregnant, as confirmed by a negative pregnancy test during screening and randomisation, must not be breast\-feeding and must use a medically acceptable contraceptive method for the duration of the study and for one month after having stopped taking the study drug. Medically acceptable contraceptive methods are defined at this time as oral birth control pills containing at least 50 micrograms of ethynilestradiol for ingestion, contraceptive injections and implants or intrauterine devices implanted for at least three months. 7\. Subjects who are able and willing to follow the procedures planned by the study, keep a diary for epileptic seizures and report any AEs. 8\. Subjects who are able and willing to provide written informed consent.
•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

排除标准

•1\. Subjects with a past history of clinical examinations, including ECG data suggesting idiopathic generalised epilepsy according to the definition of the International League Against Epilepsy (ILAE). 2\. Subjects with a past history of epileptic seizures not of a myoclonic, clonic, tonic or atonic nature. 3\. Subjects with a past history of epileptic conditions or non epileptic seizures (for example, metabolic, pseudo\-epileptic seizures). 4\. Subjects with seizures related to narcotics, alcohol, acute diseases, mental retardation or subjects with seizures related to stressful situations. 5\. Subjects with progressive encephalopathy or results indicative of progressive CNS (central nervous system) diseases or lesions (for example infections, demyelinisation or tumours). 6\. Subjects with a past history of significant or currently uncontrolled pathologies which would interfere with the conduct of the study or the evaluation of the safety and efficacy of the study drug. 7\. Subjects previously treated with carbamazaepine or zonisamide. 8\. Subjects who have received a trial drug or device in the three months preceding the Screening visit. 9\. Subjects with known hypersensitivity to sulfonamides, dibenzazepine derivatives or tricyclic antidepressive drugs. 10\. Subjects with a past history of marrow depression, reduced platelet count or other forms of blood dyscrasia. 11\. Subjects with a history of acute intermittent porphyria. 12\. Subjects with a past history of renal disorders (serum levels of creatinine \>135 mol/l (1\.5 mg/dl) at the Screening visit), liver disorders or clinically significant abnormalities in liver function tests; aspartate aminotransferases (AST) and alanine aminotransferases (ALT) \>2 times the upper limit of normal ranges. 13\. Subjects with a body weight below 40 kg. 14\. Subjects with a past history of malignant progressive neoplasia in the preceding 5 years (with the exclusion of a past history of suitably treated non metastatic skin squamocellular carcinoma). 15\. Subjects with a past history of psychiatric diseases or mood disorders requiring electroconvulsive or pharmacological therapy in the preceding 6 months and considered to be uncontrolled; past history of suicide attempts, alcohol or narcotic abuse; chronic treatment with benzodiazepine or barbiturates. 16\. Subjects who are currently taking carbonic anhydrase inhibitors. 17\. Subjects with a past history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant abnormalities in laboratory tests or on electrocardiographs or uncontrolled hypertension. 18\. Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or other permitted drugs.