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
- Conditions
- Epilepsy
- Registration Number
- EUCTR2006-000156-40-FR
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 582
1.Male or female subjects, 18 to 75 years of age inclusive.
2.Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) or generalized tonic clonic seizures (without clear focal origin)within 12 months of the Screening Visit, of which at least one seizure occurred within three months of the Screening Visit (> one seizure within a 24 hour period will be counted as one seizure).
3.Subjects will either have had no previous use of an AED, or treatment with one AED for a maximum duration of two weeks, before the Randomization Visit (T1).
4.Subjects have a documented electroencephalogram (EEG) within 12 months of the Screening Visit, compatible with localization-related epilepsy (to exclude primary generalized epilepsy).
5.Subjects have a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the absence of a progressive neurological lesion within 12 months of the Screening Visit.
6.Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and randomization, must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. Medically acceptable contraception is defined here as oral contraception pill with at least 50 micrograms ethinylestradiol per intake, contraceptive injections and implants, or intrauterine device in place for at least three months.
7.Subjects who are able and willing to follow investigational study procedures, maintain a seizure diary, and report AEs.
8.Subjects who are able and willing to give 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
1.Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
2.Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
3.Subjects have a history of status epilepticus, and or non-epileptic seizures (e.g. metabolic, pseudo-seizures).
4.Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
5.Subjects have progressive encephalopathy or findings consistent with progressive CNS systems, disease or lesion (e.g. infection, demyelination, or tumour).
6.Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
7.Subjects have been previously treated with carbamazepine or zonisamide.
8.Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
9.Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
10.Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
11.Subjects have a history of acute intermittent porphyria.
12.Subjects have a history of renal disorder (serum creatinine level of > 135 µmol / l (1.5 mg/dL) at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper normal limit.
13.Subjects have a body weight of less than 40 kg.
14.Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
15.Subjects have a history of psychiatric illness or mood disorder requiring electro convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
16.Subjects are currently taking carbonic anhydrase inhibitors
17.Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
18.Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other prohibited medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The proportion of subjects remaining seizure free for at least a 26 week period when treated with zonisamide or carbamazepine. A subject will be classified as having achieved a 26 week seizure free period if they are free of all seizures, regardless of seizure type, for 26 weeks when on a stable dose of carbamazepine or zonisamide.<br>;Main Objective: To assess the efficacy of zonisamide compared to carbamazepine when given as monotherapy to newly diagnosed subjects with partial seizures by assessment of 26 weeks seizure free rate.;Secondary Objective: To further explore the efficacy of zonisamide compared to carbamazepine.<br><br>To assess the safety and tolerability of zonisamide compared to carbamazepine.<br><br>To assess the Quality of Life (QoL) of subject’s taking zonisamide compared to carbamazepine.<br>
- Secondary Outcome Measures
Name Time Method