A multicentre, randomised, active comparator, parallel group study to compare the effect on cognition of adjunctive therapy with zonisamide versus sodium valproate.
- Conditions
- faling diseasePartial epilepsy10010335
- Registration Number
- NL-OMON32279
- Lead Sponsor
- Eisai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
1) Subjects with a diagnosis of non-symptomatic localisation-related epilepsy with partial onset seizures;
2) Male or female subjects aged >=18 years;
3) Subjects taking carbamazepine as monotherapy at baseline or who can be transferred to carbamazepine monotherapy in the two months before the Screening Visit;
4) Subjects requiring addition of another AED;
5) Female subjects of childbearing potential must not be pregnant.
1) Previous treatment with valproate or zonisamide.
2) Use of an AED other than carbamazepine less than 6 weeks prior to randomisation, and other than carbamazepine, zonisamide or sodium valproate during the study.
3) Hypersensitivity to zonisamide or valproate or their respective excipients.
4) Predisposing condition potentially altering the absorption, distribution or elimination of zonisamide or valproate.
5) Sulphonamide allergy.
6) Subjects with diagnosed idiopathic/primary generalised epilepsy or with results of clinical investigations.
7) History of status epilepticus within 12 months of screening whilst complying with AED therapy
8) History of cluster seizures.
9) History of non epileptic seizures.
10) Use of benzodiazepines during the Baseline Period or during randomised treatment.
11) Regular treatment with antihistamines.
12) Use of ketogenic diet.
13) Use of acetozolamide, triamterene, vitamin C (>2g/day), regular antacids or other medicines associated with nephrolithiasis less than one month prior to randomisation or during the study.
14) Subjects with a vagal nerve stimulator implanted, or due to be implanted within the expected duration of the study.
15) Subjects expected to undergo any surgery within the expected duration of the study.
16) History of renal calculi or renal insufficiency.
17) Active psychiatric disease.
18) History of suicide attempt within last 2 years.
19) History of drug or alcohol abuse within the last 2 years.
20) History of cerebrovascular disease/stroke or transient ischemic attacks; progressive neurological disease; focal central nervous system pathology or behavioural disturbances that may impair the subject*s ability to complete the neuropsychological tests; or previous or current brain neoplasm.
21) Neoplastic disease within the last 5 years.
22) Diagnosis of HIV or Hepatitis B or C.
23) Other clinically significant organic disease.
24) Female subjects who are lactating, pregnant or intending to become pregnant.
25) Subjects with history of demonstrated non compliance with medication or an inability to maintain a seizure diary
26) Subjects considered by the Investigator not to be within normal cognitive limits.
27) Participation in clinical study within 30 days of screening.
28) Clinically significant laboratory value abnormalities at baseline.
29) Weight <40kg.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The Primary Endpoint is the change from baseline to Week 12 in the CVST<br /><br>(Computerised Visual Searching Task Reaction Time) from the FePsy cognitive<br /><br>battery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The Secondary Endpoints include:<br /><br><br /><br>- the change from baseline to Week 6 in the CVST<br /><br>- the remainder of the FePsy cognitive battery at Weeks 6 and 12:<br /><br>• Measures of Motor Speed<br /><br>• Measures of Mental Speed<br /><br>• Memory Function<br /><br>- the Profile of Mood States at Weeks 6 and 12 (scale for state-dependent mood<br /><br>changes)<br /><br>- the ABNAS at Weeks 6 and 12 (measures subjective cognitive complaints, as<br /><br>reported by the subject)</p><br>