Status:
COMPLETED
Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The relationship between hormone cycling/fluctuations and the occurrence of seizures in women has received considerable discussion in the medical literature. This study investigated the efficacy and t...
Eligibility Criteria
Inclusion
- Non-pregnant and non-nursing females between the ages of 18 - 45 years of age;
- out-patients with epilepsy experiencing uncontrolled simple and/or complex partial seizures with or without secondary generalization for a minimum of 2 years;
- classifiable epilepsy according to the International Classification of Epileptic Seizures;
- minimum of 2 seizures per 4 weeks during the Baseline Period, without exceeding 100 seizures per 4 weeks. The majority of seizures (\>50%) must be partial onset, with or without secondary generalization;
- exhibited, during the Baseline Period, a catamenial epilepsy type C1 pattern defined as at least a 70% increase of weekly seizure frequency during the menstrual phase compared to the luteal and follicular phases combined;
- concurrent C2 catamenial epilepsy, defined as a 70% increase in daily seizure average during the ovulatory phase in comparison to the follicular and luteal phases combined, was permitted;
- taking a minimum of one and a maximum of two antiepileptic drugs at a stable dose for a period of 4 weeks prior to the selection visit and during the duration of the trial;
- vagal nerve stimulator (VNS) was permitted.
Exclusion
- using felbatol and presented clinically significant abnormalities with WBCs, RBCs, platelets, and/or hepatic function during felbatol treatment, and taking felbatol less than one year from the date of the Selection Visit;
- partial onset seizures uncountable due to clustering during the last 3 months;
- hormonal contraceptives that block menses within 6 months of the selection visit with no washout period permitted;
- menstrual cycle length less than 21 days and greater than 35 days during the baseline evaluation;
- alternative medications documented or purported to impact reproductive hormone levels, within the prior 2 months with no washout period permitted;
- significantly irregular menstrual cycles or a history of frequent amenorrhea defined as two episodes within the preceding 6 months;
- not taking hormonal contraceptives with more than one anovulatory cycle during the Baseline Period;
- clinically significant medical condition requiring treatment, except for the study indication, which would prevent clear interpretation of the study results;
- using the following classes of medications influencing the central nervous system: antipsychotics (typical and atypical), psychostimulants (except those containing methylphenidate, dextroamphetamine, or amphetamine used in the treatment of Attention Deficit Disorder), and hypnotics;
- chronically dosing with benzodiazepines;
- hospitalized for depression within 3 months prior to the selection visit.
- history of attempting suicide within the last 3 years, or suicidal ideation within the last 3 months;
- recent history (within the past two years) or presence of significant alcohol abuse or drug abuse;
- clinical history of significantly impaired renal function with a estimate of creatinine clearance below 80 ml/min;
- history of clinically significant cardiac conditions;
- ALT/SGPT, AST/SGOT, alkaline phosphatase, or ?-GT value of more than 3 times the upper limit of the central laboratory reference value;
- presence of a terminal illness;
- presence of any clinically significant allergic condition to levetiracetam or pyrrolidone derivatives;
- neutrophil count of less than 1800 per ?L.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00630630
Start Date
November 1 2002
End Date
November 1 2003
Last Update
November 26 2013
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