Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00630630
• Date of registration: 27/02/2008
• Primary sponsor: UCB, Inc.
• Public title: Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy
• Scientific title: A Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Adult Female Subjects (18 to 40 Years of Age) With C1 Catamenial Epilepsy
• Date of first enrolment: November 2002
• Target sample size: 3
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00630630
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Levetiracetam

Other: Placebo

Primary Outcome(s)

Percent change in catamenial seizure frequency.

Secondary Outcome(s)

Catamenial seizure frequency during each cycle

Catamenial seizure frequency separately for ovulatory and anovulatory cycles

Non-catamenial seizure frequency

Number of days free from seizures per week

Ratio of catamenial seizure frequency to non-catamenial seizure frequency

Responder rate

Safety

Seizure frequency of catamenial and non-catamenial combined

Secondary ID(s)

N01088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors