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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 February 2014
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  
Countries of recruitment
Contacts
Name:   UCB Clinical Trial Call Center
Address: 
Telephone:
Email:
Affiliation:  +1 877 822 9493 (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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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