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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00630630
First received: February 27, 2008
Last updated: November 25, 2013
Last verified: September 2009

February 27, 2008
November 25, 2013
November 2002
November 2003   (final data collection date for primary outcome measure)
Percent change in catamenial seizure frequency.
Same as current
Complete list of historical versions of study NCT00630630 on ClinicalTrials.gov Archive Site
  • Responder rate
  • Number of days free from seizures per week
  • Ratio of catamenial seizure frequency to non-catamenial seizure frequency
  • Catamenial seizure frequency during each cycle
  • Seizure frequency of catamenial and non-catamenial combined
  • Non-catamenial seizure frequency
  • Catamenial seizure frequency separately for ovulatory and anovulatory cycles
  • Safety
Same as current
Not Provided
Not Provided
 
Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy
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

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 tolerability of LEV treatment for subjects with catamenial exacerbation of partial onset seizures.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Epilepsy
  • Drug: Levetiracetam
    Other Name: Keppra, ucbL059
  • Other: Placebo
  • Experimental: 1
    Intervention: Drug: Levetiracetam
  • Placebo Comparator: 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
November 2003
November 2003   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00630630
N01088
No
Study Director, UCB
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP