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, Inc.
ClinicalTrials.gov Identifier:
NCT00630630
First received: February 27, 2008
Last updated: November 25, 2013
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Levetiracetam
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percent change in catamenial seizure frequency.

Secondary Outcome Measures:
  • 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

Enrollment: 3
Study Start Date: November 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Levetiracetam
Other Name: Keppra, ucbL059
Placebo Comparator: 2 Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630630

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00630630     History of Changes
Other Study ID Numbers: N01088
Study First Received: February 27, 2008
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014