Pregabalin Versus Levetiracetam In Partial Seizures 


Tracking Information

Start Date  ICMJEOctober 2007
Estimated Primary Completion DateMay 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)		The primary outcome is efficacy - the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, as measured from baseline (data collected during 6 weeks). [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: September 27, 2007)		The primary outcome is efficacy - the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, as measured from baseline (data collected during 6 weeks).
Change HistoryComplete list of historical versions of study NCT00537238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 19, 2007)
  • Change in seizure count frequency from baseline to endpoint, calculated as the % change in 28-day seizure frequency during the maintenance phase of treatment compared with baseline. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Change in frequency of secondarily generalized tonic-clonic seizures [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • MOS-Sleep Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability; [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
  • Seizure free rate [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: September 27, 2007)		Safety and tolerability - Change in seizure count frequency from baseline to endpoint, calculated as the percent change in 28 day seizure frequency during the maintenance phase of treatment compared with baseline.

Descriptive Information

Brief Title  ICMJEPregabalin Versus Levetiracetam In Partial Seizures
Official Title  ICMJEA Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
Brief Summary

This study will compare pregabalin and leveracitam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Partial Seizures
  • Epilepsies, Partial
  • Partial Seizure Disorder
  • Complex Partial Seizure Disorder
  • Epilepsy
Intervention  ICMJE
  • Drug: pregabalin
    300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
  • Drug: levetiracetam
    1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Study Arms / Comparison Groups
  • B: Active Comparator
    Intervention: Drug: pregabalin
  • A: Active Comparator
    Intervention: Drug: levetiracetam

Recruitment Information

Estimated Enrollment  ICMJE570
Estimated Completion DateMay 2012
Estimated Primary Completion DateMay 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
  • Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
  • Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
  • Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEBelgium,   Bulgaria,   Colombia,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Turkey,   Venezuela

Administrative Information

NCT ID  ICMJENCT00537238
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA0081157
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer