Pregabalin Versus Levetiracetam In Partial Seizures

NCT00537238

Last updated date
Study Location
Pfizer Investigational Site
Duffel, , B-2570, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Seizures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 epileptics within the
12 months prior to trial entry, or with seizures due to an underlying medical illness
or metabolic syndrome, will be excluded.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin Versus Levetiracetam In Partial Seizures
Official Title  ICMJE A 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 levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Partial Seizures
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  ICMJE
  • Active Comparator: B
    Intervention: Drug: pregabalin
  • Active Comparator: A
    Intervention: Drug: levetiracetam
Publications * Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2012)
509
Original Enrollment  ICMJE
 (submitted: September 27, 2007)
400
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 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 epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Colombia,   Costa Rica,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Panama,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Turkey,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537238
Other Study ID Numbers  ICMJE A0081157
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

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