Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

NCT00524030

Last updated date
Study Location
Pfizer Investigational Site
Northport, Alabama, 35476, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
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

- Diagnosis of epilepsy with partial seizures.

- Males or females, age 18 years or older.

- Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.

- Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

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


- Current diagnosis of febrile seizures or seizures related to an ongoing acute medical
event.


- Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or
infectious origin.


- Primary generalized epilepsy or status epilepticus within the previous year.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Official Title  ICMJE A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Brief Summary This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.
Detailed Description After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.
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 Epilepsies, Partial
Intervention  ICMJE
  • Drug: pregabalin 600 mg/day
    pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
  • Drug: pregabalin 150 mg/day
    pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin 600 mg/day
  • Experimental: 2
    Intervention: Drug: pregabalin 150 mg/day
Publications * French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
161
Original Enrollment  ICMJE
 (submitted: August 30, 2007)
250
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of epilepsy with partial seizures.
  • Males or females, age 18 years or older.
  • Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
  • Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion Criteria:

  • Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
  • Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
  • Primary generalized epilepsy or status epilepticus within the previous year.
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 Czechia,   Hong Kong,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00524030
Other Study ID Numbers  ICMJE A0081047
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 December 2018

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