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Trial record 1 of 1 for:    NCT00143143
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Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143143
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : July 24, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date July 24, 2006
Study Start Date  ICMJE September 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Safety assessments are performed at quarterly visits up until the study is closed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Seizure frequency is assessed throughout the study until the study is closed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
Official Title  ICMJE Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Brief Summary The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsies, Partial
  • Epilepsy, Complex Partial
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: September 1, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
  • Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
  • Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

  • Have a treatable cause of seizures
  • Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
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 Austria,   Canada,   France,   Germany,   Italy,   Lithuania,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143143
Other Study ID Numbers  ICMJE 1008-000-164
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2006

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