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To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Seizure Disorder
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

- Must have met the inclusion criteria for the preceding double-blind study

- Have received double-blind study medication and wish to receive open-label
pregabalin.

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

- Cannot have absence seizures.

NCT00141388
Pfizer
Completed
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

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Descriptive Information
Brief Title  ICMJE To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures
Official Title  ICMJE Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Brief SummaryTo evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures.
Detailed DescriptionNot 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 Seizure Disorder, 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
Actual Enrollment  ICMJE
 (submitted: November 5, 2009)
455
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
500
Actual Study Completion Date  ICMJE October 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have met the inclusion criteria for the preceding double-blind study
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot have absence seizures.
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141388
Other Study ID Numbers  ICMJE 1008-010
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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