To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
NCT00141245
Last updated date
ABOUT THIS STUDY
To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.
Study Location
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
Eligibility Criteria
condition
Partial Seizure Disorder
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Must have met the inclusion criteria for preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Exclusion Criteria
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- Cannot have absence seizures
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures. | |||
Official Title ICMJE | Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures. | |||
Brief Summary | To evaluate long-term safety and efficacy 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 | 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 | |||
Enrollment ICMJE | 325 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | November 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Australia, Austria, Belgium, Finland, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00141245 | |||
Other Study ID Numbers ICMJE | 1008-012 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |