To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
NCT00141414
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Must have met the inclusion criteria for preceding double-blind study.
- Have received double-blind study medication and wish to receive open-label pregabalin.
- Pregnant or considering becoming pregnant.
- Receiving any concomitant medication that could alter the effectiveness of their
medication response or seizure frequency.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy. | |||
Official Title ICMJE | Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy. | |||
Brief Summary | To evaluate the long-term safety of pregabalin in refractory partial epilepsy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Epilepsy, 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 | 82 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | October 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 | Germany, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00141414 | |||
Other Study ID Numbers ICMJE | 1008-008 | |||
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 |