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
Adult Trials: 18+ Years
- 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 | ||||