An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
This study has been terminated.
(This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372528
First received: September 5, 2006
Last updated: September 21, 2012
Last verified: September 2012
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Purpose
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: pregabalin (LYRICA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Year 5 and follow-up (30 days after last dose) ] [ Designated as safety issue: Yes ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Secondary Outcome Measures:
- Mean Number of Seizures [ Time Frame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) ] [ Designated as safety issue: No ]Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.
| Enrollment: | 21 |
| Study Start Date: | March 2007 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pregabalin
open label treatment
|
Drug: pregabalin (LYRICA)
150 mg up to a maximum of 600 mg per day bid or tid as required
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
- Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest
Exclusion Criteria:
- Is pregnant or is considering becoming pregnant during the course of the study
- Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372528
Locations
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Barrie, Ontario, Canada, L4M 4S5 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5C 1R6 | |
| Pfizer Investigational Site | |
| Windsor, Ontario, Canada, N8X 5A6 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00372528 History of Changes |
| Other Study ID Numbers: | A0081140 |
| Study First Received: | September 5, 2006 |
| Results First Received: | September 21, 2012 |
| Last Updated: | September 21, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Pregabalin Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 19, 2013