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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372528
First received: September 5, 2006
Last updated: September 21, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014