An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

NCT00372528 | Terminated Phase 3 Results

• 1 other identifier: A0081140
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  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.

  Baseline up to Year 5 and follow-up (30 days after last dose)

Secondary Outcomes (1)

• Mean Number of Seizures

  Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)

Study Arms (1)

pregabalin

EXPERIMENTAL

open label treatment

Drug: pregabalin (LYRICA)

Interventions

pregabalin (LYRICA) DRUG

150 mg up to a maximum of 600 mg per day bid or tid as required

pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (5)

Pfizer Investigational Site

Calgary, Alberta, T2N 2T9, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Pfizer Investigational Site

Barrie, Ontario, L4M 4S5, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5C 1R6, Canada

Location

Pfizer Investigational Site

Windsor, Ontario, N8X 5A6, Canada

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 26, 2021
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

CA (5)