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NCT00141414 Clinical Trial

To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

Epilepsy, Partial Clinical Trial

Official title:
Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141414
Other study ID # 1008-008
Secondary ID
Status Completed
Phase Phase 2
First received August 30, 2005
Last updated December 28, 2006
Start date November 1997
Est. completion date October 2005

Study information
Verified date December 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the long-term safety of pregabalin in refractory partial epilepsy.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must have met the inclusion criteria for preceding double-blind study.

- Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

- Pregnant or considering becoming pregnant.

- Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

Locations
Country Name City State
Germany Pfizer Investigational Site Bonn
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Chesterfield Missouri
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site St. Paul Minnesota
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
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Completed NCT00150709 - A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Phase 3
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Completed NCT00152503 - Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam Phase 2
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