Pregabalin In Partial Seizures Extension Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

September 11, 2008

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Reduction in seizure frequency. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00143130 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Seizure-free patients during each 3-month period [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Pregabalin In Partial Seizures Extension Study

Official Title ^†

Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-Month Follow-on Open-Label, International, Multicenter Add-on Therapy Trial

Brief Summary

To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Seizures

Intervention ^†

Drug: Pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

227

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

met the inclusion/exclusion criteria for A0081005
have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

Exclusion Criteria:

Having a treatable cause of seizure.
Having a progressive neurological or systemic disorder

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium, Finland, France, Poland, Portugal, Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143130

Responsible Party

Clinical Trials Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.