Pregabalin In Partial Seizures Extension Study

Phase 3

Completed

• Conditions: Seizures
• Interventions: Drug: Pregabalin

• Registration Number: NCT00143130
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Study Completion: 2007-09
• Status Verified: 2015-03
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Reduction in seizure frequency.	18 months

Secondary Outcome Measures

Name	Time	Method
Seizure-free patients during each 3-month period	18 Months
Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).	18 Months
Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).	18 Months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 Zurich, Switzerland