Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150293

Enrollment

337

Registered

2005-09-08

Start date

2002-03-31

Completion date

2005-11-30

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizure Disorder, Partial

Brief summary

To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Interventions

DRUGPregabalin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* Cannot be pregnant or considering becoming pregnant during the course of the study. * Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

Design outcomes

Primary

Measure	Time frame
Safety Efficacy	—

Countries

Australia, Austria, Belgium, Canada, Germany, Netherlands, Poland, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026