Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Pregabalin BID Open-Label Add-On Trial: A Follow-Up 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

NCT00143143

Enrollment

300

Registered

2005-09-02

Start date

2001-09-30

Completion date

2006-02-28

Last updated

2006-07-24

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

Conditions

Epilepsies, Partial, Epilepsy, Complex Partial

Brief summary

The primary purpose of the protocol is to evaluate the long-term safety 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

* Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin * Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening * Be currently taking 1 to 3 AEDs.

Exclusion criteria

* Have a treatable cause of seizures * Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

Design outcomes

Primary

Measure	Time frame
Safety assessments are performed at quarterly visits up until the study is closed.	—

Secondary

Measure	Time frame
Seizure frequency is assessed throughout the study until the study is closed.	—

Countries

Austria, Canada, France, Germany, Italy, Lithuania, Spain, United Kingdom

Outcome results

None listed

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