Pregabalin In Partial Seizures Extension Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143130

Acronym

PREPS EXT

Enrollment

227

Registered

2005-09-02

Start date

2005-04-30

Completion date

2007-09-30

Last updated

2021-01-28

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

Conditions

Seizures

Keywords

phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

Brief summary

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

Interventions

DRUGPregabalin

Pregabalin

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

* 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

Design outcomes

Primary

Measure	Time frame
Reduction in seizure frequency.	18 months

Secondary

Measure	Time frame
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

Countries

Belgium, Finland, France, Poland, Portugal, Switzerland

Outcome results

None listed

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