Pregabalin In Partial Seizures Extension Study

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00143130
• Date of registration: 31/08/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Pregabalin In Partial Seizures Extension Study PREPS EXT
• Scientific title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
• Date of first enrolment: April 2005
• Target sample size: 227
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00143130
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Finland, France, Poland, Portugal, Switzerland

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Seizures

Intervention(s)

Drug: Pregabalin

Primary Outcome(s)

Reduction in seizure frequency. [Time Frame: 18 months]

Secondary Outcome(s)

Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [Time Frame: 18 Months]

Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [Time Frame: 18 Months]

Seizure-free patients during each 3-month period [Time Frame: 18 Months]

Secondary ID(s)

A0081015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors