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OpenTrials
Completed

NCT Number: NCT00143130

Pregabalin In Partial Seizures Extension Study

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

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Key information

Conditions

Seizures Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Pregabalin

Primary outcomes

  1. Reduction in seizure frequency.

    Time frame: 18 months

Secondary outcomes

  1. Seizure-free patients during each 3-month period

    Time frame: 18 Months

  2. Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).

    Time frame: 18 Months

  3. Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).

    Time frame: 18 Months

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: PREPS EXT

Important dates

Study start
2005
Study completion
2007
First posted
Sep 2, 2005
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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