Pregabalin In Partial Seizures Extension Study (PREPS EXT)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143130
First received: August 31, 2005
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Seizures
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-Month Follow-on Open-Label, International, Multicenter Add-on Therapy Trial

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reduction in seizure frequency. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seizure-free patients during each 3-month period [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: April 2005
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: Single Arm Drug: Pregabalin
Pregabalin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143130

  Show 47 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00143130     History of Changes
Other Study ID Numbers: A0081015
Study First Received: August 31, 2005
Last Updated: September 11, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pfizer:
phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014