Pregabalin In Partial Seizures Extension Study (PREPS EXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143130
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 5, 2015
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Brief Summary:
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Condition or disease Intervention/treatment Phase
Seizures Drug: Pregabalin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Single Arm Drug: Pregabalin

Primary Outcome Measures :
  1. Reduction in seizure frequency. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143130

  Show 47 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00143130     History of Changes
Other Study ID Numbers: A0081015
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs