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Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

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.
ClinicalTrials.gov Identifier: NCT00150293
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Condition or disease Intervention/treatment Phase
Seizure Disorder, Partial Drug: Pregabalin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 337 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Study Start Date : March 2002
Estimated Study Completion Date : November 2005


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Safety Efficacy

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Must have met the inclusion criteria for preceding double-blind study
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot be pregnant or considering becoming pregnant during the course of the study.
  • Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00150293


  Show 83 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00150293     History of Changes
Other Study ID Numbers: 1008-114
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Seizures
Epilepsy
Epilepsies, Partial
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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs