ClinicalTrials.gov
ClinicalTrials.gov Menu

To Evaluate the 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: NCT00141388
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To evaluate the 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 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 : July 1998
Actual Study Completion Date : October 2005





Primary Outcome Measures :
  1. Safety Efficacy


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 the preceding double-blind study
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot have absence seizures.

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): NCT00141388


  Show 56 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00141388     History of Changes
Other Study ID Numbers: 1008-010
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009

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