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To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

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ClinicalTrials.gov Identifier: NCT00141336
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 1, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To evaluate the long-term safety and tolerability 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)
Enrollment : 750 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabalin BID 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 : November 1999
Study Completion Date : July 2005





Primary Outcome Measures :
  1. Safety Tolerability


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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 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): NCT00141336


  Show 103 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00141336     History of Changes
Other Study ID Numbers: 1008-035
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 1, 2007
Last Verified: December 2006

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