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Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.

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ClinicalTrials.gov Identifier: NCT00141427
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 25, 2008
Information provided by:

Brief Summary:
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.

Condition or disease Intervention/treatment Phase
Seizures Drug: Pregabalin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
Study Start Date : November 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Pregabalin
U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction in seizure frequency.

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

Inclusion Criteria:

  • Male and female subjects with a diagnosis of partial epilepsy.
  • 18 years and older.

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 ClinicalTrials.gov identifier (NCT number): NCT00141427

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

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00141427     History of Changes
Other Study ID Numbers: A0081005
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: June 2006

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