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Pregabalin Open-Label Extension Trial 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: NCT00143143
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : July 24, 2006
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Epilepsy, Complex Partial Drug: Pregabalin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 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: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Study Start Date : September 2001
Study Completion Date : February 2006





Primary Outcome Measures :
  1. Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcome Measures :
  1. Seizure frequency is assessed throughout the study until the study is closed.


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.


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

Inclusion Criteria:

  • Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
  • Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
  • Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

  • Have a treatable cause of seizures
  • Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

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): NCT00143143


Locations
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Austria
Pfizer Investigational Site
Innsbruck, Austria, A6020
Pfizer Investigational Site
Mauer Bei Amstetten, Austria, 3362
Pfizer Investigational Site
St Polten, Austria, A3100
Pfizer Investigational Site
Wien, Austria, 1090
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 2T9
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Pfizer Investigational Site
Barrie, Ontario, Canada, L4M 4S5
Pfizer Investigational Site
London, Ontario, Canada, N6A 5A5
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Pfizer Investigational Site
Trois Rivieres, Quebec, Canada, G8Z 4K4
France
Pfizer Investigational Site
Marseille, Cedex 05, France, 13005
Pfizer Investigational Site
Paris, Cedex 13, France, 75651
Pfizer Investigational Site
Montpellier, Cedex 5, France, 34295
Pfizer Investigational Site
Lille, Cedex, France, 59037
Pfizer Investigational Site
Rennes, Cedex, France, 35033
Pfizer Investigational Site
Colomiers, France, 31770
Pfizer Investigational Site
Dommartin Les Toul, France, 54201
Pfizer Investigational Site
Marseille Cedex 09, France, 13274
Pfizer Investigational Site
Strasbourg, France, 67091
Germany
Pfizer Investigational Site
Berlin, Germany, 10365
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Bielefeld, Germany, 33617
Pfizer Investigational Site
Bonn, Germany, 53127
Pfizer Investigational Site
Essen, Germany, 45147
Pfizer Investigational Site
Frankfurt, Germany, 60528
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Goettingen, Germany, D-37075
Pfizer Investigational Site
Kehl, Germany, 77694
Pfizer Investigational Site
Marburg, Germany, 35039
Pfizer Investigational Site
ULM, Germany, 89075
Italy
Pfizer Investigational Site
Firenze, Italy, 50122
Pfizer Investigational Site
Perugia, Italy, 06123
Pfizer Investigational Site
Pisa, Italy, 56126
Pfizer Investigational Site
Siena, Italy, 53100
Lithuania
Pfizer Investigational Site
Vilnius, Lithuania, 2600
Pfizer Investigational Site
Vilnius, Lithuania, LT-2600
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Donostia-San Sebastian, Spain, 20014
Pfizer Investigational Site
Gerona, Spain, 17007
Pfizer Investigational Site
Madrid, Spain, 28034
Pfizer Investigational Site
Madrid, Spain, 28040
United Kingdom
Pfizer Investigational Site
Glascow, Scotland, United Kingdom, G11 6NT
Pfizer Investigational Site
Fazakerley, Liverpool, United Kingdom, L9 7LJ
Pfizer Investigational Site
York, United Kingdom, Y031 8HE
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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ClinicalTrials.gov Identifier: NCT00143143    
Other Study ID Numbers: 1008-000-164
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: July 24, 2006
Last Verified: March 2006
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Epilepsy, Complex Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
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
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs