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Pregabalin In Partial Seizures Extension Study (PREPS EXT)

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: NCT00143130
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief Summary:
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Condition or disease Intervention/treatment Phase
Seizures Drug: Pregabalin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
Study Start Date : April 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Single Arm Drug: Pregabalin
Pregabalin




Primary Outcome Measures :
  1. Reduction in seizure frequency. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Seizure-free patients during each 3-month period [ Time Frame: 18 Months ]
  2. Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [ Time Frame: 18 Months ]
  3. Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [ Time Frame: 18 Months ]


Information from the National Library of Medicine

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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:

  • met the inclusion/exclusion criteria for A0081005
  • have completed the 21-week study and have shown a significant clinical response and wish to continue treatment

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): NCT00143130


Locations
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Belgium
Pfizer Investigational Site
Brugge, Belgium, B-8000
Pfizer Investigational Site
Brussels, Belgium, 1070
Pfizer Investigational Site
Duffel, Belgium, B-2570
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Leuven, Belgium, B-3000
Pfizer Investigational Site
Liege, Belgium, 4000
Pfizer Investigational Site
Tielt, Belgium, B-8700
Pfizer Investigational Site
Yvoir, Belgium, 5530
Finland
Pfizer Investigational Site
Helsinki, Finland, 00250
Pfizer Investigational Site
Kuopio, Finland, 70210
Pfizer Investigational Site
Tampere, Finland, 33520
France
Pfizer Investigational Site
Paris, Cedex 14, France, 75674
Pfizer Investigational Site
Lille, Cedex, France, 59037
Pfizer Investigational Site
Lyon, Cedex, France, 69694
Pfizer Investigational Site
Marsille, Cedex, France, 13385
Pfizer Investigational Site
Rennes, Cedex, France, 35033
Pfizer Investigational Site
Bayonne, France, 64109
Pfizer Investigational Site
Bordeaux Cedex, France, 33076
Pfizer Investigational Site
Grenoble Cedex, France, 38043
Pfizer Investigational Site
Marseille 13, France, 13009
Pfizer Investigational Site
Montpellier Cedex 5, France, 34295
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Nice, France, Cedex 06002
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Pfizer Investigational Site
Paris Cedex 14, France, 75674
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Strasbourg, France, 67091
Pfizer Investigational Site
Toulouse, France, 31043
Pfizer Investigational Site
Tours Cedex, France, 37044
Poland
Pfizer Investigational Site
Katowice, Poland, 40-635
Pfizer Investigational Site
Krakow, Poland, 31-523
Pfizer Investigational Site
Lublin, Poland, 27-718
Pfizer Investigational Site
Warszawa, Poland, 00-416
Pfizer Investigational Site
Warszawa, Poland, 02-097
Pfizer Investigational Site
Warszawa, Poland, 02-957
Pfizer Investigational Site
Wroclaw, Poland, 50-420
Portugal
Pfizer Investigational Site
Braga, Portugal, 4701-965
Pfizer Investigational Site
Coimbra, Portugal, 3000-075
Pfizer Investigational Site
Funchal, Portugal, 9000-168
Pfizer Investigational Site
Lisboa, Portugal
Pfizer Investigational Site
Matosinhos, Portugal, 4454-509
Pfizer Investigational Site
Ponta Delgada, Portugal, 9500-370
Pfizer Investigational Site
Ponta Delgada, Portugal, 9500
Pfizer Investigational Site
Porto, Portugal, 4099-001
Switzerland
Pfizer Investigational Site
Lausanne, Switzerland, CH-1011
Pfizer Investigational Site
Zurich, Switzerland, CH-8008
Pfizer Investigational Site
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00143130    
Other Study ID Numbers: A0081015
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: March 2015
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
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