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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141427
First received: August 31, 2005
Last updated: March 21, 2008
Last verified: June 2006
History of Changes
  Purpose

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 Intervention Phase
Seizures
 Drug: Pregabalin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial

Resource links provided by NLM:

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reduction in seizure frequency.

Estimated Enrollment: 540
Study Start Date: November 2004
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141427

  Hide Study Locations
Locations
Belgium
Pfizer Investigational Site
Brugge, Belgium, 8000
Pfizer Investigational Site
Brussels, Belgium, B-1070
Pfizer Investigational Site
Duffel, Belgium, 2570
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Liege, Belgium, B-4000
Pfizer Investigational Site
Tielt, Belgium, 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
Marseille, Cedex 05, France, 13005
Pfizer Investigational Site
Montpellier, Cedex 5, France, 34295
Pfizer Investigational Site
Lyon, Cedex, France, 69694
Pfizer Investigational Site
Bayonne, France, 64109
Pfizer Investigational Site
Bordeaux Cedex, France, 33076
Pfizer Investigational Site
Grenoble Cedex, France, 38043
Pfizer Investigational Site
Lille Cedex, France, 59037
Pfizer Investigational Site
Marseille, France, 13009
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Nice Cedex, France, 06031
Pfizer Investigational Site
Paris, France, 75014
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Rennes, France, 35033
Pfizer Investigational Site
Strasbourg, France, 67091
Pfizer Investigational Site
Toulouse, France, 31403
Pfizer Investigational Site
Tours, France, 37044
Netherlands
Pfizer Investigational Site
Den Haag, ZH, Netherlands, 2512 VA
Pfizer Investigational Site
Alkmaar, Netherlands, NL-1815 JD
Pfizer Investigational Site
Breda, Netherlands
Pfizer Investigational Site
Heeze, Netherlands, 5591 VE
Pfizer Investigational Site
Hilversum, Netherlands, NL-1213 XZ
Pfizer Investigational Site
Oss, Netherlands, 5342 BT
Pfizer Investigational Site
SW Heemstede, Netherlands, 2103
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, 02-957
Pfizer Investigational Site
Warszawa, Poland, 02-097
Pfizer Investigational Site
Wroclaw, Poland, 50-420
Portugal
Pfizer Investigational Site
Braga, Portugal, 4701-965
Pfizer Investigational Site
Funchal, Portugal, 9000-168
Pfizer Investigational Site
Lisboa, Portugal, 1169-050
Pfizer Investigational Site
Matosinhos, Portugal, 4454-509
Pfizer Investigational Site
Ponta Delgada, Portugal, 9500-370
Pfizer Investigational Site
Porto, Portugal, 4099-001
Pfizer Investigational Site
Unknown, Portugal, 3000-075 3049
Switzerland
Pfizer Investigational Site
Lausanne, Switzerland, CH-1011
Pfizer Investigational Site
Zurich, Switzerland, 8008
Pfizer Investigational Site
Zurich, Switzerland, 8091
United Kingdom
Pfizer Investigational Site
Cambridge, Cambs, United Kingdom, CB2 2QQ
Pfizer Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Pfizer Investigational Site
Plymouth, Devon, United Kingdom, PL6 8DH
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT
Pfizer Investigational Site
Oxford, United Kingdom, OX2 6HE
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00141427     History of Changes
Other Study ID Numbers: A0081005
Study First Received: August 31, 2005
Last Updated: March 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Seizures
Epilepsy
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013