Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

NCT00143143 | Completed Phase 3

• 1 other identifier: 1008-000-164
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 46

Brief Summary

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

Conditions

Epilepsies, Partial; Epilepsy, Complex Partial

Outcome Measures

Primary Outcomes (1)

• Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcomes (1)

• Seizure frequency is assessed throughout the study until the study is closed.

Interventions

Pregabalin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (47)

Pfizer Investigational Site

Innsbruck, A6020, Austria

Location

Pfizer Investigational Site

Mauer bei Amstetten, 3362, Austria

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Sankt Pölten, A3100, Austria

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Vienna, 1090, Austria

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T5G 0B7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Barrie, Ontario, L4M 4S5, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Trois-Rivières, Quebec, G8Z 4K4, Canada

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Marseille, Cedex 05, 13005, France

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Paris, Cedex 13, 75651, France

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Montpellier, Cedex 5, 34295, France

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Lille, Cedex, 59037, France

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Rennes, Cedex, 35033, France

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Colomiers, 31770, France

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Dommartin-lès-Toul, 54201, France

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Marseille, 13274, France

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Strasbourg, 67091, France

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Berlin, 10365, Germany

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Berlin, 13353, Germany

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Bielefeld, 33617, Germany

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Bonn, 53127, Germany

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Essen, 45147, Germany

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Frankfurt, 60528, Germany

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Freiburg im Breisgau, 79106, Germany

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Göttingen, D-37075, Germany

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Kehl, 77694, Germany

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Marburg, 35039, Germany

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Ulm, 89075, Germany

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Florence, 50122, Italy

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Perugia, 06123, Italy

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Pisa, 56126, Italy

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Siena, 53100, Italy

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Vilnius, 2600, Lithuania

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Vilnius, LT-2600, Lithuania

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Barcelona, Barcelona, 08036, Spain

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Girona, Gerona, 17007, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28040, Spain

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Donostia / San Sebastian, 20014, Spain

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Glascow, Scotland, G11 6NT, United Kingdom

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Fazakerley, Liverpool, L9 7LJ, United Kingdom

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York, Y031 8HE, United Kingdom

Location

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Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy, Complex Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2001
• Study Completion: February 1, 2006
• Last Updated: July 24, 2006

Record last verified: 2006-03

Locations

AU (4); CA (8); LI (2); IT (4); FR (9); GB (3); DE (11); ES (5)