Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

NCT00150293 | Completed Phase 3

• 1 other identifier: 1008-114
• Study Type: interventional
• Target: 337
• Locations: 9 countries
• Sites: 74

Brief Summary

To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Conditions

Seizure Disorder, Partial

Outcome Measures

Primary Outcomes (1)

• Safety Efficacy

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 received double-blind study medication and wish to receive open-label pregabalin.

You may not qualify if:

• Cannot be pregnant or considering becoming pregnant during the course of the study.
• Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (83)

Pfizer Investigational Site

Deakin, Australian Capital Territory, 2600, Australia

Location

Pfizer Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Pfizer Investigational Site

Chastwood, New South Wales, 2067, Australia

Location

Pfizer Investigational Site

Cairns, Queensland, 4870, Australia

Location

Pfizer Investigational Site

Maroochydore, Queensland, 4558, Australia

Location

Pfizer Investigational Site

Footscray, Victoria, 3011, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3050, Australia

Location

Pfizer Investigational Site

Perth, Western Australia, 6001, Australia

Location

Pfizer Investigational Site

Auenbruggerplatz 22, A-8035 GRAZ, Austria

Location

Pfizer Investigational Site

Graz, 8020, Austria

Location

Pfizer Investigational Site

Innsbruck, A6020, Austria

Location

Pfizer Investigational Site

Linz, 4020, Austria

Location

Pfizer Investigational Site

Vienna, 1220, Austria

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Calgary, Alberta, T2N 2T9, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T5G 0B7, Canada

Location

Pfizer Investigational Site

Penticton, British Columbia, V2A 4V8, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Pfizer Investigational Site

Barrie, Ontario, L4M 4S5, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 5A5, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1L 8L6, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5T 2S8, Canada

Location

Pfizer Investigational Site

Windsor, Ontario, N8X5A6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 2B4, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1J 1Z4, Canada

Location

Pfizer Investigational Site

Regina, Saskatchewan, S4T 1A5, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Pfizer Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Pfizer Investigational Site

Berlin, BE10362, Germany

Location

Pfizer Investigational Site

Bernau, 16321, Germany

Location

Pfizer Investigational Site

Bonn, 53127, Germany

Location

Pfizer Investigational Site

Dresden, 01307, Germany

Location

Pfizer Investigational Site

Erlangen, 91054, Germany

Location

Pfizer Investigational Site

Essen, 45147, Germany

Location

Pfizer Investigational Site

Frankfurt, HE 60528, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Göttingen, D-37075, Germany

Location

Pfizer Investigational Site

Hamburg, D-22337, Germany

Location

Pfizer Investigational Site

Mainz, 55101, Germany

Location

Pfizer Investigational Site

München, 81377, Germany

Location

Pfizer Investigational Site

AE Breda, 4836, Netherlands

Location

Pfizer Investigational Site

Blaricum, 1261 AN, Netherlands

Location

Pfizer Investigational Site

Ve Heeze, 5591, Netherlands

Location

Pfizer Investigational Site

Bialystok, 15-276, Poland

Location

Pfizer Investigational Site

Bydgoszcz, 85-826, Poland

Location

Pfizer Investigational Site

Choroszcz, 16-070, Poland

Location

Pfizer Investigational Site

Gdansk, 80-211, Poland

Location

Pfizer Investigational Site

Gdansk, 82-803, Poland

Location

Pfizer Investigational Site

Grudziądz, 86-300, Poland

Location

Pfizer Investigational Site

Katowice, 46-645, Poland

Location

Pfizer Investigational Site

Krakow, 31-112, Poland

Location

Pfizer Investigational Site

Lublin, 20-718, Poland

Location

Pfizer Investigational Site

Mosina, 62-050, Poland

Location

Pfizer Investigational Site

Olsztyn, 10-561, Poland

Location

Pfizer Investigational Site

Poznan, 60-780, Poland

Location

Pfizer Investigational Site

Poznan, 61-285, Poland

Location

Pfizer Investigational Site

Płock, 09-402, Poland

Location

Pfizer Investigational Site

Torun, 87-100, Poland

Location

Pfizer Investigational Site

Warsaw, 00-909, Poland

Location

Pfizer Investigational Site

Warsaw, 02-957, Poland

Location

Pfizer Investigational Site

Warsaw, Poland

Location

Pfizer Investigational Site

Coimbra, 3000-075, Portugal

Location

Pfizer Investigational Site

Porto, 4099, Portugal

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Granada, Granada, 18013, Spain

Location

Pfizer Investigational Site

Málaga, Malaga, 29010, Spain

Location

Pfizer Investigational Site

Zaragoza, Zaragoza, 50009, Spain

Location

Pfizer Investigational Site

Girona, 17007, Spain

Location

Pfizer Investigational Site

Madrid, 28034, Spain

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Middlesbrough, N. York, TS5 5AZ, United Kingdom

Location

Pfizer Investigational Site

Washington, Tyne & Wear, NE38 9JZ, United Kingdom

Location

Pfizer Investigational Site

Blackpool, FY3 8BP, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

London, E1 1BB, United Kingdom

Location

Pfizer Investigational Site

Northampton, NN1 5BD, United Kingdom

Location

Pfizer Investigational Site

Wolverhampton, WV10 0QP, United Kingdom

Location

Pfizer Investigational Site

Location

MeSH Terms

Conditions

Epilepsies, 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: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2002
• Study Completion: November 1, 2005
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

PL (18); BE (1); AU (5); CA (16); PT (2); ES (7); DE (13); NL (3); GB (9)