NCT00141245

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 1998

Longer than P75 for phase_3

Geographic Reach
12 countries

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

January 1, 2007

Status Verified

December 1, 2006

First QC Date

August 30, 2005

Last Update Submit

December 28, 2006

Conditions

Seizure Disorder, Partial

Outcome Measures

Primary Outcomes (1)

  • Safety Efficacy

Interventions

PregabalinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 have absence seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Pfizer Investigational Site

Deakin, Australian Capital Territory, 2600, Australia

Location

Pfizer Investigational Site

Chatswood, New South Wales, 2067, Australia

Location

Pfizer Investigational Site

Westmead, New South Wales, 2145, Australia

Location

Pfizer Investigational Site

Maroochydore, Queensland, 4558, Australia

Location

Pfizer Investigational Site

Heidelberg, VIC 3084, Australia

Location

Pfizer Investigational Site

Woodville, 5011, Australia

Location

Pfizer Investigational Site

Graz, A-8035, Austria

Location

Pfizer Investigational Site

Innsbruck, A-6020, Austria

Location

Pfizer Investigational Site

Duffel, 2570, Belgium

Location

Pfizer Investigational Site

Helsinki, 00029, Finland

Location

Pfizer Investigational Site

Turku, FIN-20521, Finland

Location

Pfizer Investigational Site

Lyon, Cedex, 69694, France

Location

Pfizer Investigational Site

Paris, Cedex, 75674, France

Location

Pfizer Investigational Site

Tours, Cedex, 37044, France

Location

Pfizer Investigational Site

Dijon, 21000, France

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Roubaix, 59100, France

Location

Pfizer Investigational Site

Erlangen, 91054, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Göttingen, D-37075, Germany

Location

Pfizer Investigational Site

Hamburg, 22292, Germany

Location

Pfizer Investigational Site

Mainz, 55131, Germany

Location

Pfizer Investigational Site

Mönchengladbach, 41179, Germany

Location

Pfizer Investigational Site

Munich, D-81377, Germany

Location

Pfizer Investigational Site

Münster, 48149, Germany

Location

Pfizer Investigational Site

Florence, 50135, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Perugia, 06123, Italy

Location

Pfizer Investigational Site

Pisa, 56126, Italy

Location

Pfizer Investigational Site

Heemstede, 2103 SW, Netherlands

Location

Pfizer Investigational Site

Heeze, 5591 VE, Netherlands

Location

Pfizer Investigational Site

Parow, Cape Town, 7505, South Africa

Location

Pfizer Investigational Site

Durban, 4052, South Africa

Location

Pfizer Investigational Site

Girona, Gerona, 17007, Spain

Location

Pfizer Investigational Site

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Gothenburg, S-413 45, Sweden

Location

Pfizer Investigational Site

Lavigny, LE, CN-1775, Switzerland

Location

Pfizer Investigational Site

Tschugg, CH-3233, Switzerland

Location

Pfizer Investigational Site

Bimingham, B15 2QZ, United Kingdom

Location

Pfizer Investigational Site

Bucks, SL9 ORJ, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD1 9ND, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L9 1AE, United Kingdom

Location

Pfizer Investigational Site

York, Y03 7HE, United Kingdom

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino 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 1, 2005

Study Start

October 1, 1998

Study Completion

November 1, 2005

Last Updated

January 1, 2007

Record last verified: 2006-12

Locations

CH(2)GB(6)FR(6)IT(4)AU(6)FI(2)BE(1)ZA(2)ES(4)SE(1)DE(8)NL(2)