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

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NCT00141245

Last updated on February 16, 2020

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About this Study

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

Study Location

Pfizer Investigational Site

Deakin, Australian Capital Territory, 2600 Australia

See other locations

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Partial Seizure Disorder

Sex

Females and Males

Age

18 + years

Inclusion criteria

Show details

- Must have met the inclusion criteria for preceding double-blind study

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

Exclusion criteria

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- Cannot have absence seizures

NCT00141245

Pfizer

Completed

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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Seizure Disorder, Partial

Intervention ^ICMJE

Drug: Pregabalin

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

325

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must have met the inclusion criteria for preceding double-blind study
Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

Cannot have absence seizures

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Austria, Belgium, Finland, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00141245

Other Study ID Numbers ^ICMJE

1008-012

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

December 2006

^ICMJE Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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

NCT00141245

About this Study

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Hot Topics

You are here

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

NCT00141245

About this Study

NEED INFO?

Try a new search

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