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An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164
and wishes to continue receiving open-label pregabalin

- Must have responded favorably to pregabalin in Pfizer open-label study 1008-010,
1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator
continued treatment with pregabalin is in the the patient's best medical interest

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Is pregnant or is considering becoming pregnant during the course of the study

- Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035,
1008-114 or 1008-164

NCT00372528
Pfizer
Terminated
An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

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An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
Drug: pregabalin (LYRICA)
150 mg up to a maximum of 600 mg per day bid or tid as required
Experimental: pregabalin
open label treatment
Intervention: Drug: pregabalin (LYRICA)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
  • Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Exclusion Criteria:

  • Is pregnant or is considering becoming pregnant during the course of the study
  • Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00372528
A0081140
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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