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To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

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NCT00141414

Last updated on March 26, 2020
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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial 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 met the inclusion criteria for preceding double-blind study.

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

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

- Pregnant or considering becoming pregnant.

- Receiving any concomitant medication that could alter the effectiveness of their
medication response or seizure frequency.

NCT00141414
Pfizer
Completed
To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

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[email protected]

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Descriptive Information
Brief Title  ICMJE To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
Official Title  ICMJE Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.
Brief Summary To evaluate the long-term safety of pregabalin in refractory partial epilepsy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, 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
 (submitted: August 30, 2005) 		82
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 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:

  • Pregnant or considering becoming pregnant.
  • Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141414
Other Study ID Numbers  ICMJE 1008-008
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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