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Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

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NCT00448916

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
University of South Alabama
Mobile, Alabama, 36604 United States
See other locations
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 Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-16 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Partial onset seizures, incompletely controlled on 1-3 medications

- At least 1 seizure per 28 days, on average

- Completion of study A0081074

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

- Primary generalized seizures

- Progressive CNS pathology

- Failure to tolerate pregabalin in study A0081074

NCT00448916
Pfizer
Completed
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

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Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsies, Partial
Drug: Pregabalin
Orally-administered pregabalin
Experimental: Pregabalin
Orally-administered pregabalin
Intervention: Drug: Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Partial onset seizures, incompletely controlled on 1-3 medications
  • At least 1 seizure per 28 days, on average
  • Completion of study A0081074

Exclusion Criteria:

  • Primary generalized seizures
  • Progressive CNS pathology
  • Failure to tolerate pregabalin in study A0081074
Sexes Eligible for Study: All
1 Month to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Mexico,   United States
France
 
NCT00448916
A0081075
2010-020731-39 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

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

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