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

NCT00448916

Last updated date
Study Location
University of South Alabama
Mobile, Alabama, 36604, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
Official Title  ICMJE A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Brief Summary 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.
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 Epilepsies, Partial
Intervention  ICMJE Drug: Pregabalin
Orally-administered pregabalin
Study Arms  ICMJE Experimental: Pregabalin
Orally-administered pregabalin
Intervention: Drug: Pregabalin
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
Actual Enrollment  ICMJE
 (submitted: November 13, 2013)
54
Original Enrollment  ICMJE
 (submitted: March 15, 2007)
60
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Mexico,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00448916
Other Study ID Numbers  ICMJE A0081075
2010-020731-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP