Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
NCT00448916
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Partial onset seizures, incompletely controlled on 1-3 medications
- At least 1 seizure per 28 days, on average
- Completion of study A0081074
- Primary generalized seizures
- Progressive CNS pathology
- Failure to tolerate pregabalin in study A0081074
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Obu-shi,Morioka-machi, Aichi
- Jonan-ku, Fukuoka
- Kobe, Hyogo
- Suma-Ku,Kobe, Hyogo
- Kanazawa, Ishikawa
- Zentsuuji, Kagawa
- Yokohama, Kanagawa Pref.
- Sendai-shi, Miyagi-ken
- Showa-Ku, Nagoya
- Niigata-shi, Niigata
- Kurashiki-City, Okayama Pref.
- Okayama-shi, Okayama
- Izumi-shi, Osaka
- Miyakojima-ku, Osaka
- Suita, Osaka
- Shizuoka-shi, Shizuoka
- Kodaira, Tokyo
- Setagaya-ku, Tokyo
- Shinjuku-ku, Tokyo
- Hiroshima,
- Saitama,
- Yamagata,
- Mobile, Alabama
- Mobile, Alabama
- Phoenix, Arizona
- Jonesboro, Arkansas
- Little Rock, Arkansas
- San Francisco, California
- Gulf Breeze, Florida
- Pensacola, Florida
- Tampa, Florida
- Tampa, Florida
- Springfield, Missouri
- Buffalo, New York
- Durham, North Carolina
- Houston, Texas
- San Antonio, Texas
- Seoul,
- Mexico, DF
- Guadalajara, Jalisco
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 | 54 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |