Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00448916
First received: March 15, 2007
Last updated: May 30, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsies, Partial |
Drug: Pregabalin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 12-Month Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Frequency and severity of adverse events, which will be evaluated at every visit throughout the 12 month study period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Physical and neurologic exams, vital signs, growth parameters, ECGs, laboratory tests, and seizure frequency, all of which will be evaluated throughout the 12 month study period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pregabalin
Orally-administered pregabalin
|
Drug: Pregabalin
Orally-administered pregabalin
|
Eligibility| Ages Eligible for Study: | 1 Month to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448916
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, Alabama | |
| Pfizer Investigational Site | Completed |
| Mobile, Alabama, United States, 36693 | |
| Pfizer Investigational Site | Completed |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Pfizer Investigational Site | Completed |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Pfizer Investigational Site | Terminated |
| Jonesboro, Arkansas, United States, 72401 | |
| Pfizer Investigational Site | Terminated |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Pfizer Investigational Site | Recruiting |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Pfizer Investigational Site | Completed |
| Gulf Breeze, Florida, United States, 32561 | |
| Pfizer Investigational Site | Recruiting |
| Tampa, Florida, United States, 33603 | |
| Pfizer Investigational Site | Recruiting |
| Tampa, Florida, United States, 33609 | |
| United States, Missouri | |
| Pfizer Investigational Site | Completed |
| Springfield, Missouri, United States, 65804 | |
| United States, New York | |
| Pfizer Investigational Site | Completed |
| Buffalo, New York, United States, 14222 | |
| United States, North Carolina | |
| Pfizer Investigational Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| Pfizer Investigational Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78258 | |
| Korea, Republic of | |
| Pfizer Investigational Site | Completed |
| Seoul, Korea, Republic of, 120-752 | |
| Mexico | |
| Pfizer Investigational Site | Not yet recruiting |
| Mexico, DF, Mexico, 04530 | |
| Pfizer Investigational Site | Recruiting |
| Guadalajara, Jalisco, Mexico, 44280 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00448916 History of Changes |
| Other Study ID Numbers: | A0081075 |
| Study First Received: | March 15, 2007 |
| Last Updated: | May 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013