Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00437281
First received: February 16, 2007
Last updated: December 7, 2012
Last verified: December 2012
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Purpose
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsies, Partial |
Drug: Placebo Drug: Pregabalin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics 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; physical and neurologic exams;vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | April 2007 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
| Experimental: 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
Exclusion Criteria:
- Primary generalized seizures
- Progressive CNS pathology
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437281
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36693 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Gulf Breeze, Florida, United States, 32561 | |
| Pfizer Investigational Site | |
| Pensacola, Florida, United States, 32504 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33603 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33609 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65804 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14222 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 06720 | |
| Pfizer Investigational Site | |
| 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: | NCT00437281 History of Changes |
| Other Study ID Numbers: | A0081074 |
| Study First Received: | February 16, 2007 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics |
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 May 22, 2013