A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00603473
First received: January 16, 2008
Last updated: January 24, 2011
Last verified: January 2011
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Purpose
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsies, Partial |
Drug: gabapentin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.
Secondary Outcome Measures:
- Responder Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.
- Percent Change in Seizure Frequency (PCH) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.
| Enrollment: | 92 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: gabapentin |
Drug: gabapentin
Orally administered gabapentin
|
Eligibility| Ages Eligible for Study: | 3 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
- Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
- Have not been able to achieve adequate seizure control with antiepileptic drugs
Exclusion Criteria:
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
- Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603473
Locations
| Japan | |
| Pfizer Investigational Site | |
| Obu-shi,Morioka-machi, Aichi, Japan | |
| Pfizer Investigational Site | |
| Jonan-ku, Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Kobe, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Suma-Ku, Kobe, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Kanazawa, Ishikawa, Japan | |
| Pfizer Investigational Site | |
| Zentsuuji, Kagawa, Japan | |
| Pfizer Investigational Site | |
| Yokohama, Kanagawa Pref., Japan | |
| Pfizer Investigational Site | |
| Sendai-shi, Miyagi-ken, Japan | |
| Pfizer Investigational Site | |
| Showa-Ku, Nagoya, Japan | |
| Pfizer Investigational Site | |
| Niigata-shi, Niigata, Japan | |
| Pfizer Investigational Site | |
| Kurashiki-City, Okayama Pref., Japan | |
| Pfizer Investigational Site | |
| Okayama-shi, Okayama, Japan | |
| Pfizer Investigational Site | |
| Izumi-shi, Osaka, Japan | |
| Pfizer Investigational Site | |
| Miyakojima-ku, Osaka, Japan | |
| Pfizer Investigational Site | |
| Suita, Osaka, Japan | |
| Pfizer Investigational Site | |
| Higashimatsuyama, Saitama, Japan | |
| Pfizer Investigational Site | |
| Shizuoka-shi, Shizuoka, Japan | |
| Pfizer Investigational Site | |
| Kiyose-shi, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Kodaira, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Setagaya-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shinjuku-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Hiroshima, Japan | |
| Pfizer Investigational Site | |
| Saitama, Japan | |
| Pfizer Investigational Site | |
| Yamagata, Japan | |
| Pfizer Investigational Site | |
| Yamanashi, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00603473 History of Changes |
| Other Study ID Numbers: | A9451162 |
| Study First Received: | January 16, 2008 |
| Results First Received: | December 6, 2010 |
| Last Updated: | January 24, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 23, 2013