Trial record 2 of 2 for:
A9451162
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
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| ClinicalTrials.gov Identifier: NCT00603473 |
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Recruitment Status :
Completed
First Posted : January 29, 2008
Results First Posted : February 21, 2011
Last Update Posted : February 3, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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Brief Summary:
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsies, Partial | Drug: gabapentin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 92 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: gabapentin |
Drug: gabapentin
Orally administered gabapentin |
Primary Outcome Measures :
- Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 12 weeks ]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 ]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 ]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.
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| Ages Eligible for Study: | 3 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| ClinicalTrials.gov Identifier: | NCT00603473 |
| Other Study ID Numbers: |
A9451162 |
| First Posted: | January 29, 2008 Key Record Dates |
| Results First Posted: | February 21, 2011 |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | January 2011 |
Additional relevant MeSH terms:
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Seizures Epilepsies, Partial Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |