Trial record 1 of 1 for:
A9451165
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00620555 |
|
Recruitment Status :
Completed
First Posted : February 21, 2008
Results First Posted : December 20, 2011
Last Update Posted : February 3, 2021
|
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. )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
Examine the safety and efficacy 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 : | 65 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473) |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: gabapentin |
Drug: gabapentin
Orally administered gabapentin |
Primary Outcome Measures :
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [ Time Frame: up to 53 weeks ]Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Secondary Outcome Measures :
- Response Ratio [ Time Frame: Up to 52 weeks ]The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus 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 52-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 of the previous study A9451162 (NCT00603473).
- Responder Rate [ Time Frame: Up to 52 weeks ]Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).
- Percent Change in Seizure Frequency [ Time Frame: Up to 52 weeks ]Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by 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 52-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 of the previous study A9451162 (NCT00603473).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of study A9451162 (NCT00603473)
Exclusion Criteria:
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
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): NCT00620555
Locations
| Japan | |
| Pfizer Investigational Site | |
| Obu-shi,Morioka-machi, Aichi, Japan | |
| Pfizer Investigational Site | |
| Jonan-ku, Fukuoka, 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 | |
| Shizuoka-shi, Shizuoka, 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 | |
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: | NCT00620555 |
| Other Study ID Numbers: |
A9451165 |
| First Posted: | February 21, 2008 Key Record Dates |
| Results First Posted: | December 20, 2011 |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | November 2011 |
Additional relevant MeSH terms:
|
Epilepsies, Partial Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases 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 |