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NCT00603473 Clinical Trial

A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Epilepsies, Partial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00603473
Other study ID # A9451162
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2008
Est. completion date December 2009

Study information
Verified date January 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 3 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• gabapentin
Orally administered gabapentin

Locations
Country Name City State
Japan Pfizer Investigational Site Higashimatsuyama Saitama
Japan Pfizer Investigational Site Hiroshima
Japan Pfizer Investigational Site Izumi-shi Osaka
Japan Pfizer Investigational Site Jonan-ku Fukuoka
Japan Pfizer Investigational Site Kanazawa Ishikawa
Japan Pfizer Investigational Site Kiyose-shi Tokyo
Japan Pfizer Investigational Site Kobe Hyogo
Japan Pfizer Investigational Site Kodaira Tokyo
Japan Pfizer Investigational Site Kurashiki-City Okayama Pref.
Japan Pfizer Investigational Site Miyakojima-ku Osaka
Japan Pfizer Investigational Site Niigata-shi Niigata
Japan Pfizer Investigational Site Obu-shi,Morioka-machi Aichi
Japan Pfizer Investigational Site Okayama-shi Okayama
Japan Pfizer Investigational Site Saitama
Japan Pfizer Investigational Site Sapporo Hokkaido
Japan Pfizer Investigational Site Sendai-shi Miyagi-ken
Japan Pfizer Investigational Site Setagaya-ku Tokyo
Japan Pfizer Investigational Site Shinjuku-ku Tokyo
Japan Pfizer Investigational Site Shizuoka-shi Shizuoka
Japan Pfizer Investigational Site Showa-Ku Nagoya
Japan Pfizer Investigational Site Suita Osaka
Japan Pfizer Investigational Site Suma-Ku, Kobe Hyogo
Japan Pfizer Investigational Site Yamagata
Japan Pfizer Investigational Site Yamanashi
Japan Pfizer Investigational Site Yokohama Kanagawa Pref.
Japan Pfizer Investigational Site Zentsuuji Kagawa

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures 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. 12 weeks
Secondary Responder Rate 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. 12 weeks
Secondary Percent Change in Seizure Frequency (PCH) 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. 12 weeks
See also
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Completed NCT00772603 - Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures Phase 3
Completed NCT00280696 - A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures Phase 3
Completed NCT00643136 - A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures Phase 3
Completed NCT00230698 - A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure Phase 3
Completed NCT00072813 - MRI in Autosomal Dominant Partial Epilepsy With Auditory Features N/A
Enrolling by invitation NCT04309812 - Transcranial Direct Current to Treat Epilepsy at Home Early Phase 1
Withdrawn NCT00422110 - A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures Phase 2/Phase 3
Completed NCT00620555 - A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures Phase 3
Completed NCT00448916 - Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures Phase 3
Completed NCT00210522 - An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy Phase 2
Completed NCT00236886 - Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients Phase 3
Completed NCT00236860 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures Phase 2
Active, not recruiting NCT03689114 - Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) Phase 4
Completed NCT01098162 - Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug N/A
Completed NCT05273398 - Effects of Diazepam on RNS Detections Phase 4

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