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

Epilepsies, Partial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620555
• Other study ID #: A9451165
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial

Intervention

Drug:
• gabapentin
Orally administered gabapentin

Locations

Country	Name	City	State
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	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	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	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	Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)	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.	up to 53 weeks
Secondary	Response Ratio	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).	Up to 52 weeks
Secondary	Responder Rate	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).	Up to 52 weeks
Secondary	Percent Change in Seizure Frequency	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).	Up to 52 weeks

External Links

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