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

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)

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

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Drug: gabapentin

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gabapentin	Drug: gabapentin; Orally administered gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: A9451165