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

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

Examine the efficacy, safety and pharmacokinetics 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): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • Pfizer Investigational Site
  • Saitama, Japan
    • Pfizer Investigational Site
  • Yamagata, Japan
    • Pfizer Investigational Site
  • Yamanashi, Japan
    • Pfizer Investigational Site
  • Aichi
    • Obu-shi,Morioka-machi, Aichi, Japan
      • Pfizer Investigational Site
  • Fukuoka
    • Jonan-ku, Fukuoka, Japan
      • Pfizer Investigational Site
  • Hokkaido
    • Sapporo, Hokkaido, 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
  • Saitama
    • Higashimatsuyama, Saitama, Japan
      • Pfizer Investigational Site
  • Shizuoka
    • Shizuoka-shi, Shizuoka, Japan
      • Pfizer Investigational Site
  • Tokyo
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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: January 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 16, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimate): January 29, 2008

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; 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: A9451162