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

NCT00603473 | Completed Phase 3 Results

• 1 other identifier: A9451162
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Rate

  12 weeks

• Percent Change in Seizure Frequency (PCH)

  12 weeks

Study Arms (1)

gabapentin

EXPERIMENTAL

Drug: gabapentin

Interventions

gabapentin DRUG

Orally administered gabapentin

gabapentin

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (26)

Pfizer Investigational Site

Obu-shi,Morioka-machi, Aichi-ken, Japan

Location

Pfizer Investigational Site

Jonan-ku, Fukuoka, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Location

Pfizer Investigational Site

Suma-Ku, Kobe, Hyōgo, Japan

Location

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Location

Pfizer Investigational Site

Zentsuuji, Kagawa-ken, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa Pref., Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Shōwaku, Nagoya, Japan

Location

Pfizer Investigational Site

Niigata, Niigata, Japan

Location

Pfizer Investigational Site

Kurashiki, Okayama Pref., Japan

Location

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Location

Pfizer Investigational Site

Izumi-shi, Osaka, Japan

Location

Pfizer Investigational Site

Miyakojima-ku, Osaka, Japan

Location

Pfizer Investigational Site

Suita, Osaka, Japan

Location

Pfizer Investigational Site

Higashi-Matsuyama, Saitama, Japan

Location

Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

Location

Pfizer Investigational Site

Kiyose-shi, Tokyo, Japan

Location

Pfizer Investigational Site

Kodaira, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Hiroshima, Japan

Location

Pfizer Investigational Site

Saitama, Japan

Location

Pfizer Investigational Site

Yamagata, Japan

Location

Pfizer Investigational Site

Yamanashi, Japan

Location

Related Links

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

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 3, 2021
• Results First Posted: February 21, 2011

Record last verified: 2011-01

Locations

JP (26)