NCT00620555

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2011

Completed
Last Updated

February 3, 2021

Status Verified

November 1, 2011

Enrollment Period

2.6 years

First QC Date

February 11, 2008

Results QC Date

November 14, 2011

Last Update Submit

February 1, 2021

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Response Ratio

    Up to 52 weeks

  • Responder Rate

    Up to 52 weeks

  • Percent Change in Seizure Frequency

    Up to 52 weeks

Study Arms (1)

gabapentin

EXPERIMENTAL
Drug: gabapentin

Interventions

gabapentinDRUG

Orally administered gabapentin

gabapentin

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of study A9451162 (NCT00603473)

You may not qualify if:

  • Seizures related to drugs or acute medical illness
  • History of any serious medical or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Jonan-ku, Fukuoka, 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

Shizuoka, Shizuoka, 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

Related Links

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino 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

February 11, 2008

First Posted

February 21, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 3, 2021

Results First Posted

December 20, 2011

Record last verified: 2011-11

Locations

JP(22)