NCT00975715

Brief Summary

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

25 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

Study Start

First participant enrolled

September 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 24, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

3.1 years

First QC Date

September 10, 2009

Results QC Date

October 8, 2013

Last Update Submit

July 9, 2014

Conditions

Partial Onset Seizures

Keywords

Seizuresoxcarbazepinechild

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group

    Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.

    screening and 28 days

Secondary Outcomes (4)

  • Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group

    baseline, 28 days and 56 days

  • Percent of Participants With Response During Double-blind Phase, by Treatment Group

    screening to 28 days

  • Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type

    28 days

  • Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group

    56 days

Study Arms (2)

TRI476

EXPERIMENTAL

Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.

Drug: TRI476Drug: Benzodiazepines

Placebo

PLACEBO COMPARATOR

Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Drug: Placebo to TRI476Drug: Benzodiazepines

Interventions

TRI476DRUG

TRI476 oral suspension doses, based on body weight twice daily

TRI476
Placebo to TRI476DRUG

Placebo oral suspension, taken twice daily

Placebo
BenzodiazepinesDRUG

Benzodiazepines could be used as needed as rescue medication during the duration of the study.

PlaceboTRI476

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
  • A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).

You may not qualify if:

  • A document history of generalized status epileptics in the past 6 months.
  • Seizures having a metabolic, neoplastic, or active infectious origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Novartis Investigative Site

Nagoya, Aichi-ken, 460-0004, Japan

Location

Novartis Investigative Site

Ohbu, Aichi-ken, 474-0031, Japan

Location

Novartis Investigative Site

Matsuyama, Ehime, 790-8524, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Novartis Investigative Site

Gifu, Gifu, 502-8558, Japan

Location

Novartis Investigative Site

Kameda-gun, Hokkaido, 041-1111, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Himeji, Hyōgo, 670-8540, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 658-0032, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 244-0842, Japan

Location

Novartis Investigative Site

Kōshi, Kumamoto, 861-1196, Japan

Location

Novartis Investigative Site

Kashiwazaki, Niigata, 945-8585, Japan

Location

Novartis Investigative Site

Niigata, Niigata, 950-2085, Japan

Location

Novartis Investigative Site

Yufu, Oita Prefecture, 879-5593, Japan

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 710-8522, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Neyagawa, Osaka, 572-0085, Japan

Location

Novartis Investigative Site

Higashimatsuyama-shi, Saitama, 355-0008, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 339-8551, Japan

Location

Novartis Investigative Site

Moriyama-shi, Shiga, 524-0022, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 420-8688, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Yamagata, Yamagata, 990-0876, Japan

Location

Novartis Investigative Site

Chūō, Yamanashi, 409-3898, Japan

Location

Related Links

MeSH Terms

Conditions

Seizures

Interventions

Benzodiazepines

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis
41 61 324 1111

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 16, 2014

Results First Posted

January 24, 2014

Record last verified: 2014-07

Locations

JP(25)