NCT01970111

Brief Summary

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

First QC Date

October 22, 2013

Last Update Submit

April 15, 2016

Conditions

Spinocerebellar Degeneration

Keywords

Spinocerebellar degeneration (SCD)Thyrotropin-Releasing Hormone (TRH)Spinocerebellar Ataxia (SCA)Cortical Cerebellar Atrophy (CCA)

Outcome Measures

Primary Outcomes (1)

  • SARA (Scale for the Assessment and Rating of Ataxia)

    52 weeks

Secondary Outcomes (1)

  • SF-8 (QOL)

    52 weeks

Study Arms (1)

KPS-0373

EXPERIMENTAL
Drug: KPS-0373, High doseDrug: KPS-0373, Low dose

Interventions

KPS-0373, High doseDRUG
KPS-0373
KPS-0373, Low doseDRUG
KPS-0373

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study)

You may not qualify if:

  • Less than 75% of compliance in KPS1301 study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo and Other Japanese Cities, Japan

Location

MeSH Terms

Conditions

Spinocerebellar DegenerationsSpinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebellar AtaxiaAtaxiaDyskinesiasNeurologic Manifestations

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Primary Completion

July 1, 2015

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

JP(1)