NCT01384435

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

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

June 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
Last Updated

December 3, 2012

Status Verified

March 1, 2012

First QC Date

June 23, 2011

Last Update Submit

November 29, 2012

Conditions

SCD

Keywords

Spinocerebellar degeneration (SCD)Thyrotropin-Releasing Hormone (TRH)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Scale for the assessment and rating of ataxia (SARA)

    24 weeks

Secondary Outcomes (1)

  • Change from baseline in patient improvement impression of activities of daily living

    24 weeks

Study Arms (5)

KPS-0373, lowest dose

EXPERIMENTAL
Drug: KPS-0373

KPS-0373, 2nd lowest dose

EXPERIMENTAL
Drug: KPS-0373

KPS-0373, 2nd highest dose

EXPERIMENTAL
Drug: KPS-0373

KPS-0373, highest dose

EXPERIMENTAL
Drug: KPS-0373

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KPS-0373DRUG
KPS-0373, lowest dose
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Japanese SCD patients with mild to moderate ataxia

You may not qualify if:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Spinocerebellar Degenerations

Condition Hierarchy (Ancestors)

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

Study Officials

  • Katsumi Hontani

    Clinical Research Dept.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 29, 2011

Last Updated

December 3, 2012

Record last verified: 2012-03

Locations

JP(1)