NCT01004016

Brief Summary

To evaluate the efficacy and safety of KPS-0373 in patients with SCD.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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

October 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

First QC Date

October 27, 2009

Last Update Submit

September 27, 2010

Conditions

Spinocerebellar Degeneration

Keywords

Spinocerebellar degenerationThyrotropin-Releasing Hormone (TRH)SCD

Outcome Measures

Primary Outcomes (2)

  • Scale for Assessment and Rating of Ataxia (SARA)

    4 weeks + 12 weeks

  • Upper and lower extremity function

    4 weeks + 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

KPS-0373

EXPERIMENTAL
Drug: KPS-0373

Interventions

KPS-0373DRUG
KPS-0373
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

Japan, 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

  • Yasuhiro Omori

    Clinical Development Department, Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 29, 2009

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

JP(1)