NCT00863538

Brief Summary

To evaluate the efficacy, safety and pharmacokinetics profile 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
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

First QC Date

March 16, 2009

Last Update Submit

February 1, 2010

Conditions

Spinocerebellar Degeneration

Keywords

Spinocerebellar degenerationThyrotropin-Releasing Hormone (TRH)SCD

Outcome Measures

Primary Outcomes (1)

  • Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression

    12 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: KPS-0373

Interventions

KPS-0373DRUG
1

Eligibility Criteria

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

You may qualify if:

  • SCD 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 (3)

Japan

Hokkaido Region, Japan

Location

Japan

Kansai Region, Japan

Location

Japan

Kanto Region, 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

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 18, 2009

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

JP(3)