NCT01970098

Brief Summary

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

October 9, 2013

Completed
13 days until next milestone

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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

October 22, 2013

Last Update Submit

December 12, 2018

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)

    The change in the SARA total score at the time of final evaluation

    24 weeks

Secondary Outcomes (1)

  • SF-8 (QOL)

    24 weeks

Study Arms (2)

KPS-0373

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

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KPS-0373, High doseDRUG

28 weeks

KPS-0373
KPS-0373, Low doseDRUG

28 weeks

KPS-0373
PlaceboDRUG

28 weeks

Placebo

Eligibility Criteria

Age20 Years+
Sexall
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)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

  • Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.

    PMID: 31937586DERIVED

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 Officials

  • Tatsuro Takei

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

October 9, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations

JP(1)