NCT01623622

Brief Summary

The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

June 18, 2012

Last Update Submit

February 13, 2017

Conditions

Severe Upper Limb Hemiplegia

Outcome Measures

Primary Outcomes (3)

  • Onset of shoulder hand syndrome

    The incidence rate of shoulder hand syndrome

    12 weeks

  • Change from Baseline in the modified Barthel index (MBI) and MBI efficiency

    MBI efficiency means MBI gain divided by period of administration

    12 weeks

  • Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency

    FMA efficiency means FMA gain divided by period of administration

    12 weeks

Secondary Outcomes (7)

  • Pain score by numeric rating scale

    12 weeks

  • Swelling asymmetry between hands

    12 weeks

  • Discolouration of the skin of the hand

    12 weeks

  • Difference in skin temperature between hands

    12 weeks

  • Decreased range of motion

    12 weeks

  • +2 more secondary outcomes

Study Arms (3)

HC-58 low dose

EXPERIMENTAL

Low dose

Drug: HC-58

HC-58 high dose

EXPERIMENTAL

High dose

Drug: HC-58

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HC-58DRUG

once or more / week

HC-58 high doseHC-58 low dose
PlaceboDRUG

once or more / week

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with severe upper limb hemiplegia after stroke
  • Within 28 days after stroke at enrollment

You may not qualify if:

  • Patients with sensory loss between shoulder and hand on paralyzed side
  • Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Fukui-shi, Fukui, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Study Officials

  • Toshiya Umeda

    Asahi Kasei Pharma Corporation Clinical Development Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 15, 2017

Record last verified: 2015-02

Locations

JP(3)