Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke

February 13, 2017 updated by: Asahi Kasei Pharma Corporation

A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan
      • Kumamoto, Kumamoto, Japan
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
once or more / week
Experimental: HC-58 low dose
Low dose
Drug: HC-58
once or more / week
Experimental: HC-58 high dose
High dose
Drug: HC-58
once or more / week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of shoulder hand syndrome
Time Frame: 12 weeks
The incidence rate of shoulder hand syndrome
12 weeks
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
Time Frame: 12 weeks
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
Time Frame: 12 weeks
FMA efficiency means FMA gain divided by period of administration
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain score by numeric rating scale
Time Frame: 12 weeks
12 weeks
Swelling asymmetry between hands
Time Frame: 12 weeks
12 weeks
Discolouration of the skin of the hand
Time Frame: 12 weeks
12 weeks
Difference in skin temperature between hands
Time Frame: 12 weeks
12 weeks
Decreased range of motion
Time Frame: 12 weeks
12 weeks
Radiographic finding of bone
Time Frame: 12 weeks
12 weeks
Bone metabolic marker
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Pharma Corporation

Investigators

  • Study Director: Toshiya Umeda, Asahi Kasei Pharma Corporation Clinical Development Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-58 (SHS) II-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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