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

Primary Purpose

Severe Upper Limb Hemiplegia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

HC-58

Placebo

About this trial

This is an interventional prevention trial for Severe Upper Limb Hemiplegia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

HC-58 low dose

HC-58 high dose

Placebo

Arm Description

Low dose

High dose

Outcomes

Primary Outcome Measures

Onset of shoulder hand syndrome

The incidence rate of shoulder hand syndrome

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

MBI efficiency means MBI gain divided by period of administration

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

FMA efficiency means FMA gain divided by period of administration

Secondary Outcome Measures

Pain score by numeric rating scale

Swelling asymmetry between hands

Discolouration of the skin of the hand

Difference in skin temperature between hands

Decreased range of motion

Radiographic finding of bone

Bone metabolic marker

Full Information

NCT ID

NCT01623622

First Posted

June 18, 2012

Last Updated

February 13, 2017

Sponsor

Asahi Kasei Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01623622

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asahi Kasei Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Upper Limb Hemiplegia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HC-58 low dose

Arm Type

Experimental

Arm Description

Low dose

Arm Title

HC-58 high dose

Arm Type

Experimental

Arm Description

High dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

HC-58

Intervention Description

once or more / week

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

once or more / week

Primary Outcome Measure Information:

Title

Onset of shoulder hand syndrome

Description

The incidence rate of shoulder hand syndrome

Time Frame

12 weeks

Title

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

Description

MBI efficiency means MBI gain divided by period of administration

Time Frame

12 weeks

Title

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

Description

FMA efficiency means FMA gain divided by period of administration

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Pain score by numeric rating scale

Time Frame

12 weeks

Title

Swelling asymmetry between hands

Time Frame

12 weeks

Title

Discolouration of the skin of the hand

Time Frame

12 weeks

Title

Difference in skin temperature between hands

Time Frame

12 weeks

Title

Decreased range of motion

Time Frame

12 weeks

Title

Radiographic finding of bone

Time Frame

12 weeks

Title

Bone metabolic marker

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toshiya Umeda

Organizational Affiliation

Asahi Kasei Pharma Corporation Clinical Development Center

Official's Role

Study Director

Facility Information:

City

Hamamatsu

State/Province

Shizuoka

Country

Japan

City

Fukui

Country

Japan

City

Kumamoto, Kumamoto

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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