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

NCT ID: NCT01623622

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Severe Upper Limb Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HC-58 low dose

Low dose

Group Type EXPERIMENTAL

HC-58

Intervention Type DRUG

once or more / week

HC-58 high dose

High dose

Group Type EXPERIMENTAL

HC-58

Intervention Type DRUG

once or more / week

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once or more / week

Interventions

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HC-58

once or more / week

Intervention Type DRUG

Placebo

once or more / week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asahi Kasei Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshiya Umeda

Role: STUDY_DIRECTOR

Asahi Kasei Pharma Corporation Clinical Development Center

Locations

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Fukui-shi, Fukui, Japan

Site Status

Hamamatsu, Shizuoka, Japan

Site Status

Kumamoto, Kumamoto, , Japan

Site Status

Countries

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Japan

Other Identifiers

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HC-58 (SHS) II-1

Identifier Type: -

Identifier Source: org_study_id

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