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

This study has been completed.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation Identifier:
First received: June 18, 2012
Last updated: February 13, 2017
Last verified: February 2015
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.

Condition Intervention Phase
Severe Upper Limb Hemiplegia
Drug: HC-58
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke

Resource links provided by NLM:

Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • Onset of shoulder hand syndrome [ Time Frame: 12 weeks ]
    The incidence rate of shoulder hand syndrome

  • 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

  • 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

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

Estimated Enrollment: 270
Study Start Date: July 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
once or more / week


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01623622

Hamamatsu, Shizuoka, Japan
Fukui, Japan
Kumamoto, Kumamoto, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Study Director: Toshiya Umeda Asahi Kasei Pharma Corporation Clinical Development Center
  More Information

Responsible Party: Asahi Kasei Pharma Corporation Identifier: NCT01623622     History of Changes
Other Study ID Numbers: HC-58 (SHS) II-1
Study First Received: June 18, 2012
Last Updated: February 13, 2017

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017