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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation Identifier:
First received: June 18, 2012
Last updated: February 3, 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    The incidence rate of shoulder hand syndrome

  • Change from Baseline in the modified Barthel index (MBI) and MBI efficiency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    FMA efficiency means FMA gain divided by period of administration

Secondary Outcome Measures:
  • Pain score by numeric rating scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Swelling asymmetry between hands [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Discolouration of the skin of the hand [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Difference in skin temperature between hands [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Decreased range of motion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Radiographic finding of bone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bone metabolic marker [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: July 2012
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 3, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 26, 2016