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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623622
First Posted: June 20, 2012
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
  Purpose
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: Double (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623622


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

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01623622     History of Changes
Other Study ID Numbers: HC-58 (SHS) II-1
First Submitted: June 18, 2012
First Posted: June 20, 2012
Last Update Posted: February 15, 2017
Last Verified: February 2015

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms