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

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.
 
ClinicalTrials.gov Identifier: NCT01623622
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Upper Limb Hemiplegia Drug: HC-58 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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
Study Start Date : July 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
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


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

  2. 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

  3. 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 :
  1. Pain score by numeric rating scale [ Time Frame: 12 weeks ]
  2. Swelling asymmetry between hands [ Time Frame: 12 weeks ]
  3. Discolouration of the skin of the hand [ Time Frame: 12 weeks ]
  4. Difference in skin temperature between hands [ Time Frame: 12 weeks ]
  5. Decreased range of motion [ Time Frame: 12 weeks ]
  6. Radiographic finding of bone [ Time Frame: 12 weeks ]
  7. Bone metabolic marker [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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
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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
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Japan
Hamamatsu, Shizuoka, Japan
Fukui, Japan
Kumamoto, Kumamoto, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Investigators
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Study Director: Toshiya Umeda Asahi Kasei Pharma Corporation Clinical Development Center
More Information
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Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01623622    
Other Study ID Numbers: HC-58 (SHS) II-1
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2015
Additional relevant MeSH terms:
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Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases