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

This study is currently recruiting participants.
Verified July 2012 by Asahi Kasei Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01623622
First received: June 18, 2012
Last updated: July 8, 2012
Last verified: July 2012
History of Changes
  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
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

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: December 2014 (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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623622

Contacts
Contact: Toshiya Umeda umeda.tc@om.asahi-kasei.co.jp

Locations
Japan
Not yet recruiting
Hamamatsu, Shizuoka, Japan
Not yet recruiting
Fukui, Japan
Recruiting
Kumamoto, Kumamoto, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
Investigators
Study Director: Toshiya Umeda Asahi Kasei Pharma Corporation Clinical Development Center
  More Information

No publications provided

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01623622     History of Changes
Other Study ID Numbers: HC-58 (SHS) II-1
Study First Received: June 18, 2012
Last Updated: July 8, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013