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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

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: 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
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 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 August 28, 2014