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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

Tracking Information
First Submitted Date  ICMJE June 18, 2012
First Posted Date  ICMJE June 20, 2012
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01623622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke
Official Title  ICMJE A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Severe Upper Limb Hemiplegia
Intervention  ICMJE
  • Drug: HC-58
    once or more / week
  • Drug: Placebo
    once or more / week
Study Arms
  • Experimental: HC-58 low dose
    Low dose
    Intervention: Drug: HC-58
  • Experimental: HC-58 high dose
    High dose
    Intervention: Drug: HC-58
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 18, 2012)
270
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01623622
Other Study ID Numbers  ICMJE HC-58 (SHS) II-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Asahi Kasei Pharma Corporation
Study Sponsor  ICMJE Asahi Kasei Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Toshiya Umeda Asahi Kasei Pharma Corporation Clinical Development Center
PRS Account Asahi Kasei Pharma Corporation
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP