Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke
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ClinicalTrials.gov Identifier: NCT01623622 |
Recruitment Status :
Completed
First Posted : June 20, 2012
Last Update Posted : February 15, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Upper Limb Hemiplegia | Drug: HC-58 Drug: Placebo | Phase 2 |
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 |
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 |
- 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
- 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 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Hamamatsu, Shizuoka, Japan | |
Fukui, Japan | |
Kumamoto, Kumamoto, Japan |
Study Director: | Toshiya Umeda | Asahi Kasei Pharma Corporation Clinical Development Center |
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 |
Hemiplegia Paralysis Neurologic Manifestations Nervous System Diseases |