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

Severe Upper Limb Hemiplegia Clinical Trial

Official title:

A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623622
• Other study ID #: HC-58 (SHS) II-1
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2012
• Last updated: February 13, 2017
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: February 2015
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Severe Upper Limb Hemiplegia

Intervention

Drug:
• HC-58
once or more / week
• Placebo
once or more / week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of shoulder hand syndrome	The incidence rate of shoulder hand syndrome	12 weeks
Primary	Change from Baseline in the modified Barthel index (MBI) and MBI efficiency	MBI efficiency means MBI gain divided by period of administration	12 weeks
Primary	Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency	FMA efficiency means FMA gain divided by period of administration	12 weeks
Secondary	Pain score by numeric rating scale		12 weeks
Secondary	Swelling asymmetry between hands		12 weeks
Secondary	Discolouration of the skin of the hand		12 weeks
Secondary	Difference in skin temperature between hands		12 weeks
Secondary	Decreased range of motion		12 weeks
Secondary	Radiographic finding of bone		12 weeks
Secondary	Bone metabolic marker		12 weeks