Overview

This trial is active, not recruiting.

Condition severe upper limb hemiplegia
Treatments hc-58, placebo
Phase phase 2
Sponsor Asahi Kasei Pharma Corporation
Start date July 2012
End date May 2015
Trial size 270 participants
Trial identifier NCT01623622, HC-58 (SHS) II-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Low dose
hc-58
once or more / week
(Experimental)
High dose
hc-58
once or more / week
(Placebo Comparator)
placebo
once or more / week

Primary Outcomes

Measure
Onset of shoulder hand syndrome
time frame: 12 weeks
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
time frame: 12 weeks
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency
time frame: 12 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Asahi Kasei Pharma Corporation.