Overview

This trial has been completed.

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
Intervention model parallel assignment
Primary purpose prevention
Masking participant, investigator
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

All 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 2017.
Information provided to ClinicalTrials.gov by Asahi Kasei Pharma Corporation.