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

Active, not recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: once or more / week
    ARM 1: Kind: Experimental
    Label: Placebo
  • HC-58 Drug
    Intervention Desc: once or more / week
    ARM 1: Kind: Experimental
    Label: HC-58 low dose
    Description: Low dose
    ARM 2: Kind: Experimental
    Label: HC-58 high dose
    Description: High dose

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Onset of shoulder hand syndrome 12 weeks No
Primary Change from Baseline in the modified Barthel index (MBI) and MBI efficiency 12 weeks No
Primary Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency 12 weeks No
Secondary Pain score by numeric rating scale 12 weeks No
Secondary Swelling asymmetry between hands 12 weeks No
Secondary Discolouration of the skin of the hand 12 weeks No
Secondary Difference in skin temperature between hands 12 weeks No
Secondary Decreased range of motion 12 weeks No
Secondary Radiographic finding of bone 12 weeks No
Secondary Bone metabolic marker 12 weeks No

Sponsors