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

Asahi Kasei Medical

Status and phase: Completed; Phase 2

Conditions: Severe Upper Limb Hemiplegia

Treatments: Drug: Placebo; Drug: HC-58

Study type: Interventional

Funder types: Industry

Identifiers

NCT01623622

HC-58 (SHS) II-1

Details and patient eligibility

About

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

Enrollment: 270 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 3 patient groups, including a placebo group

HC-58 low dose

Experimental group

Description:

Low dose

Treatment:

Drug: HC-58

HC-58 high dose

Experimental group

Description:

High dose

Treatment:

Drug: HC-58

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo