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Completed

NCT Number: NCT01623622

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

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

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Key information

Conditions

Severe Upper Limb Hemiplegia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fukui-shi, Fukui, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HC-58

Drug

once or more / week

Placebo

Drug

once or more / week

Primary outcomes

  1. Onset of shoulder hand syndrome

    Time frame: 12 weeks

    The incidence rate of shoulder hand syndrome

  2. Change from Baseline in the modified Barthel index (MBI) and MBI efficiency

    Time frame: 12 weeks

    MBI efficiency means MBI gain divided by period of administration

  3. Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency

    Time frame: 12 weeks

    FMA efficiency means FMA gain divided by period of administration

Secondary outcomes

  1. Pain score by numeric rating scale

    Time frame: 12 weeks

  2. Swelling asymmetry between hands

    Time frame: 12 weeks

  3. Discolouration of the skin of the hand

    Time frame: 12 weeks

  4. Difference in skin temperature between hands

    Time frame: 12 weeks

  5. Decreased range of motion

    Time frame: 12 weeks

  6. Radiographic finding of bone

    Time frame: 12 weeks

  7. Bone metabolic marker

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Asahi Kasei Therapeutics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2012
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.