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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01623622
Date of registration:	18/06/2012
Prospective Registration:	Yes
Primary sponsor:	Asahi Kasei Pharma Corporation
Public title:	Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke
Scientific title:	A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
Date of first enrolment:	July 2012
Target sample size:	270
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01623622
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
Phase:	Phase 2

Countries of recruitment
Japan

Contacts

Name:	Toshiya Umeda
Address:
Telephone:
Email:
Affiliation:	Asahi Kasei Pharma Corporation Clinical Development Center

Key inclusion & exclusion criteria

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

Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Severe Upper Limb Hemiplegia

Intervention(s)

Drug: Placebo

Drug: HC-58

Primary Outcome(s)

Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency [Time Frame: 12 weeks]

Change from Baseline in the modified Barthel index (MBI) and MBI efficiency [Time Frame: 12 weeks]

Onset of shoulder hand syndrome [Time Frame: 12 weeks]

Secondary Outcome(s)

Bone metabolic marker [Time Frame: 12 weeks]

Difference in skin temperature between hands [Time Frame: 12 weeks]

Discolouration of the skin of the hand [Time Frame: 12 weeks]

Swelling asymmetry between hands [Time Frame: 12 weeks]

Decreased range of motion [Time Frame: 12 weeks]

Pain score by numeric rating scale [Time Frame: 12 weeks]

Radiographic finding of bone [Time Frame: 12 weeks]

Secondary ID(s)

HC-58 (SHS) II-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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