NCT01623622 is a Phase 2 clinical trial of HC-58 in Severe Upper Limb Hemiplegia, sponsored by Asahi Kasei Therapeutics Corporation.

Who is sponsoring NCT01623622?

NCT01623622 is sponsored by Asahi Kasei Therapeutics Corporation.

What drugs are being tested in NCT01623622?

Interventions in NCT01623622: HC-58, Placebo.

What condition does NCT01623622 study?

NCT01623622 studies Severe Upper Limb Hemiplegia.

Is NCT01623622 still recruiting?

NCT01623622 is currently completed. Last updated 13 February 2017.

Last reviewed 2017-02-13 · How we verify

NCT01623622

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 13 February 2017

What this trial tests

Phase 2 trial testing HC-58 in Severe Upper Limb Hemiplegia in 270 participants. Completed in 1 May 2015.

Timeline

1 July 2012

Primary endpoint
1 May 2015

1 May 2015

Quick facts

Lead sponsor	Asahi Kasei Therapeutics Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	270
Start date	1 July 2012
Primary completion	1 May 2015
Estimated completion	1 May 2015
Sites	3 locations across Japan

Drugs / interventions tested

HC-58 — full drug profile →
Placebo

Conditions studied

Severe Upper Limb Hemiplegia — all drugs for Severe Upper Limb Hemiplegia →

Sponsor

Asahi Kasei Therapeutics Corporation

Who can join

20 and older, any sex, with Severe Upper Limb Hemiplegia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Onset of shoulder hand syndrome
Time frame: 12 weeks
The incidence rate of shoulder hand syndrome
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
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

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Asahi Kasei Therapeutics Corporation trials

Trials by the same sponsor.

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NCT04483297 — First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) · Phase 1 · terminated
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01623622 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Asahi Kasei Therapeutics Corporation
Last refreshed: 13 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01623622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing