Study of HC-58 in Upper Limb Hemiplegic Patients After St... | NCT01623622

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

NCT01623622

Sponsor

Asahi Kasei Therapeutics Corporation

Status

Completed

Last Update Posted

Feb 15, 2017Actual

Enrollment

270Estimated

Phase

Phase 2

Conditions

Severe Upper Limb Hemiplegia

Interventions

HC-58
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jun 18, 2012

First Submission Date that Met QC Criteria

Jun 18, 2012

First Posted Date

Jun 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HC-58 low dose	Experimental	Low dose	Drug: HC-58
HC-58 high dose	Experimental	High dose	Drug: HC-58
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HC-58	Drug	once or more / week	HC-58 high dose HC-58 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset of shoulder hand syndrome	The incidence rate of shoulder hand syndrome	12 weeks
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency	MBI efficiency means MBI gain divided by period of administration	12 weeks
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency	FMA efficiency means FMA gain divided by period of administration	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain score by numeric rating scale		12 weeks
Swelling asymmetry between hands		12 weeks
Discolouration of the skin of the hand

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Toshiya Umeda	Asahi Kasei Pharma Corporation Clinical Development Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Fukui-shi	Fukui		Japan