Safety and Preliminary Efficacy Study of SA4503 in Subjec... | NCT00639249

Studies
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke

NCT00639249

Sponsor

M's Science Corporation

Status

Completed

Last Update Posted

Jul 29, 2009Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Ischemic Stroke

Interventions

placebo
SA4503 Low
SA4503 High

Countries

United Kingdom

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

ID	Type	Description	Link
EudraCT number: 2007-004840-60

Status Module

Record Verification Date

Jul 2009

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

Feb 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Not provided

First Submitted Date

Mar 14, 2008

First Submission Date that Met QC Criteria

Mar 14, 2008

First Posted Date

Mar 20, 2008Estimated

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

Jul 28, 2009

Last Update Posted Date

Jul 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.

Detailed Description

Further study details as provided by M's Science Corporation:

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P	Placebo Comparator	Placebo	Drug: placebo
A1	Experimental	SA4503	Drug: SA4503 Low
A2	Experimental	SA4503	Drug: SA4503 High

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Oral administration	P
SA4503 Low

Measure	Description	Time Frame
Safety and tolerability		4 weeks

Measure	Description	Time Frame
NIHSS		4 weeks

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Males or females 18 years of age or older
Experienced a stroke from 48 to 72 hours before randomization
A total score of >/=4 on the NIHSS, or >/=2 on the upper or lower extremity motor scores of the NIHSS
Medically and neurologically stable within 24 hours prior to randomization

Key Exclusion Criteria:

Patients with transient ischemic attack
Patients with stroke in progression
Unstable cardiac, hepatic, or renal disease, or other major medical disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Keith W Muir, MD	Southern General Hospital, Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern General Hospital		Glasgow			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25270629	Derived	Urfer R, Moebius HJ, Skoloudik D, Santamarina E, Sato W, Mita S, Muir KW; Cutamesine Stroke Recovery Study Group. Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke. Stroke. 2014 Nov;45(11):3304-10. doi: 10.1161/STROKEAHA.114.005835. Epub 2014 Sep 30.

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases