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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
placebo
SA4503 Low
SA4503 High
Sponsored by
M's Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

P

A1

A2

Arm Description

Placebo

SA4503

SA4503

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

NIHSS

Full Information

First Posted
March 14, 2008
Last Updated
July 28, 2009
Sponsor
M's Science Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00639249
Brief Title
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Phase IIa Study of Safety and Motor Function Restoration in Subjects Treated With SA4503 Following Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
M's Science Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A1
Arm Type
Experimental
Arm Description
SA4503
Arm Title
A2
Arm Type
Experimental
Arm Description
SA4503
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
SA4503 Low
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
SA4503 High
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
NIHSS
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith W Muir, MD
Organizational Affiliation
Southern General Hospital, Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern General Hospital
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25270629
Citation
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.
Results Reference
derived

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

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