NCT00639249

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

1.3 years

First QC Date

March 14, 2008

Last Update Submit

July 28, 2009

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    4 weeks

Secondary Outcomes (1)

  • NIHSS

    4 weeks

Study Arms (3)

P

PLACEBO COMPARATOR

Placebo

Drug: placebo

A1

EXPERIMENTAL

SA4503

Drug: SA4503 Low

A2

EXPERIMENTAL

SA4503

Drug: SA4503 High

Interventions

placeboDRUG

Oral administration

P
SA4503 LowDRUG

Oral administration

A1
SA4503 HighDRUG

Oral administration

A2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern General Hospital

Glasgow, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25270629DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Keith W Muir, MD

    Southern General Hospital, Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

GB(1)