Ischemic StrokePhase 2NCT00639249
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
A Phase 2 study testing SA4503 Low and SA4503 High in people with Ischemic Stroke, run by M's Science Corporation at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SA4503 Low and SA4503 High
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with transient ischemic attack
- Patients with stroke in progression
- Unstable cardiac, hepatic, or renal disease, or other major medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Further study details as provided by M's Science Corporation:
- Conditions
- Ischemic Stroke
- Being tested
- placebo, SA4503 Low, SA4503 High
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Oral administration
SA4503 LowDrug
Oral administration
SA4503 HighDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Placebo Receives: Drug: placebo |
| A1 | Experimental | SA4503 Receives: Drug: SA4503 Low |
| A2 | Experimental | SA4503 Receives: Drug: SA4503 High |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 4 weeks
Secondary outcomes (1)
NIHSS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M's Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keith W Muir, MD, Principal investigator, Southern General Hospital, Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639249
- Sponsor's protocol ID
- ME1-2
- Other IDs
- EudraCT number: 2007-004840-60
- Status last verified
- Jul 2009
- First submitted
- 14 Mar 2008
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25270629
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00639249
- Acronym / sponsor ID
- ME1-2
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M's Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: placeboPlacebo |
| A1 | Experimental | Drug: SA4503 LowSA4503 |
| A2 | Experimental | Drug: SA4503 HighSA4503 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- Patients with transient ischemic attack
- Patients with stroke in progression
- Unstable cardiac, hepatic, or renal disease, or other major medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboOral administration | Drug | P |
| SA4503 LowOral administration | Drug | A1 |
| SA4503 HighOral administration | Drug | A2 |
Primary outcome
Safety and tolerability
Time frame: 4 weeks
1 secondary outcome
NIHSS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
- Derived from this study: PubMed 25270629Urfer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith W Muir, MD principal investigator
Southern General Hospital, Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SA4503 Low and SA4503 High in people with Ischemic Stroke, run by M's Science Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2009.