← Back to Search

Scp776 for Stroke (ARPEGGIO Trial)

Phase 2

Recruiting

Research Sponsored by Silver Creek Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight of less than 150 kg

Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization

Must not have

Subjects with end-stage kidney disease

Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g. aortic dissection, carotid stent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 7 or at hospital discharge (whichever occurs first).

Summary

This trial studied the safety and effectiveness of a drug to help protect the brain after stroke, using a rigorous research design.

Who is the study for?

This trial is for adults over 18 with a body weight under 150 kg who are experiencing a severe, disabling stroke and are set to undergo endovascular thrombectomy. They must have had symptoms start within the last 16 hours and not be on certain blood thinners or have conditions that could interfere with the study.

What is being tested?

The study tests Scp776 at two different doses (1.9 mg/kg and 3.8 mg/kg) against a placebo in patients having an acute ischemic stroke to see if it's safe and can protect brain cells. It's randomized, meaning participants are put into groups by chance, double-blind so neither doctors nor patients know who gets what treatment.

What are the potential side effects?

While specific side effects of Scp776 aren't listed here, common risks may include allergic reactions to the drug or infusion-related issues like discomfort or pain at injection site; other potential side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My body weight is under 150 kg.

Select...

I have had a severe stroke with significant symptoms.

Select...

I have a confirmed blockage in my brain's arteries.

Select...

I am planned to undergo a procedure using a device inside my blood vessels.

Select...

I am scheduled for an immediate blood vessel procedure for my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have end-stage kidney disease.

Select...

I do not have arterial conditions like aortic dissection or carotid stent that would interfere with blood flow restoration.

Select...

I am scheduled for a treatment to dissolve blood clots in my arteries.

Select...

I am on long-term blood thinners like warfarin or apixaban.

Select...

I am severely allergic to contrast dye used in certain scans.

Select...

My cancer has spread and is expected to not improve much.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 7 or at hospital discharge (whichever occurs first).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 7 or at hospital discharge (whichever occurs first).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 7 or at hospital discharge (whichever occurs first). for reporting.