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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 90
Awards & highlights
ARPEGGIO Trial 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.Check my eligibility
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.See study design
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.
ARPEGGIO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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I am scheduled for an immediate blood vessel procedure for my stroke.
ARPEGGIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in NIHSS from baseline to Day 7 or at hospital discharge (whichever occurs first).
Secondary outcome measures
Change in Barthel Index score at Day 90 from baseline
Change in Modified Rankin Scale score at Day 30 from baseline
Change in Modified Rankin Scale score at Day 90 from baseline
+3 moreARPEGGIO Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: scp776 (3.8 mg/kg)Experimental Treatment1 Intervention
Cohort 2 dose regimen:
Intravenous (IV) injection(s) over 2 minutes
- 3.8 mg/kg
Group II: scp776 (1.9 mg/kg)Experimental Treatment1 Intervention
Cohort 1 dose regimen:
Intravenous (IV) slow injection(s) over 2 minutes
- 1.9 mg/kg
Group III: PlaceboPlacebo Group1 Intervention
Volume Matched Placebo (normal saline)
Find a Location
Who is running the clinical trial?
Silver Creek PharmaceuticalsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term blood thinners like warfarin or apixaban.The time between when you last felt well and when you join the study is less than 16 hours.I am 18 years old or older.I have end-stage kidney disease.I do not have arterial conditions like aortic dissection or carotid stent that would interfere with blood flow restoration.My body weight is under 150 kg.I am scheduled for a treatment to dissolve blood clots in my arteries.I have had a severe stroke with significant symptoms.I am scheduled for an immediate blood vessel procedure for my stroke.I have a confirmed blockage in my brain's arteries.I am planned to undergo a procedure using a device inside my blood vessels.The history or previous tests show that the blockage in the brain has been there for a long time, or there is a suspected tear in the blood vessels of the brain that makes it unlikely for the treatment to work.I am currently receiving or have recently had clot-dissolving medication for a stroke.I am severely allergic to contrast dye used in certain scans.You have signs of recent bleeding inside your brain, as seen on a special type of picture taken by a doctor.You have poor or no alternative blood circulation pathways.My cancer has spread and is expected to not improve much.Your ASPECT score is between 0 and 4.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: scp776 (1.9 mg/kg)
- Group 3: scp776 (3.8 mg/kg)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the potential risks of administering SCP 776 (1.9 mg/kg) to human subjects?
"Scp776 (1.9 mg/kg) is judged to be reasonably safe as it has achieved Phase 2 status in clinical trials, which indicates that there are some safety metrics present but no efficacy data yet available."
Answered by AI
What is the scope of participation in this experiment?
"Affirmative. Information found on clinicaltrials.gov conveys that this experiment, initially posted on October 19th 2022, is currently in search of patients to join the medical trial. A total of 80 participants are required at 1 location."
Answered by AI
Are there still available opportunities to enroll in this clinical experiment?
"Indeed, according to clinicaltrials.gov, this medical experiment is accepting participants and has been since October 19th 2022. The most recent edit was posted on January 17 2023 with the aim of recruiting 80 patients from a single site."
Answered by AI
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