Arginine Therapy for Sickle Cell Disease (STArT Trial)

Palo Alto (17 mi)

Claudia R. Morris | Faculty | People ...

Overseen byClaudia Morris, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Emory University

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) is designed to further knowledge on efficacy and safety of the therapy.

Eligibility Criteria

The STArT trial is for children and young adults aged 3-21 with sickle cell disease experiencing pain episodes needing medical care. They must not have had certain treatments or hospitalizations recently, be stable without severe anemia, and able to understand English or Spanish.

Inclusion Criteria

I have been diagnosed with sickle cell disease.

I have had severe pain from sickle cell disease treated with strong painkillers.

Exclusion Criteria

I am 18 or older but cannot make medical decisions for myself.

I have had a recent stroke or there are concerns I might have one.

I have used ketamine in the ER for a pain crisis.

My hemoglobin is below 5 gm/dL or I urgently need a blood transfusion.

I have recent changes in my mental state or neurological condition.

I do not speak English or Spanish.

I respond well to IV pain medication.

I visited the ER 3+ times for sickle cell pain and received opioids in the last week.

I have low blood pressure needing treatment or have been unstable or in septic shock.

Treatment Details

This study tests IV arginine therapy versus saline (a placebo) in managing pain during vaso-occlusive episodes in sickle cell patients. It aims to determine the effectiveness and safety of arginine compared to a standard treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arginine HydrochlorideExperimental Treatment1 Intervention

Arginine is a nutritional supplement in parenteral form

Group II: PlaceboPlacebo Group1 Intervention

Normal saline

Arginine Hydrochloride is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as L-arginine for: