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Amino Acid

Arginine Therapy for Sickle Cell Disease (STArT Trial)

Phase 3
Waitlist Available
Led By Claudia Morris, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established diagnosis of sickle cell disease (any genotype); AND
Pain requiring medical care in an acute care setting (ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids.
Must not have
Adults 18 years or older who lack medical decision-making capacity to consent
Acute stroke or clinical concern for stroke; OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether IV arginine therapy is effective and safe for children with VOE in SCD.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, arginine therapy could potentially cause allergic reactions, low blood pressure, electrolyte imbalances, or exacerbate existing conditions related to sickle cell disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with sickle cell disease.
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I have had severe pain from sickle cell disease treated with strong painkillers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am 18 or older but cannot make medical decisions for myself.
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I have had a recent stroke or there are concerns I might have one.
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I have used ketamine in the ER for a pain crisis.
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My hemoglobin is below 5 gm/dL or I urgently need a blood transfusion.
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I have recent changes in my mental state or neurological condition.
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I do not speak English or Spanish.
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I respond well to IV pain medication.
Select...
I visited the ER 3+ times for sickle cell pain and received opioids in the last week.
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I have low blood pressure needing treatment or have been unstable or in septic shock.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in time-to-crisis resolution
Secondary study objectives
Change in PROMIS Fatigue score
Pain
Change in PROMIS Pain Interference score
+2 more
Other study objectives
Change in Arginine bioavailability
Change in Medication Quantification Score (MQS)
Change in Pediatric PROMIS score
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,934 Previous Clinical Trials
47,791,916 Total Patients Enrolled
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,458 Total Patients Enrolled
Claudia R. MorrisLead Sponsor

Media Library

Arginine Hydrochloride (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT04839354 — Phase 3
Sickle Cell Disease Research Study Groups: Arginine Hydrochloride, Placebo
Sickle Cell Disease Clinical Trial 2023: Arginine Hydrochloride Highlights & Side Effects. Trial Name: NCT04839354 — Phase 3
Arginine Hydrochloride (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839354 — Phase 3
~114 spots leftby Jul 2026
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