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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 belowSelect...
I have been diagnosed with sickle cell disease.
Select...
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:Select...
I am 18 or older but cannot make medical decisions for myself.
Select...
I have had a recent stroke or there are concerns I might have one.
Select...
I have used ketamine in the ER for a pain crisis.
Select...
My hemoglobin is below 5 gm/dL or I urgently need a blood transfusion.
Select...
I have recent changes in my mental state or neurological condition.
Select...
I do not speak English or Spanish.
Select...
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.
Select...
I have low blood pressure needing treatment or have been unstable or in septic shock.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
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 moreOther study objectives
Change in Arginine bioavailability
Change in Medication Quantification Score (MQS)
Change in Pediatric PROMIS score
+3 moreAwards & 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
3,922 Previous Clinical Trials
47,760,378 Total Patients Enrolled
Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,331 Total Patients Enrolled
Claudia R. MorrisLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older but cannot make medical decisions for myself.I have not taken glutamine in the last 30 days.You are allergic to arginine.It's been over 12 hours since my last IV pain medication in the hospital.I have had a recent stroke or there are concerns I might have one.I have been diagnosed with sickle cell disease.I started a new sickle cell disease medication less than 3 months ago.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.I have used inhaled nitric oxide, sildenafil, or arginine in the last month.I have had severe pain from sickle cell disease treated with strong painkillers.I am between 3 and 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Arginine Hydrochloride
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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