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Could an amino acid shorten sickle cell pain crises?

NCT ID NCT04839354

Symptom relief Sponsor: Claudia R. Morris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether intravenous arginine, an amino acid, can shorten painful episodes in children with sickle cell disease. Participants aged 3 to 21 receive either arginine or a placebo alongside standard pain treatment. The study measures how quickly the crisis resolves and how much opioid pain medication is needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
L-arginine hydrochloride
What this could lead to
If it works, this could provide a new, safer way to shorten painful sickle cell crises and reduce reliance on opioids for children.
What could go wrong
This is an early-phase trial, and arginine may not prove more effective than placebo. Potential side effects include allergic reactions or metabolic imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

271 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 3-21 years of age, inclusive 2. Established diagnosis of sickle cell disease (any genotype) 3. Pain requiring medical care in an acute care setting (emergency department, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids Exclusion Criteria: 1. Responds to 2 doses of IV opioids sufficiently for outpatient management 2. Greater than 12 hours from first dose of intravenous opioids to treat current pain in acute care setting 3. Hemoglobin less than 5 gm/dL or emergent need for red blood cell transfusion for hemodynamically unstable patient 4. Ketamine use in the emergency department for treatment of VOE 5. Glutamine within 30 days 6. New SCD drug use \< 3 months (e.g. Hydroxyurea, voxelotor, crizanlizumab, etc) 7. Acute mental status or neurological changes 8. Acute stroke or clinical concern for stroke 9. Three or more ED visits for sickle cell related pain receiving parenteral opioids in previous 7 days (not including current emergency department visit) 10. Hospital discharge within previous 7 days 11. Hypotension requiring clinical intervention; hemodynamic instability; septic shock 12. Previous randomization in this arginine phase 3 randomized controlled trial 13. Use of inhaled nitric oxide, sildenafil or arginine within the last month 14. Non-English speaking or requires a translator for clinical care 15. Pregnancy 16. Allergy to arginine 17. PI/clinical team concerns for compliance/issues that may adversely impact study participation/outcome 18. Adults 18 years or older who lack medical decision-making capacity to consent

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Conditions

The condition(s) this trial relates to.

agnosia sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia, 30322, United States

  • Children's Healthcare of Atlanta at Hughes Spalding

    Atlanta, Georgia, 03322, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical College of Wisconsin/Wisconsin Children's Hospital

    Wauwatosa, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Texas Children's Hospital/Baylor College of Medicine

    Houston, Texas, 77030, United States

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94158, United States

  • Washington University/St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.