A Phase 1 interventional study of Dexamethasone and Placebo in Rhabdomyolysis, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Children's National Research Institute · Phase 1, Interventional, and Treatment
There is a significant unmet need for optimized treatment in rhabdomyolysis. There are few prospective interventional studies on treatment for rhabdomyolysis, a condition which affects diverse and underrepresented populations at a higher rate. While steroids are often used off-label, a systematic study has not yet been initiated, and steroids have not been yet considered in as a consideration to standard care guidelines.
The hypothesis is that patients who receive dexamethasone in addition to standard care versus placebo and standard care will have improvement in pain, length of hospital stay, and decrease in kidney complications.
Study Objective:
This is a single center, 2-year, blinded prospective randomized study for those diagnosed with rhabdomyolysis age six months-25 years using dexamethasone versus placebo treatment in addition to standard care in up to 50 patients.
Study Design:
Patients will be enrolled with a 2:1 ratio of treatment of dexamethasone for 5 days versus placebo treatment for 5 days in addition to receiving standard care. The treatment period for each subject will be five days treatment with oral treatment once per day with study drug (dexamethasone versus placebo). All patients will also receive standard care. Patients and their parent/ caregiver will have the option to complete surveys before and after treatment in order to assess pain level and treatment improvement. Chart review will be performed on all patients throughout and after the five-day study treatment period. There will be no additional interventions.
40 studies on the registry are indexed under Rhabdomyolysis; 5 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 14 interventional studies indexed under Rhabdomyolysis.
Browse Rhabdomyolysis studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant women.
o A urine pregnancy test will be performed for women of .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexamethasone five days with 0.6 mg/ kg dose per day max 16 mg dose. Standard care will also be provided.
Drug: Dexamethasone
Placebo for five days with one dose per day placebo oral dosing. Standard care will also be provided.
Drug: Placebo
Steroid five day treatment
Also known as: DexPak
Placebo control group
Also known as: Sugar Pill
Length of Stay
Number of days Length of Stay in Each Group
Time frame: Primarily 5 days - 1 year
Muscle breakdown
Creatinine Kinase trend comparison between groups
Time frame: Primarily 5 days - 1 year
Renal complications
Bun/ Creatinine
Time frame: Primarily 5 days - 1 year
Quantitative Pain Outcomes
EHR pain scores
Time frame: 14 days
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.
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Studies of the drug tested here: Dexamethasone
Children's National Research Institute →