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New treatment option for Rhabdomyolysis
Official title Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
ClinicalTrials.gov ID: NCT06429982
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rhabdomyolysis.
Also referred to as DexPak.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 25
You may be able to join if
- Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded
- Ability of parents/patients to understand and the willingness to sign a written informed consent document.
- Patients ages 12 and older will sign written assent
You likely can't join if
- Already taking systemic steroids.
- Inability to comply with study instructions.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women. o A urine pregnancy test will be performed for women of child-bearing potential.
- Below gestational age of 40 weeks
- Allergy to fluconazole, clotrimazole or nystatin.
See the full eligibility criteria
- Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded
- Ability of parents/patients to understand and the willingness to sign a written informed consent document.
- Patients ages 12 and older will sign written assent
- Already taking systemic steroids.
- Inability to comply with study instructions.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women. o A urine pregnancy test will be performed for women of child-bearing potential.
- Below gestational age of 40 weeks
- Allergy to fluconazole, clotrimazole or nystatin.
- Cannot tolerate PO medications
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.