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14
datasets available to search
ShareScore release 0.9.0
Dataset results
14 results for “vamorolone”
An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
ClinicalTrials.gov study NCT02760277. IPD Sharing: Not stated. Countries: 6. Publications: 3.
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
ClinicalTrials.gov study NCT06649409. IPD Sharing: NO. Countries: 1. Publications: 1.
Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
ClinicalTrials.gov study NCT03038399. IPD Sharing: Not stated. Countries: 6. Publications: 2.
A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
ClinicalTrials.gov study NCT03439670. IPD Sharing: Not stated. Countries: 11. Publications: 44.
A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
ClinicalTrials.gov study NCT05185622. IPD Sharing: NO. Countries: 1. Publications: 22.
A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
ClinicalTrials.gov study NCT02760264. IPD Sharing: UNDECIDED. Countries: 6. Publications: 3.
Supplemental data from: Adrenal suppression from vamorolone and prednisone in Duchenne muscular dystrophy: results from the phase 2b clinical trial
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Data from: Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function
Objective: We carried out first-in-patient studies of vamorolone, a first-in-class dissociative steroidal anti-inflammatory drug, in Duchenne muscular dystrophy. Methods: An open-label, multiple-ascending dose study of vamorolone was conducted in 48 boys with Duchenne muscular dystrophy (4 to <7 years, steroid-naïve). Dose levels were 0.25, 0.75, 2.0 and 6.0 mg/kg/day using an oral suspension formulation (12 boys/dose level; 1/3rd to 10x glucocorticoid dose in DMD). Results: Over a 24-week treatment period, oral administration of vamorolone at all doses tested was safe and well-tolerated. The 2.0 mg/kg/day dose group met the primary efficacy outcome of improved muscle function (time to stand; 24 weeks vamorolone treatment versus natural history controls), without evidence of most adverse effects of glucocorticoids. Significant dose-responsive improvements in 10 meter run/walk, and six-minute walk test were observed for 2.0 and 6.0 mg/kg/day dose groups. The morbidity of most concern to many chronic glucocorticoid users, bone loss, was not seen with vamorolone at any dose, as evidenced by serum osteocalcin. Biomarker outcomes for adrenal suppression and insulin resistance were also less impacted in vamorolone-treated DMD patients, relative to published studies of glucocorticoid therapy. Conclusions: Vamorolone demonstrated both efficacy and a reduction in adverse effects in DMD patients compared to traditional glucocorticoids in a 24-week, open-label study. Vamorolone has potential to replace chronic glucocorticoids in many disorders where side effects detract from patient quality of life. Classification of Evidence: This study provides Class II evidence that certain dosages of vamorolone are well tolerated and effective in improving muscle function in DMD.
A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy
ClinicalTrials.gov study NCT06713135. IPD Sharing: Not stated. Countries: 9. Publications: 5.
A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
ClinicalTrials.gov study NCT05166109. IPD Sharing: NO. Countries: 2. Publications: 23.
Data from: Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function
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Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
ClinicalTrials.gov study NCT06689527. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.
ClinicalTrials.gov study NCT06564974. IPD Sharing: NO. Countries: 2. Publications: 0.
Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis
ClinicalTrials.gov study NCT04348890. IPD Sharing: NO. Countries: 0. Publications: 0.
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