NL-OMON50318
Completed
Phase 2
A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VBP15-004 - VISION DMD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ReveraGen BioPharma, Inc.
- Enrollment
- 7
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject's parent(s) or legal guardian(s) has (have) provided written
- •informed consent and Health Insurance Portability and Accountability Act
- •(HIPAA) authorization, where applicable, prior to any study\-related procedures;
- •participants will be asked to give written or verbal assent according to local
- •requirements
- •2\. Subject has a centrally confirmed (by TRiNDS central genetic counselor\[s])
- •diagnosis of DMD as defined as:
- •\* Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
- •deficiency, and clinical picture consistent with typical DMD, OR
- •\* Identifiable mutation within the DMD gene (deletion/duplication of one or
Exclusion Criteria
- •1\. Subject has current or history of major renal or hepatic impairment,
- •diabetes mellitus or immunosuppression;
- •2\. Subject has current or history of chronic systemic fungal or viral
- •infections;
- •3\. Subject has had an acute illness within 4 weeks prior to the first dose of
- •study medication;
- •4\. Subject has used mineralocorticoid receptor agents, such as spironolactone,
- •eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium),
- •mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of
- •study medication;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2NL-OMON52170Astra Zeneca9
Completed
Phase 2
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitisinflamatory bowel diseaseUlcerative colitis10017969NL-OMON46940Eli Lilly and Company7
Recruiting
Phase 2
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetesType 1 diabetesDiabetes10018424NL-OMON49006Diamyd Medical AB2
Completed
Phase 2
A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosism (ALS)Motor Neuron Disease10029317NL-OMON45879Cytokinetics, Inc.11
Completed
Phase 2
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients With Heterozygous Familial HypercholesterolemiaNL-OMON45499Madrigal Pharmaceuticals, Inc.24