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Spironolactone Versus Prednisolone in DMD

NCT03777319 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-10-23

Study results available
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Summary

This is a randomized, open-label, pilot clinical trial of spironolactone suspension versus oral prednisolone for use in Duchenne muscular dystrophy. The goals are to determine the safety of 6 months of treatment with spironolactone treatment int he steroid-naive DMD population as well as to determine if either spironolactone or a standard clinical dose of corticosteroids results in equivalent improvement in time to complete the 100 meter timed test (100M).

Conditions

  • Muscular Dystrophy, Duchenne

Interventions

DRUG

Spironolactone

Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.

DRUG

Prednisolone

Prednisolone will be prescribed for 6 months as the clinical standard of care.

Sponsors & Collaborators

Principal Investigators

  • Kevin Flanigan, MD · Nationwide Children's Hospital

  • Megan Waldrop, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2021-09-27
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777319 on ClinicalTrials.gov