Once Weekly Infant Corticosteroid Trial for DMD

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Anne M. Connolly
Study ID
NCT05412394
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
1 Month - 30 Months
Healthy Volunteers
Not accepted

Interventions

  • Prednisolone — DRUG
    Liquid, 5mg/kg per week, for one year

Study Details

The hypothesis tested here is that a lower dose of intermittent oral corticosteroids (5mg/kg/week) will be equally effective to the 10mg/kg/week dose.

Key Dates

Start date
Apr 30, 2021
Status verified
Feb 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    This is a one-arm study and the group of subjects are all experimental and will receive drug.

Primary Outcome Measure

The change from baseline to 24 months for the Gross Motor Scaled Score. [ Time Frame: Baseline visit to 24 month visit ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of CincinnatiCincinnatiOhio45220-
Nationwide Children's HospitalColumbusOhio43205
Kevin Warf, BS
[email protected]
(614) 355-2765
Anne Connolly, MD (PRINCIPAL_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75235
Shahera Ranjha, MS
[email protected]
214-456-5959

Find similar trials in Chicago, IL

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Cincinnati· Cincinnati, OHNationwide Children's Hospital· Columbus, OHUniversity of Texas Southwestern· Dallas, TX

Related Studies