Health Condition 1: G710- Muscular dystrophy
Conditions
Interventions
Intervention1: Deflazacort at 0.45mg/kg/day: The intervention arm will receive Deflazacort at 0.45mg/kg/day for 24 weeks duration.
Control Intervention1: Deflazacort at 0.9mg/kg/day: the comparative a
Sponsors
Dr Renu Suthar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Boys with a diagnosis of DMD: ( two should present) 1 With phenotypic characteristic symptoms or signs (waddling gait, Gowerâ??s sign, and calf hypertrophy) 2 Elevated CK, and positive genetic analysis of dystrophin gene or muscle biopsy that demonstrated a clear alteration in dystrophin amount or distribution in the muscle 3. He should be ambulatory at the time of enrolment 4. Baseline 6MWD should be more than 150 meters 5. Steroid naive patients or who have received 6. Willing for functional assessment and follow up in the clinic
Exclusion criteria
Exclusion criteria: 1.Prior long-term use of oral GCs for >6 months 2.Active peptic ulcer disease or history of any gastrointestinal or perforation 3.Boys with DMD and autism/ intellectual disability/ fractures 4.Not willing for giving written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the mean change in 6MWD (in meters) from base lineTimepoint: at 24 ± 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the mean change from base line to week 24 in time (in sec) for timed function tests and in muscle strength (lbs) for hand held myometery timed function tests 10 meter walk test 4 stair ascent time 4 stair descent time gowers time Hand held myometery at biceps and quadriceps femorisTimepoint: at 24 ± 4 weeks | — |
Countries
India
Contacts
Public ContactBandi V Chaitanya Reddy
Department of Pediatrics, Advanced Pediatric Centre
Outcome results
None listed