Health Condition 1: M628- Other specified disorders of muscle
Conditions
Interventions
Intervention1: Prednisone: Oral prednisone tablets at a dose of 0.75mg/kg/day (maximum 60mg/day) single daily dose in a 10 days-on and 10 days-off manner.
Control Intervention1: Prednisone: Oral pred
Sponsors
Maulana Azad Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. Boys with genetically confirmed mutation of the DMDgene. 2. Age : 4-12years. 3. Ambulatory at the start of study. 4. Glucocorticoid naïve
Exclusion criteria
Exclusion criteria: 1. Patients already on corticosteroid therapy. 2. Patients on any other investigational drug or those who have received stem cell therapy in the past. 3. Patients on anti epileptic drug therapy. 4. Those having active infection like Tuberculosis will be enrolled after 2 weeks of therapy or after the acute infection is treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in muscle strength as assessed by Motor Ability Score(MAS).Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in (a) MAS; (b) GSGC Score; c) Percentage MRC score; (d)6 â?? minute walk test(6MWD); and (e)serum CPK levels.Timepoint: 6 months;Improvement in muscle strength as assessed by (a) GSGC Score (Gait, Stairs, Gowerâ??s maneuver, arising from a Chair) b) Percentage Modified Research Council score (%MRC score); and c)6 â?? minute walk test(6MWD).Timepoint: 3 months;Improvement in serum creatine phosphokinase (CPK) levels.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactSeema Kapoor
Maulana Azad Medical College
Outcome results
None listed