Daily Vs. Alternate day steroids for Improving Motor Function in Duchenne Muscular Dystrophy
Not Applicable
- Conditions
- Health Condition 1: M628- Other specified disorders of muscle
- Registration Number
- CTRI/2019/01/016965
- Lead Sponsor
- Maulana Azad Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in muscle strength as assessed by Motor Ability Score(MAS).Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>(a) GSGC Score (Gait, Stairs, Gowerâ??s maneuver, arising from a Chair) <br/ ><br>b) Percentage Modified Research Council score (%MRC score); and <br/ ><br>c)6 â?? minute walk test(6MWD).Timepoint: 3 months;Improvement in serum creatine phosphokinase (CPK) levels.Timepoint: 3 months