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Corticosteroid

Prednisone for Becker Muscular Dystrophy (WSiMD Trial)

Phase 2
Waitlist Available
Led By Senda Ajroud-Driss, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Becker muscular dystrophy or LGMD2A (CAPN3), LGMD 2B (DYSF), LGMD 2C (SGCG), LGMD2E (SGCB), LGMD2F (SGCD), LGMD 2I (FKRP), LGMD (ANO5). Genetic mutation or muscle biopsy staining required to confirm genetic subtype
Ages 18-65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6
Awards & highlights

WSiMD Trial Summary

This trial will evaluate the safety and efficacy of oral weekly glucocorticoid steroids in patients with Becker Muscular Dystrophy and Limb Girdle Muscular Dystrophy. The primary objective is safety and the secondary objective is efficacy.

Eligible Conditions
  • Becker Muscular Dystrophy
  • Limb-Girdle Muscular Dystrophy

WSiMD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

WSiMD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Creatine Kinase
Fasting Glucose
Fasting Lipid Profile
+2 more
Secondary outcome measures
10 Meter Run Timed
6 Minute Walk Test
Bone Density
+7 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

WSiMD Trial Design

1Treatment groups
Experimental Treatment
Group I: Weekly SteroidExperimental Treatment1 Intervention
Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,578 Previous Clinical Trials
917,375 Total Patients Enrolled
Senda Ajroud-Driss, MDPrincipal InvestigatorAssociate Professor of Neurology (Neuromuscular Disease)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~4 spots leftby Mar 2025