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Trial record 3 of 69 for:    /kg | "muscular dystrophy, duchenne and becker types"

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

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ClinicalTrials.gov Identifier: NCT03439670
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
European Union
Cooperative International Neuromuscular Research Group
Newcastle University
University of Pittsburgh
Information provided by (Responsible Party):
ReveraGen BioPharma, Inc.

Brief Summary:
Brief Summary: This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Drug: Vamorolone Drug: Prednisone Other: Placebo Phase 2

Detailed Description:

This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.

The study is comprised of a 5-week Pretreatment Screening Period, a 1-day Pretreatment Baseline Period, a 24 week Treatment Period #1 (Weeks 1-24), a 4 week Transition Period (Weeks 25-28), a 20-week Treatment Period #2 (Weeks 28+ 1 day to 48), and a 4-week Dose-tapering Period (Weeks 49-52).

Subjects will be randomized to one of six treatment groups in a 2:2:1:1:1:1 ratio, where the two prednisone groups in Treatment Period #1 (Groups 3 and 4) will be combined and the two placebo groups in Treatment Period #1 (Groups 5 and 6) will be combined, effectively resulting in a 1:1:1:1 randomization (vamorolone 2.0 mg/kg/day : vamorolone 6.0 mg/kg/day : prednisone 0.75 mg/kg/day : placebo) for Treatment Period #1.

Subjects will be stratified based on age at study entry (<6 vs. ≥ 6 years). During the 4-week Transition Period between Treatment Period #1 and Treatment Period #2, all subjects will continue on the same oral suspension (vamorolone 2.0 mg/kg or 6.0 mg/kg, or matching placebo) they received during Treatment Period #1 and all subjects will have their tablet dose tapered to zero. Thus, subjects randomized to receive vamorolone during Treatment Period #1 (Groups 1 and 2) will continue to receive vamorolone at the same dose, while subjects randomized to receive prednisone will have their dose tapered to zero, and subjects randomized to placebo will continue to receive placebo.

A total of approximately 120 subjects will be randomized (2:2:1:1:1:1) to treatment.

The prednisone group will be used as an active control comparison for safety and efficacy endpoints as requested by the European Medicines Agency (EMA). The placebo group will be used as comparator for efficacy endpoints (superiority model) as requested by the EMA and Food and Drug Administration (FDA) protocol advisory board.

At the end of the Treatment Period #2, subjects will be given the option of enrolling into a long-term extension study (VBP15-005) or to transition to standard of care treatment for DMD (may include glucocorticoids). Subjects completing VBP15-004 and enrolling directly into VBP15 005 will not need to taper their vamorolone dose prior to enrollment into VBP15 005. All other subjects will begin a 4 week double blind Dose tapering Period during which the dose of study medication will be progressively reduced and discontinued.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020


Arm Intervention/treatment
Experimental: Treatment Group 1
Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for the duration of the study.
Drug: Vamorolone
Oral administration of 2.0 mg/kg/day for the duration of the study.
Other Name: VBP15

Experimental: Treatment Group 2
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone at 6.0 mg/kg/day for the duration of the study.
Drug: Vamorolone
Oral administration of 6.0 mg/kg/day for the duration of the study.
Other Name: VBP15

Active Comparator: Treatment Group 3
Patients enrolled in Treatment Group 3 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by 20 weeks of treatment with 2.0 mg/kg/day vamorolone.
Drug: Prednisone
Oral administration of 0.75 mg/kg/day for 24 weeks.

Drug: Vamorolone
Oral administration of 2.0 mg/kg/day for 20 weeks.
Other Name: VBP15

Active Comparator: Treatment Group 4
Patients enrolled in Treatment Group 4 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by 20 weeks treatment with 6.0 mg/kg/day vamorolone.
Drug: Prednisone
Oral administration of 0.75 mg/kg/day for 24 weeks.

Drug: Vamorolone
Oral administration of 6.0 mg/kg/day for 20 weeks.
Other Name: VBP15

Placebo Comparator: Treatment Group 5
Patients enrolled in Treatment Group 5 (placebo comparator group) will receive placebo daily for 24 weeks followed by 20 weeks treatment with 2.0 mg/kg/day vamorolone.
Other: Placebo
Oral administration of placebo daily for 24 weeks.

Drug: Vamorolone
Oral administration of 2.0 mg/kg/day for 20 weeks.
Other Name: VBP15

Placebo Comparator: Treatment Group 6
Patients enrolled in Treatment Group 6 (placebo comparator group) will receive placebo daily for 24 weeks followed by 20 weeks treatment with 6.0 mg/kg/day vamorolone.
Other: Placebo
Oral administration of placebo daily for 24 weeks.

Drug: Vamorolone
Oral administration of 6.0 mg/kg/day for 20 weeks.
Other Name: VBP15




Primary Outcome Measures :
  1. Muscle function measured by Time to Stand Test (TTSTAND) [ Time Frame: 24 weeks ]
    (vamorolone at 2.0mg/kg/day and 6.0mg/kg/day vs. placebo)

  2. Body Size as measured by body mass index (BMI) z-score [ Time Frame: 24 weeks ]
    (vamorolone at 2.0mg/kg/day and 6.0mg/kg/day vs. prednisone at 0.75 mg/kg/day)


Secondary Outcome Measures :
  1. Safety measure by Treatment emergent adverse events (TRAEs) and serious adverse events (SAEs) by organ system class (SOC). [ Time Frame: 48 weeks ]
    Overall by treatment, by treatment and relationship, and by treatment and intensity.

  2. Safety measure assessed by sitting blood pressure. [ Time Frame: Day 1, Week 2, Week 6, Week 12,Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  3. Safety measure assessed by heart rate. [ Time Frame: Day 1, Week 2, Week 6, Week 12,Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  4. Safety measured assessed by respiratory rate. [ Time Frame: Day 1, Week 2, Week 6, Week 12,Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  5. Safety measure assesed by body temperature. [ Time Frame: Day 1, Week 2, Week 6, Week 12,Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  6. Safety measure assessed by body weight. [ Time Frame: Week 2, Week 6, Week 12, Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  7. Safety measure assessed by height [ Time Frame: Week 12, Week 24, Week 34, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  8. Cushingoid features measured by the presence of buffalo hump obesity, striations, adiposity, hypertension, diabetes, or osteoporosis [ Time Frame: Week 6, Week 12, Week 18, Week 24, Week 28, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  9. Safety measure assessed by blood laboratory measures. [ Time Frame: Day 1, Week 2, Week 6, Week 12, Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  10. Safety measure assessed by urine laboratory measures. [ Time Frame: Day 1, Week 2, Week 6, Week 12, Week 18, Week 24, Week 28, Week 30, Week 34, Week 40, Week 48 ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  11. Cardiac function measured by 12 lead electrocardiogram (ECG) [ Time Frame: Week 12, Week 24, Week 40, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  12. Cardiac function measured by 2-D echocardiogram. [ Time Frame: Week 24, Week 48. ]
    Change from baseline to each of the scheduled on-treatment and post-treatment assessment time points.

  13. Safety measure based on dual-energy x-ray absorptiometry (DXA) scan. [ Time Frame: Week 24, Week 48. ]
    Change from baseline to Week 24 and Week 48 in BMD Z-score.

  14. Spine Fracture measured by spine X-ray [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 assessment.

  15. Cataracts measured by the presence of partial or complete opacity of the crystalline lens of one or both eyes. [ Time Frame: Week 24, Week 48 ]
    Week 24 and Week 48 assessments compared to baseline

  16. Glaucoma measured by measured by ocular pressure. [ Time Frame: Week 24, Week 48 ]
    Week 24 and Week 48 assessments compared to baseline

  17. Safety measured assessed by Synacthen (ACTH) test [ Time Frame: 24, 48 weeks ]
  18. Efficacy measured by Time to Stand Test (TTSTAND) [ Time Frame: 48 weeks ]
    (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  19. Efficacy measured by Time to Climb (TTCLIMB). [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  20. Efficacy as measured by Time to Run/Walk Test (TTRW). [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  21. Efficacy as measured by total distance traveled in meters, in completing the Six-minute Walk Test (6MWT) [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  22. Efficacy as measured by the North Star Ambulatory Assessment (NSAA) [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  23. Efficacy as measured by hand-held myometry (elbow flexors and knee extensors) [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  24. Efficacy as measured by range of motion in the ankles (ROM) [ Time Frame: 24, 48 weeks ]
    (vamorolone at 2.0mg/kg/day and vamorolone at 6.0 mg/kg/day vs. placebo)- 24 weeks ; (Change from baseline to each of the scheduled study assessment time points for each treatment group up to Week 48)

  25. Safety as measured by serum pharmacodynamic biomarkers by morning cortisol. [ Time Frame: 48 weeks ]
  26. Safety as measured by serum pharmacodynamic biomarkers by levels of fasting glucose. [ Time Frame: 48 weeks ]
  27. Safety as measured by serum pharmacodynamic biomarkers by levels of fasting insulin. [ Time Frame: 48 weeks ]
  28. Safety as measured by serum pharmacodynamic biomarkers by levels of osteocalcin. [ Time Frame: 48 weeks ]
  29. Safety as measured by serum pharmacodynamic biomarkers by levels of CTX1. [ Time Frame: 48 weeks ]
  30. Safety as measured by serum pharmacodynamic biomarkers by levels of P1NP. [ Time Frame: 48 weeks ]
  31. Safety as measured by serum pharmacodynamic biomarkers by levels of differential lymphocyte percentage. [ Time Frame: 48 weeks ]
  32. Extremity Fracture Questionnaire [ Time Frame: 24, 48 weeks ]
  33. Physical examination findings at each of the pretreatment, on treatment, and post treatment assessment time points determined by change from baseline in physical examination findings, with assessment of clinical significance [ Time Frame: 48 weeks ]

Other Outcome Measures:
  1. Parent satisfaction with treatment of vamorolone as measured by the Treatment Satisfaction Questionnaire (TSQM) [ Time Frame: 48 weeks ]
  2. Pediatric Outcome Data Collection Instrument (PODCI) [ Time Frame: 48 weeks ]
  3. Child Behavior Checklist [ Time Frame: 48 weeks ]
  4. PARS III Questionnaire [ Time Frame: 48 weeks ]
  5. Ease of administration of study medication administration questionnaire. [ Time Frame: 48 weeks ]
  6. Blindedness questionnaire. [ Time Frame: 24 weeks ]
    Asks each evaluator to predict the identity of the study medication (vamorolone, prednisone, or placebo) the subject was taking during Treatment Period #1, and to rate on a 4-point scale his/her level of certainty and the reason for the chosen level of certainty.

  7. Exploratory biomarker values for aspects of safety and efficacy [ Time Frame: 24 weeks ]

    Serum biomarkers that have been shown to be gluglucocorticoid-responsive in DMD patients, but not yet bridged to clinical outcomes will be assessed. Specific exploratory biomarkers include: MMP-3, leptin, insulin, IGFBP-5, angiotensinogen, afamin, GHBP, CD23, MDC (CCL22), IL-22BP, lymphotoxin a1/b2, IGFBP-2, Integrin a1b1 (CD49a), MMP-12, Protein C, ANGPT2, FGG, LY9

    (vamorolone at 2.0mg/kg/day and 6.0 mg/kg/day vs. placebo) (vamorolone at 2.0mg/kg/day and 6.0mg/kg/day vs. 0.75 mg/kg/day prednisone)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject's parent(s) or legal guardian(s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures; participants will be asked to give written or verbal assent according to local requirements
  2. Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis of DMD as defined as:

    • Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR
    • Identifiable mutation within the DMD gene (deletion/duplication of one or more exons), where reading frame can be predicted as 'out-of-frame,' and clinical picture consistent with typical DMD, OR
    • Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, other) that is expected to preclude production of the dystrophin protein (i.e., nonsense mutation, deletion/duplication leading to a downstream stop codon), with a clinical picture consistent with typical DMD;
  3. Subject is ≥ 4 years and <7 years of age at time of enrollment in the study;
  4. Subject weighs >13.0 kg and ≤ 39.9 kg at the Screening Visit;
  5. Subject is able to walk independently without assistive devices;
  6. Subject is able to complete the Time to Stand Test (TTSTAND) without assistance in <10 seconds, as assessed at the Screening Visit;
  7. Clinical laboratory test results are within the normal range at the Screening Visit, or if abnormal, are not clinically significant, in the opinion of the Investigator. [Note: Serum gamma glutamyl transferase (GGT), creatinine, and total bilirubin all must be ≤ upper limit of the normal range at the Screening Visit];
  8. Subject has evidence of chicken pox immunity as determined by presence of IgG antibodies to varicella, as documented by a positive test result from the local laboratory at the Screening Visit;
  9. Subject is able to swallow tablets, as confirmed by successful test swallowing of placebo tablets during the Screening Period; and
  10. Subject and parent(s)/guardian(s) are willing and able to comply with scheduled visits, study drug administration plan, and study procedures.

Exclusion Criteria:

  1. Subject has current or history of major renal or hepatic impairment, diabetes mellitus or immunosuppression;
  2. Subject has current or history of chronic systemic fungal or viral infections;
  3. Subject has had an acute illness within 4 weeks prior to the first dose of study medication;
  4. Subject has used mineralocorticoid receptor agents, such as spironolactone, eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium), mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of study medication;
  5. Subject has a history of primary hyperaldosteronism;
  6. Subject has evidence of symptomatic cardiomyopathy [Note: Asymptomatic cardiac abnormality on investigation would not be exclusionary];
  7. Subject is currently being treated or has received previous treatment with oral glucocorticoids or other immunosuppressive agents [Notes: Past transient use of oral or inhaled glucocorticoids or other oral immunosuppressive agents for indication other than DMD for no longer than 3 months cumulative, with last use at least 3 months (or last use at least one month prior for inhaled glucocorticoids) prior to first dose of study medication, will be considered for eligibility on a case-by-case basis. Inhaled and/or topical glucocorticoids prescribed for an indication other than DMD are permitted if last use is at least 4 weeks prior to first dose of study medication or are administered at stable dose beginning at least 4 weeks prior to first dose of study medication, and are anticipated to be used at the stable dose regimen for the duration of the study];
  8. Subject has an allergy or hypersensitivity to the study medication or to any of its constituents;
  9. Subject has used idebenone within 4 weeks prior to the first dose of study medication;
  10. Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the Investigator;
  11. Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator;
  12. Subject is taking (or has taken within 4 weeks prior to the first dose of study medication) herbal remedies and supplements which can impact muscle strength and function (e.g., Co-enzyme Q10, creatine, proglandine, etc);
  13. Subject is taking (or has taken within 3 months prior to the first dose of study medication) any medication indicated for DMD, including Exondys51 and Translarna;
  14. Subject is currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of study medication; or
  15. Subject has previously been enrolled in the study.

Note: Any parameter/test may be repeated at the Investigator's discretion during Screening to determine reproducibility. In addition, subjects may be rescreened if ineligible due to a transient condition which would prevent the subject from participating, such as an upper respiratory tract infection or injury, or if ineligible due to negative anti-varicella IgG antibody test result.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439670


Contacts
Contact: Andrea Smith +1 (412) 436-9139 asmith@trinds.com
Contact: Eric P Hoffman, PhD eric.hoffman@reveragen.com

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kyle Kusmik    720-777-8599    Kyle.kusmik@childrenscolorado.org   
Principal Investigator: Michele Yang, M.D.         
United States, Florida
Nemours Children's Hospital Not yet recruiting
Orlando, Florida, United States, 32827
Contact: Kristin McCrary    407-650-7175    kristin.mccracy@nemours.org   
Principal Investigator: Richard Finkel, M.D.         
United States, North Carolina
Duke Children's Hospital Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Debra Heydt    919-668-2843    debra.heydt@duke.edu   
Principal Investigator: Edward Smith, M.D.         
United States, Virginia
Children's Hospital of Virginia of Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Kathryn O'Hara    804-828-3862    kathryn.ohara@vcuhealth.org   
Principal Investigator: Amy Harper, MD         
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Marissa Robertson    206-987-5457    Marissa.Robertson@seattlechildrens.org   
Principal Investigator: Susan Apkon, M.D.         
Canada, Alberta
Alberta's Children Hospital Not yet recruiting
Calgary, Alberta, Canada, AB T3B 6A8
Contact: Brenda Turley    403-955-3184    Brenda.Turley@ahs.ca   
Principal Investigator: Jean Mah, M.D.         
Sponsors and Collaborators
ReveraGen BioPharma, Inc.
European Union
Cooperative International Neuromuscular Research Group
Newcastle University
University of Pittsburgh
Investigators
Study Chair: Michela Guglieri, M.D. John Walton Muscular Dystrophy Research Centre
Study Chair: Paula Clemens, M.D. University of Pittsburgh

Publications:
Investigator's Brochure, Version 4, Vamorolone (17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione) 4% Oral Suspension, ReveraGen BioPharma, Inc., January 10, 2017.
FDA Draft Guidance for Industry: Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment. June 2015.

Responsible Party: ReveraGen BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT03439670     History of Changes
Other Study ID Numbers: VBP15-004
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ReveraGen BioPharma, Inc.:
Duchenne Muscular Dystrophy
Vamorolone

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents