Trial · NCT04054375
Weekly Steroids in Muscular Dystrophy
NCT04054375, Phase 2, Completed, Northwestern University; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Weekly Steroids in Muscular Dystrophy. Trials, record NCT04054375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04054375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Weekly Steroids in Muscular Dystrophy
- NCT number
- NCT04054375
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Limb-girdle Muscular Dystrophy, Becker Muscular Dystrophy
- Interventions
- Prednisone
- First posted
- 2019-08-13
- Last updated
- 2023-09-21
- Results first posted
- 2021-07-08
- Limitations and caveats
Some patients were not able to complete the study visits at end of the study due to COVID-19 and fearing safely coming to our site for visits. This is why many metrics do not have 20 data points. All patients completed the 24 weeks of steroid dosing and adverse event check-in. No participants left the study early.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fasting Glucose | Baseline and 6 months (Final Visit) | mg/dL, 0-unlimited, higher score indicates worse outcome |
| Primary | HbgA1c | Baseline and 6 months (Final Visit) | % , 0-100, higher score indicates worse outcome |
| Primary | Fasting Lipid Profile | Baseline and 6 months (Final Visit) | cholesterol levels - mg/dL, higher levels indicate worse outcomes |
| Primary | Creatine Kinase | Baseline and 6 months (Final Visit) | units/L, 0-unlimited, higher scores indicate worse outcome |
| Primary | Respiratory Changes | Baseline, 6 months | Force Vital Capacity (% of predicted value), decrease in FVC indicates declining respiratory function. |
| Secondary | Functional Assessments - NSAD Change | Baseline, Month 6 | Northstar Assessment for Dysferlinopathy \- score out of 58, range from 0 to 58, higher score indicates greater functional ability. |
| Secondary | 6 Minute Walk Test | Baseline, Month 6 | number of meters walked in 6 minute period. Higher values indicate more motor function. |
| Secondary | 10 Meter Run Timed | Baseline, Month 6 | time in seconds to walk/run 10 meters , less time to run indicates greater motor function |
| Secondary | Brooke Scale Score | Baseline, Month 6 | upper extremity assessment, scoring between 1- 6, lower score indicates more upper extremity function |
| Secondary | Vignos Scale Score | Baseline, Month 6 | Lower extremity assessment, score from 1-10, lower score indicates more function. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fasting Glucose | Baseline and 6 months (Final Visit) | mg/dL | MEAN | |
| PRIMARY | HbgA1c | Baseline and 6 months (Final Visit) | % A1c | MEAN | |
| PRIMARY | Fasting Lipid Profile | Baseline and 6 months (Final Visit) | mg/dL | MEAN | |
| PRIMARY | Creatine Kinase | Baseline and 6 months (Final Visit) | U/L | MEAN | |
| PRIMARY | Respiratory Changes | Baseline, 6 months | % Expected | MEAN | |
| SECONDARY | Functional Assessments - NSAD Change | Baseline, Month 6 | score on a scale | MEAN | |
| SECONDARY | 6 Minute Walk Test | Baseline, Month 6 | meters | MEAN | |
| SECONDARY | 10 Meter Run Timed | Baseline, Month 6 | seconds | MEAN | |
| SECONDARY | Brooke Scale Score | Baseline, Month 6 | scores on a scale | MEAN | |
| SECONDARY | Vignos Scale Score | Baseline, Month 6 | scores on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fasting Glucose | Weekly Steroid | Baseline | 93 | Standard Deviation 2 | mg/dL |
| Fasting Glucose | Weekly Steroid | End | 102 | Standard Deviation 4 | mg/dL |
| HbgA1c | Weekly Steroid | Baseline | 5.2 | Standard Deviation 0.08 | % A1c |
| HbgA1c | Weekly Steroid | End | 5.3 | Standard Deviation 0.09 | % A1c |
| Fasting Lipid Profile | Weekly Steroid | Baseline | 182 | Standard Deviation 10 | mg/dL |
| Fasting Lipid Profile | Weekly Steroid | End | 185 | Standard Deviation 9 | mg/dL |
| Creatine Kinase | Weekly Steroid | Baseline | 1574 | Standard Deviation 269 | U/L |
| Creatine Kinase | Weekly Steroid | End | 1047 | Standard Deviation 171 | U/L |
| Respiratory Changes | Weekly Steroid | Baseline | 80 | Standard Deviation 8 | % Expected |
| Respiratory Changes | Weekly Steroid | End | 79 | Standard Deviation 8 | % Expected |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Weekly Steroid | 20 | |
| Overall Study | COMPLETED | Weekly Steroid | 20 | |
| Overall Study | NOT COMPLETED | Weekly Steroid | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Weekly Steroid | 0 | 20 |
| Total, other adverse events | Weekly Steroid | 0 | 20 |
| Total, serious adverse events | Weekly Steroid | 0 | 20 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04054375
GET https://conductscience.org/api/trials/v1/NCT04054375/results?page=2