Trial · NCT04138277
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Discontinuation of Study Drug | Entire extension study (mean = 40.5 months on treatment) | Open-label extension (OLE) Safety Population defined as all subjects who took at least one dose of ATB200/AT2221 combination treatment in Study ATB200-07 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in 6-Minute Walk Distance (6MWD) | baseline, Week 208 | Motor function was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 39 subjects in the Treatment Continued Group and 18 subjects in the Treatment Switched Group. | meters | MEAN |
| SECONDARY | Change From Baseline in Sitting % Predicted Forced Vital Capacity (FVC) | baseline, Week 208 | Pulmonary function was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 41 subjects in the Treatment Continued Group and 15 subjects in the Treatment Switched Group. | percent predicted FVC | MEAN |
| SECONDARY | Change From Baseline in Manual Muscle Testing (MMT) Lower Extremity Score | baseline, Week 208 | Muscle strength was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 35 subjects in the Treatment Continued Group and 15 subjects in the Treatment Switched Group. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Total Score for Patient-reported Outcomes Measurement Information System (PROMIS®) - Physical Function | baseline, Week 208 | PROMIS-Physical Function was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 42 subjects in the Treatment Continued Group and 19 subjects in the Treatment Switched Group. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Total Score for PROMIS® - Fatigue | baseline, Week 208 | PROMIS-Fatigue was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 42 subjects in the Treatment Continued Group and 19 subjects in the Treatment Switched Group. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Gait, Stairs, Gower, Chair (GSGC) Test | baseline, Week 208 | GSGC was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 33 subjects in the Treatment Continued Group and 14 subjects in the Treatment Switched Group. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Responses | baseline, Week 208 | EQ-5D-5L was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 42 subjects in the Treatment Continued Group and 19 subjects in the Treatment Switched Group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Overall Physical Well-being (Subject's Global Impression of Change [SGIC], Question 1) | baseline, Week 208 | The SGIC was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 42 subjects in the Treatment Continued Group and 19 subjects in the Treatment Switched Group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Physician's Global Impression of Change (PGIC) Overall Status | baseline, Week 208 | The PGIC was evaluated using the Full Analysis Set (consisting of subjects in the study who had both a valid baseline and at least 1 post-baseline assessment for at least 1 of the main efficacy endpoints). Baseline and Month 208 assessment available for 40 subjects in the Treatment Continued Group and 19 subjects in the Treatment Switched Group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Creatine Kinase (U/L) | baseline, Week 208 | The Full Analysis Set was used in analyses of biomarkers. A total of 40 subjects in the Treatment Continued Group and 18 subjects in the Treatment Switched Group had CK values at Week 208. | percent change from baseline | MEAN |
| SECONDARY | Percent Change From Baseline in Urine Hex4 (mmol/Mol Creatinine) | baseline, Week 208 | The Full Analysis Set was used in analyses of biomarkers. A total of 39 subjects in the Treatment Continued Group and 17 subjects in the Treatment Switched Group had urine hex4 values at Week 208. | percent change from baseline | MEAN |
| SECONDARY | Proportion of Subjects With Positive Anti-drug Antibodies at Baseline and Week 208 | baseline, Week 208 | In the Treatment Continued group, 76 subjects had immunogenicity data at baseline, and 41 subjects had data at Week 208. In the Treatment Switched group, 36 subjects had immunogenicity data at baseline and 20 subjects had data at Week 208. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04138277/outcomes