Trial · NCT02858362
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg Muscles | Baseline, Week 12, Week 24, Week 36 and Week 48 | MRS FF was analysed for vastus lateralis and soleus leg muscles. The endpoints were measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol. |
| Primary | Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg Muscles | Baseline, Week 12, Week 24, Week 36 and Week 48 | MRS WTRT was analysed for the vastus lateralis and soleus leg muscles. The endpoints were measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol. |
| Primary | Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | Pharmacokinetic analysis is presented by cohort due to the use of different formulations. The median pre-dose concentration was derived for each participant and then summarized across participants. |
| Primary | Simulated Maximum Plasma Concentration (Cmax) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | Pharmacokinetic analysis is presented by cohort due to the use of different formulations. |
| Primary | Simulated Average Plasma Concentration (Cav) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3) | Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48 | Pharmacokinetic analysis is presented by cohort due to the use of different formulations. |
| Primary | Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | Day 1 to a maximum of Week 96 | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. |
| Secondary | Change From Baseline in Utrophin Intensity | Baseline, Week 24 and Week 48 | A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. Utrophin intensity was analyzed using a semiautomated quantitative assay on the biopsy samples. A positive change from baseline represents an increase in utrophin expression, no change from baseline represents maintenance of utrophin expression and a negative change from baseline represents a reduction in utrophin expression. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Developmental Heavy Chain Myosin (MHCd) Expression | Baseline, Week 24 and Week 48 | A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. MHCd expression was analyzed using a semiautomated quantitative assay on the biopsy samples. A positive change from baseline represents an increase in MHCd expression, no change from baseline represents maintenance of MHCd expression and a negative change from baseline represents a reduction in MHCd expression. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Muscle Fibre Diameter | Baseline, Week 24 and Week 48 | A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. Muscle fibre diameter was analyzed using a semiautomated quantitative assay on the biopsy samples. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Maximum Inspiratory Pressure (MIP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Maximum Expiratory Pressure (MEP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Peak Expiratory Flow (PEF) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Change From Baseline in Peak Cough Flow (PCF) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Analysis of PCF was planned for Cohort 3 only. |
| Secondary | Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) | Baseline, Week 12, Week 24, Week 36 and Week 48 | Analysis of SNIP was planned for Cohort 3 only. |
| Secondary | Number of Participants That Experienced a Clinically Significant Change in Vital Signs Measurements | Baseline to Week 48 | Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse will be disclosed with the following categories: * All values within 20% of change from baseline (\< 20% change). * At least one value ≥ 20% reduction from baseline, but no increases ≥ 20% from baseline (≥ 20% reduction and no \< 20% increase). * At least one value ≥ 20% increase from baseline, but no reductions ≥ 20% from baseline (≥ 20% Increase and no \< 20% reduction). * At least one value ≥ 20% reduction from baseline and at least one value ≥ 20% increase from baseline (≥ 20% reduction and ≥ 20% increase). Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Number of Participants That Experienced a Clinically Significant in Physical Examination Result | Day 1 to Week 48 | Examinations included: ear, nose and throat, cardiovascular system, pulmonary system, skin, abdomen, neurological system, height and weight. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Number of Participants That Experienced a Potentially Clinically Significant Electrocardiogram Measurements | Baseline to Week 48 | PR interval (PRI), heart rate (HR), QTcF and increase from baseline in QTcF (IQTcF) were summarized categorically. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
| Secondary | Number of Participants That Experienced a Potentially Clinically Significant Echocardiogram Measurement | Baseline, Week 24 and Week 48 | Participants were at rest in a supine position for 10 minutes before the measurements were performed. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol. |
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.
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