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Proof of Concept Study to Assess Activity and Safety of SMT C1100 (Ezutromid) in Boys With Duchenne Muscular Dystrophy (DMD)
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Trial · NCT02858362

Results by group126

Each measurement the trial posted, group by group, in the words and numbers it posted.

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OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 12 Change from Baseline1.77995% Confidence Interval 0.939 to 2.620Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 24 Change from Baseline3.91495% Confidence Interval 2.695 to 5.132Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 36 Change from Baseline5.23895% Confidence Interval 3.563 to 6.913Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 48 Change from Baseline7.14295% Confidence Interval 4.866 to 9.417Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 12 Change from Baseline0.61595% Confidence Interval 0.068 to 1.162Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 24 Change from Baseline1.10895% Confidence Interval 0.350 to 1.865Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 36 Change from Baseline2.38495% Confidence Interval 1.287 to 3.481Percentage of fat in the muscle
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 48 Change from Baseline2.58495% Confidence Interval 1.258 to 3.909Percentage of fat in the muscle
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 12 Change from Baseline-0.55995% Confidence Interval -1.190 to 0.072Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 24 Change from Baseline-0.48695% Confidence Interval -1.193 to 0.221Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 36 Change from Baseline-0.84995% Confidence Interval -1.454 to -0.244Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Vastus Lateralis: Week 48 Change from Baseline-0.82295% Confidence Interval -1.673 to 0.028Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 12 Change from Baseline-0.65595% Confidence Interval -1.209 to -0.101Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 24 Change from Baseline-0.86195% Confidence Interval -1.440 to -0.281Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 36 Change from Baseline-0.44795% Confidence Interval -1.085 to 0.190Milliseconds
Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg MusclesCohorts 1 and 2: SMT C1100Soleus: Week 48 Change from Baseline-0.11995% Confidence Interval -0.747 to 0.509Milliseconds
Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)Cohort 1: SMT C1100 Formulation 1SMT C110017Geometric Coefficient of Variation 140ng/mL
Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)Cohort 2: SMT C1100 Formulation 2SMT C110080Geometric Coefficient of Variation 83.1ng/mL
Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)Cohort 1: SMT C1100 Formulation 1DHD 1155Geometric Coefficient of Variation 61ng/mL
Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)Cohort 2: SMT C1100 Formulation 2DHD 1365Geometric Coefficient of Variation 55ng/mL

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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  • 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
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  • 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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