MELAS, Mitochondrial DNA 3243A>G variant and Associated Phenotypes (MIDD, Multi System Phenotypes, Primary Mitochondrial Disease
Conditions
Brief summary
Change from baseline at Week 52 in the: 1. NeuroQoL Fatigue SF v1 score, Change from baseline at Week 52 in the: 2. Duration of the 5 Times Sit-to-Stand Test (5xSST)
Detailed description
Change from baseline at Week 52 in the: 1. 36-Item Short Form Survey (SF-36): sub-score physical functioning, Change from baseline at Week 52 in the: 2. Fatigue Severity Scale (FSS), Change from baseline at Week 52 in the: 3. Beck Depression Inventory (BDIII) total score, Change from baseline at Week 52 in the: 4. Patient reported global impression of severity (PGI-S), Change from baseline at Week 52 in the: 5. Clinician reported global impression of severity (CGI-S)
Interventions
DRUGMatching placebo (containing microcrystalline cellulose (MCC))
DRUGsonlicromanol.HCl
Sponsors
Khondrion B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 52 in the: 1. NeuroQoL Fatigue SF v1 score, Change from baseline at Week 52 in the: 2. Duration of the 5 Times Sit-to-Stand Test (5xSST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 52 in the: 1. 36-Item Short Form Survey (SF-36): sub-score physical functioning, Change from baseline at Week 52 in the: 2. Fatigue Severity Scale (FSS), Change from baseline at Week 52 in the: 3. Beck Depression Inventory (BDIII) total score, Change from baseline at Week 52 in the: 4. Patient reported global impression of severity (PGI-S), Change from baseline at Week 52 in the: 5. Clinician reported global impression of severity (CGI-S) | — |
Countries
Denmark, France, Germany, Italy, Netherlands
Outcome results
None listed