Amyotrophic Lateral Sclerosis (ALS)
Conditions
Brief summary
Change in disease progression from baseline through 36 weeks, as measured by ALSFRS-R total score and survival
Detailed description
1. Change in SVC from baseline to Week 36, 2. Change in serum levels of NfL protein from baseline to Week 36, 3. Change in ALSFRS-R total score and scores of various functional items/domains of the ALSFRS-R total score from baseline to Week 36, 4. Change in ALSAQ-40 score from baseline to Week 36, 5. Number of TEAEs and SAEs up to Week 36, 6. Assessment of PK in plasma (baseline, Week 16, and Week 36) and CSF (baseline, Week 16, and Week 36), 7. Change in CSF levels of NfL protein from baseline to Week 36, 8. Time from baseline to the occurrence of death or PAV (>22 hours daily for >7 days) (from baseline through Week 36)
Interventions
DRUGPlacebo will be identical to Usnoflast capsules in terms of size
DRUGshape
DRUGand color.
DRUGUsnoflast
Sponsors
Zydus Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disease progression from baseline through 36 weeks, as measured by ALSFRS-R total score and survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in SVC from baseline to Week 36, 2. Change in serum levels of NfL protein from baseline to Week 36, 3. Change in ALSFRS-R total score and scores of various functional items/domains of the ALSFRS-R total score from baseline to Week 36, 4. Change in ALSAQ-40 score from baseline to Week 36, 5. Number of TEAEs and SAEs up to Week 36, 6. Assessment of PK in plasma (baseline, Week 16, and Week 36) and CSF (baseline, Week 16, and Week 36), 7. Change in CSF levels of NfL protein from baseline to Week 36, 8. Time from baseline to the occurrence of death or PAV (>22 hours daily for >7 days) (from baseline through Week 36) | — |
Outcome results
None listed