Trial · NCT05349721
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Assessment of Function (ALS Functional Rating Scale-Revised [ALSFRS-R]) and Survival (CAFS) Rank After 24 Weeks of Treatment (Intention-to-Treat [ITT] 1 Analysis Population) | Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Combined Assessment of Function (ALSFRS-R) and Survival (CAFS) Rank After 24 Weeks of Treatment (ITT2 Analysis Population) | Week 24 | ITT2 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ALSFRS-R Score at Week 24 (ITT1 Analysis Population) | Baseline, Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ALSFRS-R Score at Week 24 (ITT2 Analysis Population) | Baseline, Week 24 | ITT2 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 through Week 24 | Safety set included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Percent Predicted Slow Vital Capacity (SVC) at Week 24 | Baseline, Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | percent predicted SVC | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Modified Norris Scale Total Score at Week 24 | Baseline, Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Survival Rate | Baseline to Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Baseline to Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | months | MEDIAN |
| SECONDARY | Change From Baseline in ALS Assessment Questionnaire (ALSAQ-40) Total Score at Week 24 | Baseline, Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Neurofilament Light Chain (NfL) Activity at Week 24 | Baseline, Week 24 | ITT1 Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and who had a decrease in the ALSFRS-R score of ≤4 points during the Screening Period. | picograms (pg)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve From 0 to Measurable Timepoint (AUC0-t) of Utreloxastat in Plasma | Day 1 and Day 29 | Pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and had at least 1 measurable post-baseline plasma or CSF utreloxastat concentration. 'Number analyzed' = participants evaluable at specified timepoint. | hours*nanograms (ng)/mL | MEAN |
| SECONDARY | Maximum Observed Concentration (Cmax) of Utreloxastat in Plasma | Day 1 and Day 29 | PK analysis set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and had at least 1 measurable post-baseline plasma or CSF utreloxastat concentration. 'Number analyzed' = participants evaluable at specified timepoint. | ng/mL | MEAN |
| SECONDARY | Mean Concentration of Utreloxastat in Cerebrospinal Fluid (CSF) | Day 1 and Day 29 | PK analysis set included all randomized participants who received at least 1 dose of double-blind study drug in the Treatment Period and had at least 1 measurable post-baseline plasma or CSF utreloxastat concentration. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | ng/mL | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05349721/outcomes