Trial · NCT06008249
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival, defined as time to death from any cause or respiratory insufficiency (DRI; defined as tracheostomy or the use of non-invasive ventilation for ≥22 h per day for ≥10 consecutive days) | endpoint or 24 months | A tracheostomy for ventilation is meant here |
| Secondary | Composite endpoint evaluating daily functioning and survival based on the joint model framework of survival and longitudinal ALSFRS-R total scores | endpoint or 24 months | The ALSFRS-R (Amyotrophic Lateral Sclerosis Rating Scale-revised) is a 12 item participant self-report measure that monitors ALS disease progression, where a higher score reflects a better outcome. |
| Secondary | Daily functioning, defined as mean change from baseline in ALSFRS-R total score. | endpoint or 24 months | The ALSFRS-R (Amyotrophic Lateral Sclerosis Rating Scale-revised) is a 12 item participant self-report measure that monitors ALS disease progression, where a higher score reflects a better outcome. |
| Secondary | Respiratory function, defined as mean change from baseline in SVC (%predicted of normal according to the GLI-2012 reference standard) | endpoint or 24 months | Slow vital capacity (SVC) is measured in litres, and as a % of predicted. A higher score reflects a better outcome. |
| Secondary | Quality of life, defined as change from baseline on the EQ-5D Visual Analogue Scale (single-item scale) | endpoint or 24 months | The EQ-5D-5L (EuroQol 5 Dimension 5 Level) questionnaire is a standardised measure of health-related Quality of Life, using a Visual Analogue Scale. A higher score relates to a better outcome |
| Secondary | Quality of life, defined as change from baseline on the EQ-5D | endpoint or 24 months | The EQ-5D-5L (EuroQol 5 Dimension 5 Level) questionnaire is a standardised measure of health-related Quality of Life. A lower score relates to a better outcome |
| Secondary | Neuropsychological status, defined as change from baseline on the ECAS | endpoint or 24 months | ECAS (Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen) is a multidomain assessment questionnaire used in ALS to assess cognitive and behavioural changes where a higher score relates to a better outcome. |
| Secondary | Neuropsychological status, defined as change from baseline on the ALS-FTD-Q. | endpoint or 24 months | ALS-FTD-Q (Amyotrophic Lateral Sclerosis-Frontotemporal Dementia-Questionnaire) is a validated instrument for the screening of behavioral disturbances in ALS. |
| Secondary | Clinical disease stage, defined as mean time spent in each stage of the King's and ALS Milano-Torino staging systems. | endpoint or 24 months | The King's Staging Scale is a clinical staging system defining four stages of ALS assessed by way of a semi-structured interview with the participant. |
| Secondary | Change from baseline in laboratory parameters: Urinary P75ECD (ectodomain of neurotrophin receptor p75), Neurofilament light and heavy chain, Plasma creatinine | endpoint or 24 months | Plasma creatinine is assessed to monitor kidney function |
| Secondary | Tolerability defined as time-to-discontinuation of assigned treatment since randomization | endpoint or 24 months | the number of participants who discontinue study medication will be assessed to assess tolerability |
| Secondary | Safety based on the safety assessments including neurological examinations, clinical laboratory evaluations, vital signs and frequency of adverse events (AEs) or serious adverse events (SAEs). | endpoint or 24 months | (S)AEs will be categorized according to the Common Terminology Criteria for Adverse Events and will be rated for severity and association with study drug. |
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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