Amyotrophic Lateral SclerosisPhase 3ADORENCT05178810
Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis
A Phase 3 study testing FAB122 in people with Amyotrophic Lateral Sclerosis, run by Ferrer Internacional S.A. at 38 sites in 11 countries.
Trial summary
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- FAB122
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 38 sitesin 11 countries
- Study dates
- 18 Oct 2021to 26 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Age 18 - 80 years (both inclusive), male or female;
- Diagnosis of definite, probable, probable laboratory supported or possible ALS as based on the El Escorial and the revised Airlie House diagnostic criteria for ALS;
- Onset of first symptoms* no longer than 24 months prior to randomization; *Date of onset is the date the patient reported one or more of the following symptoms:
- Muscle weakness in limbs
- Speech/swallowing difficulties
- Respiratory symptoms: dyspnea was noticed
- SVC equal to or more than 70% of the predicted normal value for gender, height and age at screening visit;
- Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit;
- Capable of providing informed consent and complying with trial procedures.
Main Exclusion Criteria:
- Diagnosis of Primary Lateral Sclerosis;
- Diagnosis of Frontotemporal Dementia;
- Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease, Alzheimer disease);
- Diagnosis of polyneuropathy;
- Other causes of neuromuscular weakness;
- Have a significant pulmonary disorder not attributed to ALS and/or require treatment interfering with the evaluation of ALS on respiratory function;
- Use of intravenous (IV) edaravone within 6 months of the screening visit;
- Depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at Screening;
- Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation;
- Subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for HIV, hepatitis B or C;
Trial locations and contacts
38 sites in 11 countries.
38 sites in 11 countries
Spain8 sites
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario de Basurto
Bilbao
Hospital San Rafael
Madrid
Hospital Universitario La Paz-Carlos III
Madrid
Hospital Regional Universitario Málaga
Málaga
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Virgen del Rocio
Seville
Hospital Universitario y Politécnico La Fe
Valencia
France7 sites
CHRU de Lille - Hôpital Roger Salengro
Lille
CHU de Limoges - Hôpital Dupuytren
Limoges
Centre Hospitalo-Universitaire La Timone
Marseille
CHU de Montpellier
Montpellier
CHU Nice
Nice
Hôpital de la Salpêtrière
Paris
CHRU de Tours
Tours
Italy7 sites
Azienda Ospedaliera Universitaria Cagliari
Cagliari
Centro Clinico NEMO
Milan
University of Milan Medical School
Milan
University of Torino - Rita Levi Montalcini Department of Neuroscience
Milan
Azienda Ospedaliero Universitaria Di Modena
Modena
Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania "Luigi Vanvitelli"
Naples
University of Padua - Azienda Ospedaliera di Padova
Padua
Germany4 sites
Universitätsmedizin Berlin
Berlin
Universitätsklinikum Carl Gustav Carus
Dresden
Hannover Medical School
Hanover
Universitätsklinikum Ulm
Ulm
United Kingdom4 sites
King's College London
London
Manchester MND care centre
Manchester
John Radcliffe Hospital
Oxford
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Poland3 sites
Centrum Medyczne Neuromed
Bydgoszcz
Linden Medical Centre
Krakow
City Clinic SP. z o. o.
Warsaw
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- FAB122, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAB122Drug
Daily dose 100 mg
PlaceboDrug
Daily dose
| Study group | Role | What they receive |
|---|---|---|
| FAB122 | Experimental | Not described Receives: Drug: FAB122 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score After 48 Weeks.
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
Measured: 48 weeks
Secondary outcomes (18)
Combined Assessment of Function and Survival (CAFS) at 48 and 72 Weeks.
The CAFS (Combined assessment of function and survival) combined information on survival time and ALSFRS-R (ALS Functional Rating Scale-Revised) scores. For this endpoint, each subject's outcome was ranked: the worst subject outcomes received the lowest rank numbers such that a higher CAFS score indicates a better outcome.
CAFS rankings are computed using:
Survival data: Patients who die earlier are ranked lower than those who survive longer.
ALSFRS-R scores: For patients with the same survival duration, ranks are determined by their functional decline (change in ALSFRS-R from baseline).
For this study the range could go from 1 to 302. Better Outcome: Higher CAFS rank, indicating prolonged survival and/or less functional decline.
Worse Outcome: Lower CAFS rank, indicating shorter survival and/or greater functional decline.
Measured: 48 weeks and 72 weeks
Survival Probability
Results are based on the overall survival over 72 weeks of treatment, the result is the survival probability estimated over 72 weeks.
Survival probability is calculated considering time to death, tracheostomy or initiation of non-invasive ventilation for more than 20 hours a day for more than 10 consecutive days, over 72 weeks.
Measured: 72 weeks
Change From Baseline in ALSFRS-R Score After 24 and 72* Weeks
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
Measured: 24 weeks, 72 weeks
The Slope of the Decrease in ALSFRS-R Score Over Time at 24, 48 and 72* Weeks;
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
For this outcome, measures on the ALSFRS-R were used to determine the slope of the decrease.
Measured: 24, 48, 72 weeks
Change From Baseline in ALSFRS-R Score on Bulbar Function (Question 1-3 of the ALSFRS-R) After 24, 48 and 72* Weeks;
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
In this outcome, the Bulbar function (as part of ALSFRS-R) is evaluated, it is related to Speech, Salivation and Swallowing. The maximum score on Bulbar function is 12, and the minimum is 0. Higher score better outcome.
Measured: 24, 48 and 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Fine Motor Function
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
In this outcome, the fine motor function (as part of ALSFRS-R) is evaluated, it is related to Handwriting, Eating and Cutting food, Dressing and hygiene. The maximum score on fine motor function is 12, and the minimum is 0. Higher score better outcome.
Measured: 24, 48 and 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Gross Motor Function
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
In this outcome, the gross motor function (as part of ALSFRS-R) is evaluated, it is related to Climbing stairs, Walking, Rising from a chair. The maximum score on gross motor function is 12, and the minimum is 0. Higher score better outcome.
Measured: 24, 48, 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Respiratory Function
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
In this outcome, the respiratory function (as part of ALSFRS-R) is evaluated, it is related to Dyspnea, Orthopnea, Breathing insufficiency. The maximum score on respiratory function is 12, and the minimum is 0. Higher score better outcome.
Measured: 24, 48, 72 weeks
Time to a 3, 6, 9 and 12 Points Change or Death From Baseline in ALSFRS-R Score Over 72* Weeks;
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
For this outcome, the time a 3, 6, 9 and 12 points change or death from baseline in ALSFRS-R.
Measured: 72 weeks (+/-1 week visit window)
Change in Clinical Staging (King's Staging System and MiToS) Over 72 Weeks
The King's staging system is a simple clinical staging system, which defines 4 stages of ALS. The 1st 3 stages are defined by functional involvement of a region: bulbar, upper limbs, and lower limbs. The number of regions involved gives the stage. Stage 4 is reached if swallowing (4A) or respiratory (4B) difficulty is severe enough to require intervention.
The outcome of this measure shows the number of patients which staging decline of 1 point or more or No decline.
Measured: 72 weeks
Overall Survival: Proportion of Subjects Alive (Survival Rate) After 24, 48 and 72* Weeks;
Measured: 24, 48 and 72* weeks;
Proportion of Subjects Alive and no Tracheostomy, or no Initiation of Non-invasive Ventilation for More Than 20 Hours a Day for More Than 10 Consecutive Days After 24, 48 and 72* Weeks
Measured: 24, 48 and 72* weeks
Change From Baseline in Slow Vital Capacity (SVC, Liters) at 24, 48 and 72* Weeks;
Measured: 24, 48 and 72* weeks
Change From Baseline in the Overall Mega Score for the Hand-held Dynamometer (HHD) at 24, 48 and 72* Weeks.
HHD is a procedure for quantitative strength testing performed in the upper and lower extremities bilaterally. The overall mega score are derived as z-scores of average muscle HHD assessments, percent changes from Baseline are used to derive individual muscle scores.
Muscle strength is expressed as the percent change from baseline: (post-baselinevalue-baselinevalue)/baselinevalue×100(post-baseline value - baseline value) / baseline value \times 100(post-baselinevalue-baselinevalue)/baselinevalue×100. If the baseline value is zero, the data is considered missing.
The HDD mega-score averages strength across four muscle locations. It is calculated by averaging the non-missing transformed values. Maximum muscle strength is then standardized using a z-score, based on data from a healthy population.
Z-score of 0 represents the healthy population mean. Negative z-score value means worse outcome.
Measured: 24, 48 and 72* weeks
Change From Baseline in the Total Score on the ALS Assessment Questionnaire-40-Item (ALSAQ-40) Form at 24, 48 and 72* Weeks;
ALS Assessment Questionnaire-40-Item. The ALSAQ-40 is specifically used to measure the subjective wellbeing of patients with ALS. There are 40 items/questions in the long form, the ALSAQ-40, with 5 discrete scales: physical mobility (10 items), activities of daily living and independence (10 items), eating and drinking (3 items), communication (7 items), and emotional reactions (10 items). Range is from 0 to 100 scale, where 0 indicates the best quality of life and 100 the worst.
Measured: 24, 48 and 72* weeks
Change From Baseline in EuroQoL - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Score 24, 48 and 72* Weeks.
European Quality of Life 5 levels and 5 dimensions is a generic questionnaire of health-related quality of life.
5 Domains: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression.
Scale range is from 0 to 100, being 0 the worst and 100 the best.
Measured: 24, 48 and 72* weeks
Change From Baseline in Visual Analogue Scale (VAS) Score at 24, 48 and 72* Weeks.
The Health-Related Quality of Life (HR-QoL) is a questionnaire using a Visual Analog Scale (VAS) ranging from 0 (bad) to 100 (very good).
Measured: 24, 48 and 72* weeks
Proportion of Subjects With a Change of ≥8, ≥4, and ≥9 for ALS Specific, ALS Non-Specific, and ECAS (Edinburgh Cognitive and Behavioural ALS Screen) Total Score;
The ECAS (Edinburgh Cognitive and behavioural ALS Screen) is a brief multidomain assessment originally designed for people with ALS.
Total Score Range: 0 to 136 points. Higher scores indicate better cognitive function.
For ALS-Specific (Assesses cognitive domains most often affected in ALS) Score Range: 0 to 100 points. Higher scores indicate better cognitive function.
And ALS Non-Specific (Evaluates broader cognitive abilities unrelated to ALS pathology) Score Range: 0 to 36 points. Higher scores indicate better cognitive function.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start18 Oct 2021
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Julius Clinical, Stichting TRICALS Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178810
- Sponsor's protocol ID
- FAB122-CT-2001
- Acronym
- ADORE
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2021
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Wijk IF, Kraneburg L, van Eijk RPA, Veldink JH, van Es MA, Westeneng HJ, van den Berg LH. Prodromal symptoms in amyotrophic lateral sclerosis from the perspective of the patient and of the caregiver. Amyotroph Lateral Scler Frontotemporal Degener. 2026 May;27(3-4):263-273. doi: 10.1080/21678421.2025.2574687. Epub 2025 Oct 25.
PubMed 41137739
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05178810
- Acronym / sponsor ID
- ADORE / FAB122-CT-2001
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Collaborators
- Julius Clinical, Stichting TRICALS Foundation
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAB122 | Experimental | Drug: FAB122 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAB122Daily dose 100 mg | Drug | FAB122 |
| PlaceboDaily dose | Drug | Placebo |
Primary outcome
Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score After 48 Weeks.
Time frame: 48 weeks
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
18 secondary outcomes
Combined Assessment of Function and Survival (CAFS) at 48 and 72 Weeks.
Time frame: 48 weeks and 72 weeks
Survival Probability
Time frame: 72 weeks
Change From Baseline in ALSFRS-R Score After 24 and 72* Weeks
Time frame: 24 weeks, 72 weeks
The Slope of the Decrease in ALSFRS-R Score Over Time at 24, 48 and 72* Weeks;
Time frame: 24, 48, 72 weeks
Change From Baseline in ALSFRS-R Score on Bulbar Function (Question 1-3 of the ALSFRS-R) After 24, 48 and 72* Weeks;
Time frame: 24, 48 and 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Fine Motor Function
Time frame: 24, 48 and 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Gross Motor Function
Time frame: 24, 48, 72 weeks
Change From Baseline ALS Functional Rating Scale - Revised Score - Respiratory Function
Time frame: 24, 48, 72 weeks
Time to a 3, 6, 9 and 12 Points Change or Death From Baseline in ALSFRS-R Score Over 72* Weeks;
Time frame: 72 weeks (+/-1 week visit window)
Change in Clinical Staging (King's Staging System and MiToS) Over 72 Weeks
Time frame: 72 weeks
Overall Survival: Proportion of Subjects Alive (Survival Rate) After 24, 48 and 72* Weeks;
Time frame: 24, 48 and 72* weeks;
Proportion of Subjects Alive and no Tracheostomy, or no Initiation of Non-invasive Ventilation for More Than 20 Hours a Day for More Than 10 Consecutive Days After 24, 48 and 72* Weeks
Time frame: 24, 48 and 72* weeks
Change From Baseline in Slow Vital Capacity (SVC, Liters) at 24, 48 and 72* Weeks;
Time frame: 24, 48 and 72* weeks
Change From Baseline in the Overall Mega Score for the Hand-held Dynamometer (HHD) at 24, 48 and 72* Weeks.
Time frame: 24, 48 and 72* weeks
Change From Baseline in the Total Score on the ALS Assessment Questionnaire-40-Item (ALSAQ-40) Form at 24, 48 and 72* Weeks;
Time frame: 24, 48 and 72* weeks
Change From Baseline in EuroQoL - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Score 24, 48 and 72* Weeks.
Time frame: 24, 48 and 72* weeks
Change From Baseline in Visual Analogue Scale (VAS) Score at 24, 48 and 72* Weeks.
Time frame: 24, 48 and 72* weeks
Proportion of Subjects With a Change of ≥8, ≥4, and ≥9 for ALS Specific, ALS Non-Specific, and ECAS (Edinburgh Cognitive and Behavioural ALS Screen) Total Score;
Time frame: 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41137739van Wijk IF, Kraneburg L, van Eijk RPA, Veldink JH, van Es MA, Westeneng HJ, van den Berg LH. Prodromal symptoms in amyotrophic lateral sclerosis from the perspective of the patient and of the caregiver. Amyotroph Lateral Scler Frontotemporal Degener. 2026 May;27(3-4):263-273. doi: 10.1080/21678421.2025.2574687. Epub 2025 Oct 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FAB122 in people with Amyotrophic Lateral Sclerosis, run by Ferrer Internacional S.A. at 38 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain, France, Italy, Germany, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score After 48 Weeks. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.