Amyotrophic Lateral SclerosisPhase 3NCT04248465
An Efficacy and Safety Study of Ravulizumab in ALS Participants
A Phase 3 study testing Ravulizumab in people with Amyotrophic Lateral Sclerosis and ALS, run by Alexion Pharmaceuticals, Inc. at 95 sites in 17 countries.
Trial summary
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 95 sitesin 17 countries
- Study dates
- 30 Mar 2020to 17 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
- ALS onset ≤ 36 months from Screening.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Upright slow vital capacity ≥ 65% predicted at Screening.
- If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
- Body weight ≥ 40 kilograms at Screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
- Dependence on invasive or non-invasive mechanical ventilation.
- Previously or currently treated with a complement inhibitor.
- Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Trial locations and contacts
95 sites in 17 countries.
95 sites in 17 countries
United States34 sites
University of Colorado Anschutz Medical Campus School of Medicine
Aurora, Colorado, 80045
Austin Neuromuscular Center
Austin, Texas, 78756
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
Atrium Health Neuroscience Institute
Charlotte, North Carolina, 28207
University of Chicago Medical Center
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43221
Houston Methodist Neurological Institute-Movement Disorders Clinic
Houston, Texas, 77030
Nerve & Muscle Center of Texas
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Florida at Shands Jacksonville
Jacksonville, Florida, 32209
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Las Vegas Clinic
Las Vegas, Nevada, 89145
University of Kentucky
Lexington, Kentucky, 40536
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Southern California
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Beth Israel Medical Center - PRIME
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
University of California-Irvine
Orange, California, 92868
Stanford University Medical Center
Palo Alto, California, 94304
Barrow Neurological Institute
Phoenix, Arizona, 85013
Neuromuscular Research Center and Clinic
Phoenix, Arizona, 85028
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212
Virginia Commonwealth University, Neurology Clinical and Translational Research Office
Richmond, Virginia, 23298
University of California San Diego Medical Center
San Diego, California, 92093-0949
Norris MDA/ALS Center
San Francisco, California, 94115
University of California San Francisco Medical Center
San Francisco, California, 94143
HonorHealth Research Institute
Scottsdale, Arizona, 85251
Swedish Neuroscience Institute
Seattle, Washington, 98122-4470
University of South Florida
Tampa, Florida, 33612
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456
Japan10 sites
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, Tokyo-To, 113-8519
Chiba University Hospital
Chiba, Chiba, 260-8677
Yoshino Neurology Clinic
Ichikawa-shi, Chiba, 272-0827
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
Toho University Omori Medical Center
Ōta-ku, Tokyo-To, 143-8541
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Keio University Hospital
Shinjuku-Ku, Tokyo-To, 160-8582
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
France8 sites
Hopital Neurologique Pierre Wertheimer
Bron, Rhone, 69677
Hopital Roger Salengro - CHU Lille
Lille, 59037
CHU de Limoges - Hôpital Dupuytren
Limoges, Haute Vienne, 87042
Hôpital de la Timone
Marseille, 13385
Hopital Gui de Chauliac
Montpellier, Herault, 34295
CHU de Nice Hôpital Pasteur 2
Nice, Alpes Maritimes, 06001
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651
CHU Tours - Hôpital Bretonneau
Tours, Indre Et Loire, 37044
Canada7 sites
Heritage Medical Research Centre (HMRC)
Edmonton, Alberta, T6G2S2
Stan Cassidy Center for Rehabilitation
Fredericton, New Brunswick, E3B 0C7
LHSC - University Hospital
London, Ontario, N6A 5A5
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
University Hospital of Quebec-Universite Laval
Québec, Quebec, G1J 1Z4
Royal University Hospital
Saskatoon, Saskatchewan, S7K 0M7
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Italy7 sites
Ospedale San Raffaele
Milan, 20132
ICS Maugeri IRCCS
Milan, 20138
Istituto Auxologico Italiano
Milan, 20149
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, 1355 - 41126
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
University of Turin
Torino, 10126
Germany5 sites
Universitaetsmedizin Goettingen
Goettigen, Lower Saxony, 37099
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitaetsklinikum Jena
Jena, Thuringia, 07749
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital San Rafael
Madrid, 28016
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Australia4 sites
Brain and Mind Centre
Camperdown, New South Wales, 2050
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, 6009
Westmead Hospital
Westmead, New South Wales, 2145
Denmark3 sites
Ålborg Universitets Hospital
Aalborg, 9100
Aarhus University Hospital Department of Neurology
Aarhus, 8200
Bispebjerg Hospital
Copenhagen, 2400
Israel3 sites
Rambam Health Care Center
Haifa, 91096
Hadassah University Hospital - Ein Kerem
Jerusalem, 91120
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Sweden2 sites
Karolinska Trial Alliance (KTA)
Huddinge, 141 86
Norrlands universitetssjukhus
Umeå, 90185
United Kingdom2 sites
The National Hospital for Neurology & Neurosurgery
London, Greater London, WC1N 3BG
Royal Hallamshire Hospital
Sheffield, West Midlands, S10 2JF
About this study
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Being tested
- Placebo, Ravulizumab
- Keywords
- Ravulizumab, ALXN1210, Ultomiris, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
RavulizumabBiological
Also called ALXN1210, Ultomiris
Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Experimental | Participants will receive ravulizumab for the duration of the study. Receives: Biological: Ravulizumab |
| Placebo | Placebo comparator | Participants will receive placebo during the 50-week Randomized Controlled Period of the study, after which they will enter the Open-label Extension Period of the study and switch to receive ravulizumab. Receives: Drug: Placebo; Biological: Ravulizumab |
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) Total Score
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
Measured: Baseline, Week 50
Secondary outcomes (8)
Time To Ventilator Assistance-free Survival
Ventilation Assistance-Free Survival (VAFS) is a composite endpoint of survival and severe and irreversible respiratory decline. The use of VAFS allowed for the collection of survival data that was not impacted by survival prolongation from noninvasive or permanent ventilatory interventions which could prolong life without impacting underlying disease progression.
Measured: Up to Week 50
Change From Baseline In Percent Predicted Slow Vital Capacity
Slow vital capacity measures slow and gradual expulsion of air from the lungs using a spirometer.
Measured: Baseline, Week 50
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Week 156
Change From Baseline In Muscle Strength As Assessed By Handheld Dynamometry
Handheld dynamometry (HHD) is a procedure for quantitative strength testing. Muscle strength testing was performed on prespecified muscles in the upper and lower extremities bilaterally and the force measurements were recorded. Force of measurement is reported in megascores (lower, upper, total). The total megascore is defined as the average of the non-missing ratios over baseline for all the muscles involved. The megascore at baseline is always 100. The range of a potential megascore can not be determined in advance. A megascore >100 indicates more strength compared to baseline.
Measured: Baseline, Week 50
Change From Baseline In Serum Neurofilament Light Chain
Measured: Baseline, Week 50
Change From Baseline in Serum Ravulizumab Concentration Over the Study Duration
Measured: Baseline, Predose at Week 50
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration Over the Study Duration
Measured: Baseline, Predose at Week 50
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1210
Blood samples were collected to evaluate antibody response through development of ADAs.
Measured: Week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Mar 2020
- Primary completion17 Oct 2021
- Study completion17 Oct 2021
Why it stopped: The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.
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.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248465
- Sponsor's protocol ID
- ALXN1210-ALS-308
- Other IDs
- 2019-004619-30, 2019
- Status last verified
- Dec 2022
- First submitted
- 27 Jan 2020
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Genge A, van den Berg LH, Frick G, Han S, Abikoff C, Simmons A, Lin Q, Patra K, Kupperman E, Berry JD. Efficacy and Safety of Ravulizumab, a Complement C5 Inhibitor, in Adults With Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1089-1097. doi: 10.1001/jamaneurol.2023.2851.
PubMed 37695623
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT04248465
- Acronym / sponsor ID
- ALXN1210-ALS-308
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Keywords
- Ravulizumab, ALXN1210, Ultomiris, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, ALS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 10 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
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 |
|---|---|---|
| Ravulizumab | Experimental | Biological: RavulizumabParticipants will receive ravulizumab for the duration of the study. |
| Placebo | Placebo comparator | Drug: Placebo, Biological: RavulizumabParticipants will receive placebo during the 50-week Randomized Controlled Period of the study, after which they will enter the Open-label Extension Period of the study and switch to receive ravulizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
- ALS onset ≤ 36 months from Screening.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Upright slow vital capacity ≥ 65% predicted at Screening.
- If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
Key exclusion criteria (5 listed)
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
- Dependence on invasive or non-invasive mechanical ventilation.
- Previously or currently treated with a complement inhibitor.
- Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
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 |
|---|---|---|
| PlaceboSingle loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight. | Drug | Placebo |
| RavulizumabAlso: ALXN1210, UltomirisSingle loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight. | Biological | Placebo, Ravulizumab |
Primary outcome
Change From Baseline In Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score
Time frame: Baseline, Week 50
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
8 secondary outcomes
Time To Ventilator Assistance-free Survival
Time frame: Up to Week 50
Change From Baseline In Percent Predicted Slow Vital Capacity
Time frame: Baseline, Week 50
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
Time frame: Baseline up to Week 156
Change From Baseline In Muscle Strength As Assessed By Handheld Dynamometry
Time frame: Baseline, Week 50
Change From Baseline In Serum Neurofilament Light Chain
Time frame: Baseline, Week 50
Change From Baseline in Serum Ravulizumab Concentration Over the Study Duration
Time frame: Baseline, Predose at Week 50
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration Over the Study Duration
Time frame: Baseline, Predose at Week 50
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1210
Time frame: Week 50
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37695623Genge A, van den Berg LH, Frick G, Han S, Abikoff C, Simmons A, Lin Q, Patra K, Kupperman E, Berry JD. Efficacy and Safety of Ravulizumab, a Complement C5 Inhibitor, in Adults With Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1089-1097. doi: 10.1001/jamaneurol.2023.2851.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
95 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ravulizumab in people with Amyotrophic Lateral Sclerosis and ALS, run by Alexion Pharmaceuticals, Inc. at 95 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Japan, France, Canada, Italy and 12 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 10 Jan 2023). 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) Total Score (time frame: Baseline, Week 50). 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 NCT04248465, 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 10 Jan 2023.