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Huntingtons DiseasePhase 3NCT03761849

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

A Phase 3 study testing RO7234292 in people with Huntingtons Disease, run by Hoffmann-La Roche at 96 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD) Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Huntingtons Disease
What is being tested?
RO7234292
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
899 participants
Where
96 sitesin 18 countries
Study dates
23 Jan 2019to 24 Mar 2022
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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Manifest HD diagnosis, defined as a DCL score of 4
  • Independence Scale (IS) score >= 70
  • Genetically confirmed disease by direct DNA testing with a CAP score >400
  • Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).

Who cannot join

  • Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug

Trial locations and contacts

96 sites in 18 countries.

96 sites in 18 countries

United States20 sites

  • Dent Neurological Institute

    Amherst, New York, 14226

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Uab Medicine

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113

  • The University of Texas Health Science Center at Houston; McGovern Medical School

    Houston, Texas, 77030

  • Evergreen Health Care Center

    Kirkland, Washington, 98034

  • University of California San Diego

    La Jolla, California, 92037-1337

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Columbia University

    New York, New York, 10032-3725

  • Stanford Univ Medical Center

    Palo Alto, California, 94304

  • SC3 Research Group, Inc

    Pasadena, California, 91105

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of California Davis Medical System

    Sacramento, California, 95817

  • University of Utah Clinical Neurosciences Center

    Salt Lake City, Utah, 84132

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33613

  • Georgetown University; Research Division, Psychiatry

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom11 sites

  • Aberdeen Royal Infirmary; Medical Genectics

    Aberdeen, AB25 2ZD

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital

    Cambridge, CB2 0SP

  • University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences

    Cardiff, CF14 4XW

  • Queen Elizabeth University Hospital Glasgow

    Glasgow, G51 4TF

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • National Hospital For Neurology and Neurosurgery

    London, WC1N 3BG

  • Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine

    Manchester, M13 9WL

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • University Hospital Southampton NHS Foundation Trust

    Southhampton, SO16 6YD

Other trials in United Kingdom

Spain9 sites

  • Hospital Universitario de Badajoz; Servicio de Neurología

    Badajoz, 06080

  • Hospital de Cruces; Servicio de Neurologia

    Barakaldo, Vizcaya, 48903

  • Hospital Clinic Servicio de Neurologia

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

    Barcelona, 08041

  • Hospital Universitario de Burgos. Servicio de Neurología

    Burgos, 09006

  • Hospital Ramon y Cajal; Servicio de Neurologia

    Madrid, 28034

  • Fundacion Jimenez Diaz; Servicio de Neurología

    Madrid, 28040

  • Hospital Universitario Virgen Macarena; Servicio de Neurologia

    Seville, 41009

  • Hospital Universitario la Fe; Servicio de Neurologia

    Valencia, 46026

Other trials in Spain

Germany8 sites

  • Uniklinik RWTH Aachen; Klinik für Neurologie

    Aachen, 52074

  • Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie

    Berlin, 10117

  • St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

    Bochum, 44791

  • German Center for Neurodegenerative Diseases (DZNE)

    Bonn, 53127

  • Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

    Erlangen, 91054

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen

    Lübeck, 23538

  • George-Huntington- Institut GmbH; Technologiepark Münster

    Münster, 48149

  • Universitätsklinikum Ulm; Klinik für Neurologie

    Ulm, 89081

Other trials in Germany

France7 sites

  • CHU Angers, Batiement Larrey 2, Neurologie

    Angers, 49933

  • Hopital Henri Mondor; Service de Neurologie

    Créteil, 94010

  • Hopital Roger Salengro Service de Neurologie

    Lille

  • CHU de la Timone - Hopital d Adultes; Service de Neurologie

    Marseille, 13005

  • Hopital Gui de Chauliac; Neurologie

    Montpellier, 34295

  • Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique

    Paris, 75651

  • CHU toulouse - Hôpital Purpan; Departement de Neurologie

    Toulouse, 31059

Other trials in France

Canada6 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1

  • True North Clinical Research-Halifax

    Halifax, Nova Scotia, B3S 1N2

  • Centre Hospitalier de l?Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0C2

  • Centre for Movement Disorders

    North YORK, Ontario, M3B 2S7

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

  • University of British Columbia Hospital; Division of Neurology

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Italy6 sites

  • IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica

    Bologna, Emilia-Romagna, 40139

  • A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche

    Florence, Tuscany

  • Irccs A.O.U.San Martino Ist; Dinogmi

    Genoa, Liguria, 16132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica

    Milan, Lombardy, 20133

  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia

    Rome, Lazio, 00189

  • IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

Japan5 sites

  • Kuwana City Medical Center

    Mie, 511-0061

  • National Hospital Organization Niigata National Hospital

    Niigata, 945-8585

  • Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.

    Okayama, 700-8558

  • Osaka General Medical Center

    Osaka, 558-8558

  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551

Other trials in Japan

Argentina3 sites

  • Hospital Ramos Mejía

    CABA, C1221ADC

  • INEBA

    Capital Federal, C1192AAX

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

Other trials in Argentina

Australia3 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Royal Melbourne Hospital; Department of Neurology

    Parkville, Victoria, 3050

  • WESTMEAD HOSPITAL; Deparment of Neurology

    Westmead, New South Wales, 2145

Other trials in Australia

New Zealand3 sites

  • Auckland DHB - Neurlogy Department; Neurology Department

    Auckland

  • New Zealand Brain Research Institute

    Christchurch, 8011

  • Wellington Hospital; Department of Neurology

    Wellington, 6021

Other trials in New Zealand

Poland3 sites

  • Szpital Sw. Wojciecha; Oddzial Neurologiczny

    Gdansk, 80-462

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

Other trials in Poland

Russia3 sites

  • ?linical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy

    Kazan', Tatarstan Republic, 420061

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnoyarsk Krai, 660037

  • Research Center of Neurology; Neurology Department #5

    Moskva, Moscow Oblast, 125367

Other trials in Russia

Austria2 sites

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

    Innsbruck, 6020

  • Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

    Salzburg, 5020

Other trials in Austria

Denmark2 sites

  • Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    København Ø, 2100

Other trials in Denmark

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • LUMC

    Leiden, 2333 ZA

Other trials in Netherlands

Switzerland2 sites

  • Universitätsspital Basel; Neurologie

    Basel, 4031

  • Neurozentrum Siloah

    Gümligen, 3073

Other trials in Switzerland

Chile1 site

  • Centro de Trastornos del Movimiento (CETRAM); CETRAM

    Santiago, 9120000

Other trials in Chile

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

Being tested
RO7234292, Placebo
Keywords
HD, RG6042, intrathecal, ASO, antisense oligonucleotide
Medical subject headings
Chorea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7234292Drug

    Also called Tominersen

    Intrathecal injection

  • PlaceboDrug

    Intrathecal injection

Study groups in NCT03761849
Study groupRoleWhat they receive
RO7234292 Q8WExperimentalRO4234292 is administered intrathecally every 8 weeks.
Receives: Drug: RO7234292
RO7234292 Q16WExperimentalRO7234292 is administered intrathecally every 16 weeks. Participants in this arm will also receive placebo at alternate weeks to keep the blind.
Receives: Drug: RO7234292; Drug: Placebo
PlaceboPlacebo comparatorPlacebo will be administered every 8 weeks by IT injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS) Score-Z Score

    cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Word Reading (range, 0-no max value, correctly read colour words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population. A z-score of 0 is the mean, and ±1 is 1 standard deviation from the mean. For cUHDRS, z-scores of each test are summed, whereby a higher cUHDRS score is better (score of -3.06-no max value) and a change of ≥1.2 is a meaningful worsening, shown to track functional decline.

    Measured: Weeks 21 for ODC and 69 for NDC

  2. Change From Baseline in the Total Functional Capacity (TFC) Score

    Total Functional Capacity (TFC) Scores are reported at Weeks 21 and 69. Total Functional Capacity Score ranges from 0 to 13, with a higher score representing better functioning.

    Measured: Weeks 21 for ODC and 69 for NDC

Secondary outcomes (17)

  1. Change From Baseline in Total Motor Score (TMS)

    The TMS score is the sum of the individual motor ratings obtained from administration of the 31-item motor assessment. The score ranges from 0 to 124, with a higher score representing more severe impairment.

    Measured: Weeks 21 for ODC and 69 for NDC

  2. Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores' Least Squares Mean Values

    Symbol Digit Modality Test -SDMT test measures the number of items correctly paired maximum of 110 correct pairs in 90 seconds, more correctly paired items representing less impairment.

    The differences in LS mean ( +/-SE) change from baseline SDMT score between the active groups compared with the placebo group at Weeks 21 and 69 were reported. A negative change from baseline in the SDMT indicates disease progression.

    The Least Square Mean values of Symbol Digit Modality Test Scores are reported below.

    The minimum range for the SDMT scale is 0, indicating highest severity. A max number is not possible as it is a time based task, based on the number of correct answers within a set time frame. There are no validated SDMT score thresholds to indicate the level of HD symptom severity.

    Measured: Weeks 21 for ODC and 69 NDC

  3. Change From Baseline in Stroop Word Reading (SWR) Test Scores' Least Squares Mean Values

    Stroop Word Reading-SWR number of words and colors read correctly is counted, with a higher score indicating better cognitive performance scores. There is no upper limit for SWR as it is a time based task. The lower limit (worst possible) however is 0; higher score is better meaning less severity.

    The differences in LS mean ( +/-SE) change from baseline SWR score between the active groups compared with the placebo group at Weeks 21 and 69 were reported. A negative change from baseline in the SWR indicates disease progression.

    The Least Square Mean values of Stroop Word Reading (SWR) Test Scores are reported below.

    Measured: Weeks 21 for ODC and 69 for NDC

  4. Change From Baseline in the Clinical Global Impression, Severity Scale (CGI-S) Scores' Least Squares Mean Values

    The CGI-S is a single-item measure of current global severity and is completed by the clinician at specified clinic visits. The CGI-S is assessed using an 11-point numeric rating scale (NRS), where higher scores indicate greater severity. Only NDC participants data were reported, all other data were not available.

    CGI-S) Scores range from 0 (not at all severe) to 10 (Extremely severe); lower score is better meaning less severity.

    Measured: Week 69 for NDC Only

  5. Percentage of Patients With a Decrease From Baseline of >=1 Point on the Total Functional Capacity (TFC) Score

    Only NDC participant data are available and reported. Total Functional Capacity-TFC score ranges from 0 to 13, with a higher score representing better functioning.

    In this outcome measure, participants with 1 or higher point score decrease from the Baseline TFC Total Score was considered. The Percentage of these participants with such a change was calculated.

    Measured: Week 69 for NDC only

  6. Percentage of Patients With a Decline From Baseline of >=1.2 Points on the Composite Unified Huntington's Disease Rating Scale-cUHDRS Score

    Only NDC participant data are available and reported. The cUHDRS is comprised of the sum scores of the subscales, score ranges and severities mentioned in the Outcome Measure Description 1 (please see above).

    In this outcome measure, participants with 1.2 or higher point score decrease from the Baseline Composite Unified Huntington's Disease Rating Scale- cUHDRS Total Score was considered. The Percentage of these participants with such a change was calculated.

    cUHDRS lowest (worst) score possible value is -3.06 but no upper limit as it involves SWR; higher score is better meaning less severity.

    Measured: Week 69 for NDC Only

  7. Percentage of Patients With an Unchanged or Improved Score on the Clinical Global Impression, Change Scale Score

    The Clinical Global Impression, Change - CGI-C Scale is a single-item measure of change in global status scale and total scores are summed and reported. The CGI-C has 7 response options: "very much worse," "much worse," "minimally worse," "no change," "minimally improved," "much improved," and "very much improved." "Yes", "No" responses collected and total scores are summed and reported below. Percentage of participants who have unchanged or improved scores from the Baseline CGI-C Scores are calculated and reported here.

    Total CGI-C scores range from 1 (Very much improved) to 7 (Very much worse); lower score is better meaning less severity. Only NDC Arms data were available. Minimum and maximum values are 1 and 7 respectively.

    Measured: Weeks 53 and 69 NDC only

  8. Percentage of Participants With Adverse Events

    Measured: Up to 117 Weeks (29 months)

  9. Change From Baseline in Montreal Cognitive Assessment (MoCA)

    ODC Week 21 and NDC Week 69 data were reportable. Total MOCA scores are reported. The MoCA is a patient-completed assessment used to detect cognitive impairment. It contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment.

    Measured: Up to Week 21 for ODC, Up to Week 69 for NDC

  10. Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    SI-Suicidal Idealation. For ODC, only Treatment Emergent Suicide-Related Events Based on the Columbia-Suicide Severity Rating Scale (CSSRS) are reported. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety (Posner et al. 2011). It maps to the Columbia-Classification Algorithm for Suicide Assessment and meets the criteria listed in the U.S. FDA draft guidance for assessment of suicidality in clinical trials (FDA 2012). The higher scores indicate higher severity

    Measured: For ODC at 13th Month, for NDC at Week 101

  11. Concentration of RO7234292 in Plasma

    Concentration of tominersen in plasma reported

    Measured: Week 21 for ODC and Week 69 for NDC

  12. Trough Concentration of RO7234292 in Cerebrospinal Fluid (CSF)

    Tominersen concentrations in cerebrospinal fluid

    Measured: Week 21 for ODC and Week 69 for NDC

  13. Incidence of Anti-Drug Antibodies (ADAs).

    Data at Weeks 21 and 69 for Old Design and New Design Cohorts are reported respectively. All other timepoints were not evaluable and not meaningful.

    Measured: Week 21 for ODC and Week 69 for NDC

  14. Titer and Antibody Subtype, Determined if ADAs Are Identified

    Titer and Antibody Subtype was not analyzed and there is not data to report due to participants' discontinuation

    Measured: Week 21 for ODC and Week 69 for NDC

  15. Change From Baseline in CSF mHTT Protein Level

    Data to be reported within 12 months after the primary completion.

    Measured: Baseline, Week 101

  16. Change From Baseline in Whole and Regional Brain Volumes, as Detrmined by Structural Magnetic Resonance Imaging (MRI)

    Data reported only for ODC Arms. Analysis of Percent Change from Baseline in Volumetric MRI / BSI at 3 Months reported. Analysis performed using analysis of covariance with covariates of CAP, CAG, Age at Baseline and treatment included.

    Analysis of Change from Baseline in: Caudate Volume (mL)

    Measured: Week 13 for ODC

  17. Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level

    Measured: Week 21 for ODC, Weeks 21 and 69 for NDC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start23 Jan 2019
  3. Primary completion24 Mar 2022
  4. Study completion24 Mar 2022

Resources

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
899 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761849
Sponsor's protocol ID
BN40423
Other IDs
GENERATION HD1
Status last verified
Feb 2024
First submitted
30 Nov 2018
Last updated
1 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lugrin C, Alecci L, Simillion C, Volkova-Volkmar E, Giboin LS, Kinsella FC, McColgan P, Wild EJ, Dorn J. Longitudinal assessment of chorea in Huntington's disease using digital passive monitoring. NPJ Digit Med. 2026 Apr 25;9(1):495. doi: 10.1038/s41746-026-02661-y.

    PubMed 42032152

  • Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

    PubMed 31381524

  • Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001.

    PubMed 30776019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RO7234292 in people with Huntingtons Disease, run by Hoffmann-La Roche at 96 sites in 18 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, United Kingdom, Spain, Germany, France and 13 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 7 Nov 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 the Composite Unified Huntington's Disease Rating Scale (cUHDRS) Score-Z Score (time frame: Weeks 21 for ODC and 69 for NDC). The study lists 2 primary outcomes in all. 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 NCT03761849, which also lists 3 linked publications.

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 1 Mar 2024.

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