AzTrials
AzTrials

Agitation in Patients With Dementia of the Alzheimer's TypePhase 3NCT03393520

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 211 sites in 11 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 be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
AVP-786
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
601 participants
Where
211 sitesin 11 countries
Study dates
13 Oct 2017to 14 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
  • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
  • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
  • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Who cannot join

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participants with myasthenia gravis

Trial locations and contacts

211 sites in 11 countries.

211 sites in 11 countries

United States93 sites

  • Neurology of Central Florida Rsch Ctr # 803

    Altamonte Springs, Florida, 32714

  • Advanced Research Center, Inc #835

    Anaheim, California, 92805

  • Negron Research Services / Humanity Clinical Research #766

    Aventura, Florida, 33180

  • Insight Clinical Trials LLC #570

    Beachwood, Ohio, 44122

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Neurobehavioral Medicine Group #828

    Bloomfield, Michigan, 48302

  • SFM Clinical Research, LLC #563

    Boca Raton, Florida, 33487

  • Helix Biomedics LLC

    Boynton Beach, Florida, 33436

  • Bradenton Research Center #834

    Bradenton, Florida, 34205

  • Alzheimer Disease Center #804

    Braintree, Massachusetts, 02184

  • Clinical Research of Brandon #838

    Brandon, Florida, 33511

  • ASCLEPES Research Center #806

    Brooksville, Florida, 34613

  • Onyx Clinical Research, LLC

    Caro, Michigan, 48723

  • Trinity Universal Research Associates Site #821

    Carrollton, Texas, 75007

  • Valley Medical Research Site#788

    Centerville, Ohio, 45459

  • MD First Research #767

    Chandler, Arizona, 85286

  • The Neurological Institute #843

    Charlotte, North Carolina, 28204

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • Galen Research Site #550

    Chesterfield, Missouri, 63005

  • Osumc #837

    Columbus, Ohio, 43221

  • ATP Clinical Research, Inc #763

    Costa Mesa, California, 92626

  • DelRicht Research #776

    Covington, Louisiana, 70443

  • Beautiful Minds Clinical Research Center #808

    Cutler Bay, Florida, 33157

  • Texas Neurology #832

    Dallas, Texas, 75206

  • NeuroStudies. Net, LLC

    Decatur, Georgia, 30033

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Science Connections, LLC #814

    Doral, Florida, 33178

  • Core Clinical Research # 772

    Everett, Washington, 98201

  • Precise Research Centers Site #765

    Flowood, Mississippi, 39232

  • Liv Generations of Agritopia / CCT #573

    Gilbert, Arizona, 85296

  • ConSalud Medical Research #773

    Hialeah, Florida, 33012

  • Direct Helpers Research Center # 801

    Hialeah, Florida, 33012

  • New Med Research Inc #812

    Hollywood, Florida, 33020

  • Hawaii Pacific Neuroscience #833

    Honolulu, Hawaii, 96817

  • Bio Pharma Informatic LLC Site #822

    Houston, Texas, 77043

  • Bio Pharma Informatic Inc Site #769

    Houston, Texas, 77084

  • Alphab Global Research #793

    Jupiter, Florida, 33458

  • Katy Neurology #823

    Katy, Texas, 77450

  • Paradigm Clinical Research Centers, Inc.

    La Mesa, California, 91942

  • Sunwise Clinical Research #831

    Lafayette, California, 94549

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33449

  • Meridien Research - Lakeland Site Site #558

    Lakeland, Florida, 33805

  • Zynak Clinical Services

    Lauderdale Lakes, Florida, 33313

  • Adaptive Clinical Research, Inc. Site# 815

    Lauderhill, Florida, 33319

  • Innovative Clinical Research, Inc Site #819

    Lauderhill, Florida, 33319

  • Northpointe Psychiatry #761

    Lewisville, Texas, 75057

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research Institute, Inc. #826

    Lomita, California, 90717

  • Rohun Medical Corporation Site #770

    Long Beach, California, 90805

  • Alliance for Wellness, Inc dba Alliance for Research #789

    Long Beach, California, 90807

  • Wellness Clinical Research #824

    McKinney, Texas, 75071

  • PRX Research Site #825

    Mesquite, Texas, 75149

  • Homestead Associates in Research #797

    Miami, Florida, 33032

  • Premier Clinical Research Institute, Inc. #817

    Miami, Florida, 33122

  • Central Miami Medical Institute # 798

    Miami, Florida, 33125

  • Project4Research #774

    Miami, Florida, 33125

  • City Medical Group RC

    Miami, Florida, 33126

  • Finlay Medical Research Corp #552

    Miami, Florida, 33126

  • First Class Medical Services #807

    Miami, Florida, 33126

  • Miami Jewish Health Systems, Inc. #786

    Miami, Florida, 33137

  • New Horizon Research Center Site #795

    Miami, Florida, 33165

  • Reliant Medical Research, LLC #811

    Miami, Florida, 33165

  • Clinical Research Associates of South Florida

    Miami, Florida, 33172

  • P&S Research, LLC #805

    Miami, Florida, 33175

  • Pharmax Research of South Florida

    Miami, Florida, 33175

  • Research Institute of West Kendall

    Miami, Florida, 33186

  • Crystal Biomedical Research, LLC

    Miami Lakes, Florida, 33014

  • Agility Medical Research, Inc Site #816

    Miami Lakes, Florida, 33016

  • NorthStar Medical Research #778

    Middleburg Heights, Ohio, 44130

  • Bayside Clinical Research

    New Port Richey, Florida, 34655

  • Mid Hudson Medical Research, PLLC #836

    New Windsor, New York, 12553

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Psychiatric Care and Research Center #827

    O'Fallon, Missouri, 63368

  • Newton Clinical Research

    Oklahoma City, Oklahoma, 73102

  • Orenda Research & Consulting LLC #840

    Oklahoma City, Oklahoma, 73170

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Combined Research Orlando #799

    Orlando, Florida, 32807

  • Innovation Medical Research Center #802

    Palmetto, Florida, 33157

  • Havana Research Institute

    Pasadena, California, 91105

  • Liv Generations of Ahwatukee / CCT #784

    Phoenix, Arizona, 85048

  • Quantum Laboratories Site #768

    Pompano Beach, Florida, 33064

  • Neurostudies Inc. Site# 796

    Port Charlotte, Florida, 33952

  • Wasatch Clinical Research, LLC Site #771

    Salt Lake City, Utah, 84107

  • Perseverance Research Center

    Scottsdale, Arizona, 85254

  • VICIS Clinical Research Inc. #777

    Tampa, Florida, 33615

  • Academic Alliance in Dermatology

    Tampa, Florida, 33617

  • JSV Clinical Research Study, Inc. #829

    Tampa, Florida, 33634

  • Medical Advancement Center of Arizona #820

    Tempe, Arizona, 85283

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Oakland Medical Research #762

    Troy, Michigan, 48085

  • IPC Research

    Waukesha, Wisconsin, 53188

  • Five Towns Neurology PC/Village Site #764

    Woodmere, New York, 11598

  • Onyx Clinical Research, LLC

    Youngstown, Ohio, 44505

Other trials in United States

Poland19 sites

  • Śródmieście Przychodnia - Bydgoszcz

    Bydgoszcz

  • Centrum Medyczne Sensemed

    Chorzów

  • Care Clinic #750

    Katowice

  • Wielospecjalistyczna Poradnia Lekarska Synapsis #741

    Katowice

  • Krakowska Akademia Neurologii #740

    Krakow

  • Pratia MCM Kraków #747

    Krakow

  • Medycyna Milorzab #743

    Lodz

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol #757

    Nowa Sól, 67-100

  • Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej

    Plewiska

  • Centrum Medyczne HCP

    Poznan

  • Solumed Centrum Medyczne #753

    Poznan

  • Ośrodek Alzheimerowski #756

    Ścinawa, 59-330

  • RCMed Oddział Sochaczew #510

    Sochaczew, 96-500

  • Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda #508

    Suchy Las, 62-002

  • Centrum Medyczne Euromedis

    Szczecin

  • Przychodnia Specjalistyczna Prosen Site#758

    Warsaw, 01-231

  • Centrum Medyczne NeuroProtect

    Warsaw

  • Centrum Medyczne Pratia Warszawa

    Warsaw

  • ClinHouse Centrum Medyczne #755

    Zabrze, 41-807

Other trials in Poland

Spain19 sites

  • Accellacare Alcobendas #659

    Alcobendas, Aocobendas, 28100

  • Fundació ACE

    Barcelona

  • Fundació Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Universitari Vall d'Hebrón

    Barcelona

  • Hospital Universitario Reina Sofia #647

    Córdoba

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitari de Santa Maria

    Lleida

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro - Majadahonda #658

    Majadahonda, 28222

  • Clínica Universidad de Navarra

    Pamplona

  • Hospital Universitario de Salamanca #656

    Salamanca

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Universitario Virgen Macarena #649

    Seville

  • Hospital Universitario y Politécnico de La Fe

    Valencia

  • Complejo Asistencial de Zamora Hospital Virgen de la Concha #652

    Zamora

  • Hospital Viamed Montecanal #643

    Zaragoza

Other trials in Spain

Czechia14 sites

  • MUDr. Marta Holanová Site# 733

    Brno, 61500

  • Fakultni Nemocnice u sv. Anny v Brne #722

    Brno

  • Clinline Services s.r.0 Psychiatricka ambulance #732

    Hostivice

  • Fakultní Nemocnice Hradec Králové #724

    Hradec Kralové

  • NeuropsychiatrieHK #729

    Hradec Králové

  • Brain-Soultherapy #728

    Kladno

  • Supervize #723

    Kutná Hora

  • A-Shine s.r.o.

    Pilsen

  • Ad71 #727

    Prague

  • Clintrial #720

    Prague

  • INEP Medical s.r.o. Institut Neuropsychiatricke Pece #730

    Prague

  • Neurologicka Ambulance - Forbeli #721

    Prague

  • Neuropsychiatrie #726

    Prague

  • Vestra Clinics #725

    Rychnov nad Kněžnou

Other trials in Czechia

United Kingdom14 sites

  • MAC Clinical Research - Barnsley Site #671

    Barnsley

  • Research Institute for the Care of Older People

    Bath

  • Belfast Health and Social Care Trust

    Belfast

  • MAC Clinical Research - Blackpool

    Blackpool

  • MAC Clinical Research - Cannock #672

    Cannock

  • MAC Clinical Research - Leeds

    Leeds

  • Re:Cognition Health - London

    London

  • South London and Maudsley NHS Foundation Trust

    London

  • MAC Clinical Research - Manchester

    Manchester

  • Northamptonshire Healthcare NHS Foundation Trust #682

    Northampton

  • MAC Clinical Research - Liverpool

    Prescot

  • Southern Health NHS Foundation Trust #679

    Southampton

  • Avon and Wiltshire Mental Health Partnership NHS Trust

    Swindon

  • North West Boroughs Healthcare NHS Foundation Trust #685

    Warrington

Other trials in United Kingdom

Hungary13 sites

  • Dr. Kenessey Albert Kórház-Rendelőintézet

    Balassagyarmat

  • Semmelweis Egyetem Site #595

    Budapest, 1083

  • Semmelweis Egyetem

    Budapest

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak #586

    Budapest

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen

  • Valeomed Egeszsegugyi es Szolgaltato Kft

    Esztergom

  • Petz Aladár Egyetemi Oktató Kórház Site# 594

    Győr, 9024

  • Dr. Mathe es Tarsa Beteti Tarsasa Site #593

    Kalocsa, 6300

  • CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság

    Miskolc

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza

  • PsychoTech #580

    Pécs

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár

Other trials in Hungary

Bulgaria12 sites

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

    Pleven

  • Medical Center Hipokrat-N EOOD

    Plovdiv

  • Center for Mental Health - Ruse

    Rousse

  • Mental Health Centre Prof.Nikola Shipkovenski #713

    Sofia, 1000

  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD #710

    Sofia, 1408

  • First Multiprofile Hospital for Active Treatment Sofia

    Sofia

  • Medical Center Stimul

    Sofia

  • Medical Center Sveti Naum #707

    Sofia

  • University Multiprofile Hospital for Active Treatment Alexandrovska

    Sofia

  • Diagnostic-consultative center Mladost-М Varna OOD #711

    Varna, 3020

  • Medica Plus Medical Center #705

    Veliko Tarnovo

  • Mental Health Center Site #712

    Vratsa, 3000

Other trials in Bulgaria

Italy10 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia

  • Centro San Giovanni di Dio - Fatebenefratelli

    Brescia

  • Università degli studi G.D'Annunzio Chieti Pescara

    Chieti

  • Azienda Ospedaliero - Universitaria Careggi #610

    Florence

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

  • Azienda Ospedaliera San Gerardo di Monza

    Monza

  • Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi

    Ponderano

  • Azienda Ospedaliera Sant'Andrea #606

    Roma

  • Fondazione Policlinico Tor Vergata #609

    Roma

  • Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico

    Roma

Other trials in Italy

France8 sites

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen

  • Centre Hospitalier de Calais

    Calais

  • Centre Hospitalier Universitaire Dijon Bourgogn #536

    Dijon

  • Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec #537

    Nantes, 44093

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord #535

    Saint-Etienne

  • Centre Hospitalier Universitaire Toulouse - Casselardit Ancely #533

    Toulouse

  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy

Other trials in France

South Africa6 sites

  • ACF Neurological Services

    Cape Town

  • Cape Trial Centre #621

    Cape Town

  • Flexivest Fourteen Research Centre #620

    Cape Town

  • Apollo Clinical Research #623

    Johannesburg

  • Medical and Dental Centre #625

    Rosebank

  • Dr. Chisto Carel Coetzee

    Umhlanga

Other trials in South Africa

Australia3 sites

  • Australian Alzheimer's Research Foundation

    Nedlands

  • Neuro Trials Victoria Pty Ltd

    Noble Park

  • The Alfred Hospital

    Parkville

Other trials in Australia

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

Read the detailed description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.

Approximately 550 participants will be enrolled at approximately 90 centers worldwide.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Being tested
Placebo, AVP-786
Keywords
Agitation, Dementia of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate
Medical subject headings
Psychomotor Agitation, Alzheimer Disease

What participants receive

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

  • PlaceboDrug

    oral capsules

  • AVP-786Drug

    oral capsules

Study groups in NCT03393520
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Receives: Drug: Placebo
AVP-786; Dose 1ExperimentalParticipants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Receives: Drug: AVP-786
AVP-786; Dose 2ExperimentalParticipants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Receives: Drug: AVP-786

What is being measured

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

  1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

    Measured: Baseline; Week 12

Secondary outcomes (1)

  1. Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score

    Measured: Baseline; Week 12

Timeline

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

  1. First posted8 Jan 2018
  2. Study start13 Oct 2017
  3. Primary completion17 Nov 2023
  4. Study completion14 Dec 2023

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
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03393520
Sponsor's protocol ID
17-AVP-786-305
Other IDs
2017-001339-38, 2017
Status last verified
Nov 2024
First submitted
3 Jan 2018
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AVP-786 in people with Agitation in Patients With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 211 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?

The sponsor lists 6 inclusion and 4 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Poland, Spain, Czechia, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score (time frame: Baseline; Week 12). 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 NCT03393520.

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 20 Nov 2024.

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