AzTrials
AzTrials

SchizophreniaPhase 3NCT03121586

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

A Phase 3 study testing Pimavanserin in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 161 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Pimavanserin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
995 participants
Where
161 sitesin 14 countries
Study dates
Jan 2017to 30 May 2024
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

  • Patient is able to understand and provide signed informed consent
  • Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale
  • Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic
  • If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception
  • The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:
  • Aripiprazole
Show all 23Show fewer
  • Aripiprazole long-acting injectables:
  • Abilify Maintena®
  • Aristada®
  • Asenapine
  • Risperidone
  • Risperidone long-acting injection
  • Olanzapine
  • Paliperidone extended release (ER) (≤9 mg)
  • Paliperidone palmitate
  • Invega Sustenna® (≤156 mg)
  • Invega Trinza® (≤546 mg)
  • Trevicta® (≤350 mg)
  • Xeplion® (≤100 mg)
  • Lurasidone
  • Cariprazine
  • Brexpiprazole
  • Asenapine

Who cannot join

  • Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064)
  • A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
  • Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
  • Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
  • Is taking a medication or drug or other substance that is prohibited according to this protocol
  • Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
  • Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study.
  • Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Trial locations and contacts

161 sites in 14 countries.

161 sites in 14 countries

United States32 sites

  • 153-Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico, 87109

  • 162-Synexus Clinical Research, Inc.

    Atlanta, Georgia, 30328

  • 168-Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • 167-CITrials - Bellflower

    Bellflower, California, 90706

  • 141-Hassman Research Institute

    Berlin, New Jersey, 08009

  • 104-Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • 106-New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • 114-Northwestern University

    Chicago, Illinois, 60611

  • 101-American Medical Research

    Chicago, Illinois, 60612

  • 105-ProScience Research Group

    Culver City, California, 90230

  • 170-Suburban Research Associates

    Downingtown, Pennsylvania, 19335

  • 145-Carolina Behavioral Care

    Durham, North Carolina, 27704

  • 125-Galiz Research

    Hialeah, Florida, 33016

  • 130-Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • 127-University Hills Clinical Research

    Irving, Texas, 75062

  • 140-Synexus Clinical Research, Inc - 140

    Jamaica, New York, 11432

  • 118-Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • 124-Altea Research Institute

    Las Vegas, Nevada, 89102

  • 137-Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • 123-Synergy San Diego

    Lemon Grove, California, 91945

  • 156-Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • 102-Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • 146-Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • 110-Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • 171-Alea Research Institute

    Phoenix, Arizona, 85012

  • 103-Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • 128-Finger Lakes Clinical Research

    Rochester, New York, 14618

  • 111-Woodland Research Northwest, LLC

    Rogers, Arkansas, 72758

  • 115-Psychiatric and Behavioral Solutions LLC

    Salt Lake City, Utah, 84105

  • 164-Artemis Institute for Clinical Research

    San Diego, California, 92103

  • 165-CITrials

    Santa Ana, California, 92705

  • 108-Collaborative Nueroscience Network, LLC

    Torrance, California, 90502

Other trials in United States

Russia24 sites

  • 418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"

    Arkhangelsk, 163530

  • 459-Federal State Budgetary Research Institution "Mental Health Science Center"

    Moscow, 115522

  • 573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.Gannushkin

    Moscow

  • 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"

    Moscow

  • 505-GUZ Lipetsk Regional psychoneurological Hospital #1

    Plekhanovo, Lipetsk Oblast, 399313

  • 419-State municipal healthcare Institution "Leningrad region psychoneurological center"

    Saint Petersburg, 188820

  • 415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"

    Saint Petersburg, 190121

  • 571-St. Petersburg SHI "Psychoneurological Dispensary #10"

    Saint Petersburg, 190121

  • 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology

    Saint Petersburg, 192019

  • 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"

    Saint Petersburg, 192019

  • 465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"

    Saint Petersburg, 192019

  • 495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH

    Saint Petersburg, 192019

  • 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"

    Saint Petersburg, 193167

  • 443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"

    Saint Petersburg, 195112

  • 444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"

    Saint Petersburg, 197341

  • 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov

    Saint Petersburg, 197341

  • 496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov

    Saint Petersburg, 197341

  • 458-State Budget Healthcare Institution "Samara Psychiatric Hospital"

    Saint Petersburg, 443016

  • 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF

    Smolensk, 214019

  • 420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company

    Stavropol, 355000

  • 572-Klinika StoLet" Ltd.

    Tomsk

  • 417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)

    Tonnel’nyy, Stavropol Kray, 357034

  • 466-OOO "Lion-Med"

    Voronezh, 394024

  • 422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"

    Yaroslavl, 150003

Other trials in Russia

Bulgaria22 sites

  • 454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD

    Burgas, 8000

  • 533-State Psychiatric Hospital - Kardzhali, EOOD

    Kardzhali, 6600

  • 532-MHAT "Dr. Hristo Stambolski", EOOD

    Kazanlak

  • 569-State Psychiatric Hospital - Lovech

    Lovech, 5500

  • 406-State Psychiatric Hospital - Pazardzhik AD

    Pazardzhik, 4400

  • 535-UMHAT 'Dr. Georgi Stranski', EAD

    Pleven

  • 586-Medical Center Mentalcare OOD

    Plovdiv, 4004

  • 563-MC-Hipokrat-N E00D

    Plovdiv, 4028

  • 403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry

    Plovdiv

  • 592-Medical center Spectar - Plovdiv EOOD

    Plovdiv

  • 570-Medical Centre "Sveti Naum"

    Sofia, 1113

  • 497-MHC - Sofia, EOOD

    Sofia, 1202

  • 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

    Sofia, 1408

  • 402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia

    Sofia, 1431

  • 405-UMHAT "Alexandrovska" EAD

    Sofia, 1431

  • 568-Medical Center Hera EOOD

    Sofia, 1510

  • 528-Medical Center Intermedica, OOD

    Sofia, 1680

  • 404-MHAT-Targovishte, AD

    Targovishte, 7700

  • 590-State Psychiatric Hospital - Tzarev Brod

    Tsarev Brod

  • 498-DCC "Mladost M" - Varna, OOD

    Varna, 9020

  • 455-Mental Health Center - Veliko Tarnovo EOOD

    Veliko Tarnovo, 5000

  • 401-Mental Health Center-Vratsa EOOD

    Vratsa, 3000

Other trials in Bulgaria

Ukraine19 sites

  • 462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"

    Dnipro, 49005

  • 510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)

    Hlevakha, 08631

  • 433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"

    Kharkiv, 61068

  • 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology

    Kharkiv, 61068

  • 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU

    Kharkiv, 61068

  • 567-CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE

    Kharkiv

  • 461-Kherson Regional Psychiatric Hospital

    Kherson, 73488

  • 507-Main Military Clinical Hospital of MDU

    Kyiv, 01133

  • 447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine

    Kyiv, 04080

  • Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30

    Kyiv, 04080

  • 460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2

    Kyiv, 08631

  • 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30

    Kyiv

  • 564-Regional Clinical Psychiatric Hospital

    Nove

  • 438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"

    Odesa, Oblast, 67513

  • 509-CI Odesa Regional Medical Centre of Mental Health

    Odesa, 65014

  • 508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12

    Smila, 20708

  • 591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry

    Uzhhorod

  • Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"

    Vinnytsia, 21005

  • 432-Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko", Male Department No 14, Female Department No 15, Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept of Psychiatry, Narcology and Psychothera

    Vinnytsia

Other trials in Ukraine

Serbia15 sites

  • 428-Clinical center of Serbia

    Belgrade, 11 000

  • 424-Institute of Mental health

    Belgrade, 11000

  • 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry

    Belgrade, 11000

  • 471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"

    Belgrade, 11000

  • 524-General Hospital Euromedik

    Belgrade, 11000

  • 587-Institute of Mental Health

    Belgrade, 11000

  • 584-Clinic for Psychiatry, Clinical Canter of Serbia

    Belgrade

  • 472-Special Hospital for Psychiatric Diseases "Kovin"

    Kovin, 26220

  • 493-Special Neuropsychiatric Hospital Kovin

    Kovin, 26220

  • 423-Clinical Center Kragujevac

    Kragujevac, 34 000

  • 429-Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac, 34 000

  • 430-Psychiatric Clinic, Clinical Center Kragujevac

    Kragujevac

  • 427-Clinical Center Nis, Clinic of Mental Health

    Niš, 18 000

  • 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"

    Niš

  • 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"

    Novi Kneževac

Other trials in Serbia

Argentina11 sites

  • 610-Clinica Privada Banfield S.A.

    Buenos Aires

  • 625-NOVAIN Neurociencias Group

    Buenos Aires

  • 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM

    Ciudad Autonoma Buenos Aires

  • 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL

    Ciudad Autonoma de Buenos Aire

  • 602-FunDamoS

    Ciudad Autonoma de Buenos Aire

  • 622-Instituto Medico Damic Srl

    Córdoba

  • 624-Centro Especializado en Neurociencias CEN

    Córdoba

  • 626-Sanatorio Prof. Leon S. Morra S.A.

    Córdoba

  • 617-INSA Instituto de Neurociencias San Agustin S.A.

    La Plata

  • 623-Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata

  • 607-Resolution Psicopharmacology Research Institute

    Mendoza

Other trials in Argentina

Spain8 sites

  • 476-FIDMAG Germanes Hospitalaries

    Barcelona, 08830

  • 574-Hospital Clinic de Barcelona

    Barcelona

  • 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos

    Barcelona

  • 475-Hospital Gregorio Marañon

    Madrid, 28007

  • 575-Hospital Universitario 12 de Octubre

    Madrid

  • 494-CSM La Corredoria

    Oviedo, 33011

  • 431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria

    Valladolid, 47016

  • 529-Hospital Provincial de Zamora

    Zamora, 49021

Other trials in Spain

Czechia6 sites

  • 512-NeuropsychiatrieHK s.r.o.

    Hradec Králové, 50341

  • 583-Narodni ustav dusevniho zdravi

    Klecany

  • 519-A-SHINE s.r.o.

    Pilsen, 31200

  • 513-CLINTRIAL s.r.o.

    Prague, 10000

  • 499-MUDr. Tibor Miklos

    Prague, 10600

  • 511-Psychiatrie Ricany s.r.o.

    Říčany, 25101

Other trials in Czechia

Croatia5 sites

  • 536 - Clinic for psychiatry Vrapce

    Zagreb

  • 537 - Clinic for psychiatry Vrapce

    Zagreb

  • 550-Clinic for psychiatry Vrapce

    Zagreb

  • 557 - Clinic for psychiatry Vrapce

    Zagreb

  • 594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika

    Zagreb

Other trials in Croatia

Hungary5 sites

  • 411-ÓBudai Egészségűgyi Centrum Kft

    Budapest, Pest County, 1036

  • 456-Semmelweis University Department of Psychiatry and Psychotherapy

    Budapest, Pest County, 1083

  • 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet

    Budapest, 1135

  • 410-Dr. Máthé és Társa Bt.

    Kalocsa, Bács-Kiskun Megye, 6300

  • 440-PsychoTech Kft.

    Pécs, 7633

Other trials in Hungary

Poland5 sites

  • 525-Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • 502-Przychodnia Srodmiescie Sp. z o. o.

    Bydgoszcz, 85-080

  • 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.

    Gdansk, 80-546

  • 501-Specjalistyczna Praktyka Lekarska Marek Domański

    Lublin, 20-582

  • 578-MSCZ im. Prof. J. Mazurkiewicza

    Pruszków

Other trials in Poland

Lithuania4 sites

  • 483-Romuvos klinika, UAB

    Kaunas, LT-44279

  • 518-Kaunas City Outpatient Clinic, Public Institution

    Kaunas, LT-48259

  • 484-Medical Center Puriena JSC

    Šilutė

  • 517-Zirmunai Mental Health Center, Public Institution

    Vilnius, 09112

Other trials in Lithuania

Canada3 sites

  • Chatham-Kent Clinical Trials Research Ctr

    Chatham, Ontario, N7L1C1

  • 356-Chatham-Kent Clinical Trials Research Ctr

    Chatham, N7L 1C1

  • 351-McGill University Health Ctr Allan Memorial Int.

    Montreal, Quebec, H3A 1A1

Other trials in Canada

Italy2 sites

  • 566-Ospedale San Raffaele (San Raffaele Turro)

    Milan

  • 553-AO Città della Salute e della Scienza di Torino

    Torino

Other trials in Italy

About this study

Official title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Conditions
Schizophrenia
Being tested
Pimavanserin
Medical subject headings
Schizophrenia

What participants receive

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

  • PimavanserinDrug

    Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Study groups in NCT03121586
Study groupRoleWhat they receive
Drug - PimavanserinExperimentalPimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
Receives: Drug: Pimavanserin

What is being measured

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

  1. Treatment Emergent Adverse Events

    Number of patients with treatment emergent adverse events

    Measured: Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).

Timeline

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

  1. First posted20 Apr 2017
  2. Study startJan 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 May 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
995 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121586
Sponsor's protocol ID
ACP-103-035
Other IDs
2016-003435-38, 2016
Status last verified
Jul 2025
First submitted
13 Apr 2017
Last updated
24 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 161 sites in 14 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 23 inclusion and 8 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Russia, Bulgaria, Ukraine, Serbia and 9 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. 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 24 Aug 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?

Treatment Emergent Adverse Events (time frame: Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 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 NCT03121586.

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 24 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in