AzTrials
AzTrials

Dravet SyndromePhase 3ARGUSNCT04462770

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

A Phase 3 study testing Clemizole HCl in people with Dravet Syndrome, run by Epygenix at 86 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS). Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Dravet Syndrome
What is being tested?
Clemizole HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
86 sitesin 11 countries
Study dates
15 Sep 2020to May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female participants 2 years and older at time of consent.
  • Participant or parent/legally authorized representative (LAR) willing and able to provide written informed consent and assent (if applicable) prior to initiation of any study related procedures.
  • Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:
  • Onset of seizures prior to 18 months of age,
  • Normal development at onset,
  • History of at least one type of countable motor seizure (CMS),
  • Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),
  • Genetic mutation of the SCN1A gene must be documented.

Who cannot join

  • Known sensitivity, allergy, or previous exposure to clemizole HCl.
  • Exposure to any investigational drug or device <90 days prior to Screening or plans to participate in another drug or device trial at any time during the study.
  • Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol [THC] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
  • Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
  • Concurrent use of fenfluramine.
  • Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.

Trial locations and contacts

86 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Krystle Rapchak contact

+1 (312) 847-1289

clinicaltrials@harmonybiosciences.com

Eric Bauer contact

clinicaltrials@harmonybiosciences.com

86 sites in 11 countries

United States31 sites, 18 recruiting

  • University of Michigan- Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Terminated

  • Clinical Integrative Research Center of Atlanta (CIRCA)

    Atlanta, Georgia, 30328

    Withdrawn

  • Child Neurology Consultants of Austin

    Austin, Texas, 78757

    Victoria Henderson, BS, 210-416-4163, Victoria.Henderson@childneurotx.com

    Talitha Durgin, talitha.durgin@childneurotx.com

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Kathryn Lalor, MD, 205-586-4464, klalor@uabmc.edu

    Kathryn Lalor, MD

    Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Terminated

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Samantha Ballard, BSN, RN, CPN, 513-803-3177, samantha.ballard@cchmc.org

    Jessica Michael, jessica.michael@cchmc.org

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Honglian Huang, PhD, 216-445-2366, huangh2@ccf.org

    Elia Pestana Knight, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Withdrawn

  • UT Southwestern/Children's Health

    Dallas, Texas, 75207

    Withdrawn

  • Duke University Health System

    Durham, North Carolina, 27710

    Amanda Fristoe, 919-613-0767, amanda.fristoe@duke.edu

    Muhammad Zafar, MD

    Recruiting

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

    Withdrawn

  • Rare Disease Research FL

    Kissimmee, Florida, 34746

    Terminated

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    Debopam Samanta, MD, 501-364-1850, dsamanta@uams.edu

    Debopam Samanta, MD

    Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

    Terminated

  • Norton Children's Research Institute

    Louisville, Kentucky, 40202

    Katie Harris, 502-629-5820 ext. 50920, katherine.bellamy@louisville.edu

    Ines Roy, ines.roy@nortonhealthcare.org

    Recruiting

  • Neurology Center for Epilepsy and Seizures

    Marlboro, New Jersey, 07746

    Aimee Kinlan, 732-201-6179, Amy.Kinlan@tektonresearch.com

    Amor Mehta, MD

    Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

    Terminated

  • Medical College of Wisconsin, Children's Wisconsin

    Milwaukee, Wisconsin, 53266

    Adriane Mueller, 414-266-7543, admueller@mcw.edu

    Avantika Singh

    Not yet recruiting

  • Science 37

    Morrisville, North Carolina, 27560

    Recruiting

  • Yale School of Medicine - Yale-New Haven Hospital

    New Haven, Connecticut, 06511

    Aline Herlopian, MD

    Recruiting

  • Weill Cornell Medical Center

    New York, New York, 10021

    Terminated

  • Northwell Health - Lenox Hill Hospital

    New York, New York, 10075

    Withdrawn

  • Children's Nebraska

    Omaha, Nebraska, 68114

    Kym Abraham, 402-559-2977, kabraham@unmc.edu

    Malayna Unkel, 402-559-0686

    Recruiting

  • University of California Irvine

    Orange, California, 92868

    Madeline Pak, 714-456-8413, mspak@hs.uci.edu

    Marie Wencel, mwencel@hs.usci.edu

    Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Rashmi Risbud, Mbio, 215-419-3212, risbudr@chop.edu

    Eric Marsh, MD, PhD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Laura Beeler, BS, 801-585-2121, laura.beeler@hsc.utah.edu

    Daniel Ashman, daniel.ashman@hsc.utah.edu

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94158

    Terminated

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Laurie Guidry, RN, 206-987-0058, laurie.guidry@seattlechildrens.org

    Alex Collins, alex.collins@seattlechildrens.org

    Recruiting

  • The Nemours Foundation

    Wilmington, Delaware, 19803

    Terminated

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Tonya Woosley, 336-716-8940, twoosley@wakehealth.edu

    Gautam S Popli, MD, MBA

    Recruiting

  • Pediatric Neurology and Epilepsy Specialists

    Winter Park, Florida, 32789

    Alex Rivera, 407-293-1122 ext. 121, ariveradelvalle@pediatricneurologyandepilepsy.com

    Kathryn Bruner, kathryn.skilesbruner@pediatricneurologyandepilepsy.com

    Recruiting

Other trials in United States

China18 sites, 18 recruiting

  • Beijing Children's Hospital, Capital Medical University - PIN

    Beijing, Beijing Municipality, 100045

    Hui Xiong

    Recruiting

  • Peking University First Hospital - Daxing Campus

    Beijing, Beijing Municipality, 102627

    Yuwu Jiang

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Jianmin Liang

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 10007

    Sai Yang

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Jing Peng

    Recruiting

  • West China Second University Hospital, Sichuan University - Huaxi Campus

    Chengdu, Sichuan, 610041

    Rong Luo

    Recruiting

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610073

    Li Yan

    Recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

    Li Jiang

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Xiaorong Liu

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

    Rong Ai

    Recruiting

  • The Children's Hospital Zhejiang University School of Medicine - Hubin Campus

    Hangzhou, Zhejiang, 310052

    Zhefeng Yuan

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Baomin Li

    Recruiting

  • Jiangxi Provincial Children's Hospital - Donghu Campus

    Nanchang, Jiangxi

    Yong Chen

    Recruiting

  • Children's Hospital of Shanghai - Ludinglu Campus

    Shanghai, Shanghai Municipality, 200062

    Simei Wang

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518000

    Dezhi Cao

    Recruiting

  • Wuhan Children's Hospital

    Wuhan, Hubei, 430015

    Dan Sun

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

    Lin Yang

    Recruiting

  • Xuzhou Children's Hospital

    Xuzhou, Jiangsu, 221006

    Xiaoming Liu

    Recruiting

Other trials in China

India12 sites, 12 recruiting

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

    Jyoti Guruputranavar, +91- 76195 48224, guruputranavarjyoti@gmail.com

    Mahesh Kamate

    Recruiting

  • National Institute of Mental Health and Neurosciences (NIMHANS)

    Bengaluru, Karnataka, 560029

    Ajay Asranna, 91-8943612626, ajayasranna@gmail.com

    Ajay Asranna

    Not yet recruiting

  • Rainbow Children's Hospital

    Hyderabad, Andhra Pradesh, 500034

    Ramesh Konanki, 7386668959, drkonankiramesh@rainbowhospitals.in

    Ramesh Konanki

    Not yet recruiting

  • Yashoda Hospitals Hitec City

    Hyderabad, Andhra Pradesh, 500081

    Shameer Basha Shaik, +91- 9966596459, research2.bnj@rainbowhospitals.in

    Katakam Deepthi, researchneuroscience3@gmail.com

    Not yet recruiting

  • Amrita Institute of Medical Sciences & Research Center

    Kochi, Kerala, 682041

    Deepa Gijesh, +919995184399, deepagijesh@aims.amrita.edu

    Nithya Kumar, nithyankumar2@gmail.com

    Recruiting

  • SRCC Children's Hospital

    Mahālakshmi, Mumbai, 400034

    Vijetha Shetty, +91- 8291207577, drgadgilexecutiveassistant@gmail.com

    Pradnya Gadgil

    Recruiting

  • Jaslok Hospital & Research Centre

    Mumbai, Maharashtra, 400026

    Pradnya Shinde, +919757138607, pradnyashinde2210@gmail.com

    Anita Hegde

    Recruiting

  • Central India Cardiology Hospital and Research Institute

    Nagpur, Maharashtra, 440015

    Krutika Satokar, +919359723117, Krutika@hrapl.in

    Amarjeet Wagh

    Recruiting

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029

    Shailly Katoch, +919878507624, katochshailly@gmail.com

    Sheffali Gulati

    Recruiting

  • KEM Hospital Research Centre

    Pune, Maharashta, 411011

    Aishwarya Patil, +91- 98999476422, aishwaryauttampatil@gmail.com

    Nandan Yardi

    Not yet recruiting

  • Saachi Children's Hospital

    Surat, Gujarat, 395002

    Honey Patel, 73833-33348, honey.patel@visaferesearch.com

    Ritesh Shah

    Recruiting

  • Christian Medical College

    Vellore, Tamil Nadu, 632004

    G Ponezhil, +918124235630, argustrialpnucmc@gmail.com

    Maya Thomas

    Recruiting

Other trials in India

Argentina4 sites, 4 recruiting

  • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

    Buenos Aires

    Walter Silva, 5491138310315, whsilva@fleni.org.ar

    Walter Silva

    Not yet recruiting

  • Conci Carpinella - Santa Rosa N° 748

    Córdoba

    Hector Martinez, 5493517473258, hectorariel_martinez@hotmail.com

    Hector Martinez

    Not yet recruiting

  • Instituto Privado Kremer

    Córdoba

    Carlos Deabato, 0351 3303166, deabatoarg@gmail.com

    Carlos Deabato

    Not yet recruiting

  • Instituto Médico Rivarola (GIEN SRL)

    San Luis

    Pablo Lopez, (54115) 239-6010, pabloadrian.lopez@swissmedical.com.ar

    Pablo Lopez

    Not yet recruiting

Other trials in Argentina

Brazil4 sites, 4 recruiting

  • Hospital Universitário da Universidade Estadual de Campinas - UNICAMP

    Campinas

    Fernando Cendes, (55193) 521-7372, fcendes@unicamp.br

    Fernando Cendes

    Not yet recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

    São José do Rio Preto

    Lucia Neves Marques, 55 17 99608-4244, luciahelenanevesmarques@gmail.com

    Lucia Neves Marques

    Not yet recruiting

  • Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM

    São Paulo

    Laura Maria Guilhoto, (55115) 579-2581, lauragui@gmail.com

    Laura Maria Guilhoto

    Not yet recruiting

  • Instituto de Psiquiatria HC FMUSP

    São Paulo

    Kette Dualibi Ramos Valente, 551126616518, kette.valente@hc.fm.usp.br

    Kette Dualibi Ramos Valente

    Not yet recruiting

Other trials in Brazil

Canada4 sites, 4 recruiting

  • Children's Hospital of Eastern Ontario Research Institute Inc.

    Ottawa, Ontario, K1H 8L1

    Sarah Healy, MSc, 613-737-7600 ext. 1605, shealy@cheo.on.ca

    Aristhana Kathiresu, AKathiresu@cheo.on.ca

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Laura MacDougall, PhD, CCRP, 416-813-7996, laura.macdougall@sickkids.ca

    Elizabeth Donner, MD

    Recruiting

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

    Sarah Iskandarani, MD, 416-603-5800 ext. 5906, sarah.iskandarani@uhn.ca

    Quratulain Zulfiqar, quaratulain.zulfiqar_ali@uhn.ca

    Recruiting

  • UBC Children's Hospital Research Institute

    Vancouver, British Columbia, V6H 3V1

    Dora Xiong, 604-875-2345 ext. 6728, dora.xiong@cw.bc.ca

    Vanessa Diamond, MD, vanessa.diamond@cw.bc.ca

    Recruiting

Other trials in Canada

Georgia3 sites, 3 recruiting

  • Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry

    Tbilisi, 0159

    Tinatin Nadiradze, MD, +995558320502, t.nadiradze@tsmu.edu

    Sophia Bakhtadze, MD

    Recruiting

  • Medi Club Georgia LLC

    Tbilisi, 0160

    Tamar Gachechiladze, MD, +995598357909, tamogachechiladze@yahoo.com

    Gia Melikishvili, MD

    Recruiting

  • Institute of Neurology and Neuropsychology LTD

    Tbilisi, 0186

    Sopiko Digmelashvili, MD, +995551516066, sopikodigmelashvili@gmail.com

    David Kvernadze, MD

    Recruiting

Other trials in Georgia

Poland3 sites, 3 recruiting

  • University Clinical Center in Gdansk, Division of Developmental Neurology

    Gdansk, 80-952

    Angelika Kamińska, +48 58 349 23 31, ankaminska@uck.gda.pl

    Maria Mazuriewicz-Bełdzińska, MD

    Recruiting

  • Medical Centre Plejady

    Krakow, 30-363

    Anna Mackowicz, +48 50 107 68 35, anna.mackowicz@plejady.com.pl

    Marta Żołnowska, MD

    Recruiting

  • Institute of Mother and Child

    Warsaw, 01-211

    Zuzanna Kuczer, +48608338848, zuzanna.kuczer@imid.med.pl

    Elżbieta Stawicka, MD

    Recruiting

Other trials in Poland

United Kingdom3 sites

  • Cardiff and Vale University Health Board

    Cardiff, CF14 4XW

    Active, not recruiting

  • Great Ormond Street Hospital For Children

    London, WC1N 1EH

    Completed

  • Sheffield Children's Hospital

    Sheffield, S102TH

    Completed

Other trials in United Kingdom

Hungary2 sites, 2 recruiting

  • Semmelweis University

    Budapest, 1094

    Andrasne Korodi, +06208258208, Korodi.kata@gmail.com

    Kristof Farkas, MD

    Recruiting

  • University of Debrecen

    Debrecen, 4032

    Monika Bessenyei, MD, +0036709450368, besenyei.monika@med.unideb.hu

    Mónika Bessenyei, MD

    Recruiting

Other trials in Hungary

Spain2 sites, 2 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Angela Fraga, +34633160818, AFraga@santpau.cat

    Marc Alegre, MAlegreH@santpau.cat

    Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid Provincia, 28009

    Nuria Ventosino, +346620708323 ext. 7351, nuria.ventosino@salud.madrid.org

    Victor Soto, MD

    Recruiting

Other trials in Spain

About this study

Official title: A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Read the detailed description

The study consists of an Observational Phase, a Double-blind Phase consisting of a dose titration and a maintenance period and an optional Open-Label Extension (OLE) Phase.

Conditions
Dravet Syndrome
Being tested
Clemizole HCl, Placebo
Keywords
Clemizole hydrochloride, Convulsive seizure, Pediatric epilepsy, Dravet syndrome
Medical subject headings
Epilepsies, Myoclonic, Seizures

What participants receive

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

  • Clemizole HClDrug

    Also called EPX-100

    Clemizole HCl will be administered as an oral solution.

  • PlaceboDrug

    Flavor- and color-matching placebo will be administered as an oral solution.

Study groups in NCT04462770
Study groupRoleWhat they receive
Double-blind Phase: Clemizole HClExperimentalParticipants will receive clemizole HCl twice a day (BID).
Receives: Drug: Clemizole HCl
Double-blind Phase: PlaceboPlacebo comparatorParticipants will receive matching placebo BID.
Receives: Drug: Placebo
OLE Phase: Clemizole HClExperimentalParticipants will receive clemizole HCL BID.
Receives: Drug: Clemizole HCl

What is being measured

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

  1. Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline

    Measured: From Baseline up to Week 16

  2. European Union: Percent Change in CMS-28 in the Maintenance Period Relative to Baseline

    Measured: From Baseline up to Week 16

Secondary outcomes (7)

  1. Percentage of Participants with >=50% reduction in CMS-28 Relative to Baseline

    Measured: From Baseline up to Week 16

  2. Number of Countable Motor Seizure-free Days Relative to Baseline

    Measured: From Baseline up to Week 16

  3. Clinical Global Impression of Improvement - Clinician (CGII-C) Score

    Measured: Week 16

  4. Clinical Global Impression of Improvement - Participant/Caregiver (CGII-P) Score

    Measured: Week 16

  5. Percent Change in All Seizures Relative to Baseline

    Measured: From Baseline up to Week 16

  6. Incidence of Rescue Anti-epileptic Drug (AED) Use Relative to Baseline

    Measured: From Baseline up to Week 16

  7. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Measured: From Baseline up to Week 18

Timeline

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

  1. First posted8 Jul 2020
  2. Study start15 Sep 2020
  3. Primary completionApr 2027 (estimated)
  4. Study completionMay 2029 (estimated)

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
Model description
Patients are randomized 1:1 to clemizole HCl (EPX-100) or placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462770
Sponsor's protocol ID
EPX-100-001
Other IDs
2024-518628-57-00
Acronym
ARGUS
Status last verified
Oct 2026
First submitted
6 Jul 2020
Last updated
29 Oct 2026
Results posted
No
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 Clemizole HCl in people with Dravet Syndrome, run by Epygenix at 86 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, China, India, Argentina, Brazil 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Krystle Rapchak (+1 (312) 847-1289, clinicaltrials@harmonybiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline (time frame: From Baseline up to Week 16). 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 NCT04462770.

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 29 Oct 2026.

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