AzTrials
AzTrials

Migraine DisordersPhase 3GLADIATORNCT02565186

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

A Phase 3 study testing Lasmiditan in people with Migraine Disorders, run by Eli Lilly and Company at 196 sites in 3 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 is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine Disorders
What is being tested?
Lasmiditan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,171 participants
Where
196 sitesin 3 countries
Study dates
7 Oct 2015to 20 Aug 2019
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

  • Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
  • Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
  • Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
  • Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Who cannot join

  • Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
  • Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

Trial locations and contacts

196 sites in 3 countries.

196 sites in 3 countries

United States182 sites

  • Radiant Research

    Akron, Ohio, 44311

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Primary Care Associates

    Anderson, South Carolina, 29621

  • Radiant Research

    Anderson, South Carolina, 29621

  • Michigan Head, Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Radiant Research

    Atlanta, Georgia, 30328

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • Heartland Research Associates

    Augusta, Kansas, 67010

  • Mile High Primary Care

    Aurora, Colorado, 80014

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

  • FutureSearch Trials

    Austin, Texas, 78731

  • ACRC Trials

    Austin, Texas, 78735

  • Tekton Research, Inc

    Austin, Texas, 78745

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Southview Medical Group

    Birmingham, Alabama, 35205

  • Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • PAB Clinical Research

    Brandon, Florida, 33511

  • West Florissant Internists

    Bridgeton, Missouri, 63044

  • Meridien Research

    Brooksville, Florida, 34601

  • Radiant Research

    Carlsbad, California, 92008

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • ACRC Trials

    Carrollton, Texas, 75010

  • PMG Research of Cary, LLC

    Cary, North Carolina, 27518

  • East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Radiant Research

    Chandler, Arizona, 85224

  • Warner Family Practice

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Medical Research South

    Charleston, South Carolina, 29407

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Radiant Research

    Chicago, Illinois, 60602

  • Michigan Avenue Internists

    Chicago, Illinois, 60604

  • Medical and Procedural Specialists of Illinois

    Chicago, Illinois, 60631

  • eStudySite

    Chula Vista, California, 91911

  • Synexus - US

    Cincinnati, Ohio, 45236

  • IVA Research

    Cincinnati, Ohio, 45245

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Colorado Springs Health Partners, PC

    Colorado Springs, Colorado, 80922

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Synexus - US

    Columbus, Ohio, 43212

  • Radiant Research, Inc.

    Council Bluffs, Iowa, 51503

  • Partners in Clinical Research, LLC

    Cumberland, Rhode Island, 02864

  • FutureSearch Trials

    Dallas, Texas, 75231

  • Radiant Research - Dallas North

    Dallas, Texas, 75231

  • Avail Clinical Research LLC

    DeLand, Florida, 32720

  • Clinical Trials of the Rockies

    Denver, Colorado, 80209

  • Radiant Research

    Edina, Minnesota, 55345

  • Oklahoma City Clinic

    Edmond, Oklahoma, 73034

  • Skyline Medical Center

    Elkhorn, Nebraska, 68022

  • Regional Clinical Research

    Endwell, New York, 13760

  • Evanston Premier Healthcare Research, LLC.

    Evanston, Illinois, 60201

  • Synexus/Clinical Research Advantage

    Evansville, Indiana, 47714

  • Synexus - US

    Evansville, Indiana, 47715

  • Clinical Research West Coast

    Fort Myers, Florida, 33901

  • Fountain Hills Family Practice, P.C.

    Fountain Hills, Arizona, 85268

  • Prairie Fields Family Medicine, PC

    Fremont, Nebraska, 68025

  • Neurological Physicians of Arizona Inc

    Gilbert, Arizona, 85234

  • Thunderbird Internal Medicine

    Glendale, Arizona, 85306

  • Thomas C. Lenzmeier, M.D., P.C

    Glendale, Arizona, 85308

  • Allied Clinical Research

    Gold River, California, 95670

  • Radiant Research

    Greer, South Carolina, 29650

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • Clinical Investigation Specialists Inc

    Gurnee, Illinois, 60031

  • MD Clinical

    Hallandale, Florida, 33009

  • Chase Medical Research, LLC

    Hamden, Connecticut, 06517

  • Diagnostic Center of Medicine

    Henderson, Nevada, 89014

  • Rita B. Chuang, MD LLC

    Henderson, Nevada, 89052

  • Nevada Family Care

    Henderson, Nevada, 89074

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • Goldpoint Clinical Research LLC

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256

  • CNS Research Science, Inc.

    Jamaica, New York, 11432

  • The Center For Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Clinical Investigation Specialists Inc

    Kenosha, Wisconsin, 53144

  • Holston Medical Group Clinical Research

    Kingsport, Tennessee, 37660

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Diagnostic Center of Medicine

    Las Vegas, Nevada, 89117

  • Central Kentucky Research Associates Inc

    Lexington, Kentucky, 40509

  • Associates in Neurology, PSC

    Lexington, Kentucky, 40513

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Meridien Research

    Maitland, Florida, 32751

  • Urban Family Practice Associates, PC

    Marietta, Georgia, 30067

  • Sunstone Medical Research, LLC

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee, 38119

  • Advanced Clinical Research LLC

    Meridian, Idaho, 83642

  • Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Prestige Clinical Research

    Miami, Florida, 33133

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Florida Medical Center and Research, Inc.

    Miami, Florida, 33142

  • The Core Research Associates

    Miami, Florida, 33172

  • Veritas Research Corp

    Miami Lakes, Florida, 33014

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida, 33166

  • Oklahoma City Clinic

    Midwest City, Oklahoma, 73110

  • Coastal Carolina Research Center, Inc.

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research

    Murray, Utah, 84123

  • Nashville Neuroscience Group, Inc.

    Nashville, Tennessee, 37203

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Heartland Research Associates

    Newton, Kansas, 67114

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Harmony Medical Research Institute, Inc

    North Miami Beach, Florida, 33162

  • Comprehensive Psychiatric Care, PC

    Norwich, Connecticut, 06360

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • Oklahoma City Clinic

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida, 32801

  • Compass Research

    Orlando, Florida, 32806

  • Continuum Health Care

    Overland Park, Kansas, 66210

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • Family Practice Specialists Ltd

    Phoenix, Arizona, 85018

  • Central Phoenix Med Clinic LLC

    Phoenix, Arizona, 85020

  • Thunderbird Internal Medicine

    Phoenix, Arizona, 85037

  • Tatum Highlands Medical Associates, PLLC

    Phoenix, Arizona, 85050

  • Radiant Research

    Pinellas Park, Florida, 33781

  • ACRC Trials

    Plano, Texas, 75024

  • Doctors of Internal Medicine

    Plano, Texas, 75093

  • Plano Internal Medicine Associates

    Plano, Texas, 75093

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • Northern California Clinical Research Center

    Redding, California, 96001

  • Anderson Clinical Research

    Redlands, California, 92374

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Harbin Clinic

    Rome, Georgia, 30165

  • Clinical Research Center, LLC

    Royal Palm Beach, Florida, 33411

  • Jean Brown Research

    Salt Lake City, Utah, 84096

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • J. Lewis Research, Inc.

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc.

    Salt Lake City, Utah, 84121

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Radiant Research - San Antonio

    San Antonio, Texas, 78229

  • MacGregor Medical Center

    San Antonio, Texas, 78240

  • California Research Foundation

    San Diego, California, 92103-6204

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Radiant Research

    Santa Rosa, California, 95405

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Radiant Research

    St Louis, Missouri, 63141

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Pinnacle Trials, Inc

    Stockbridge, Georgia, 30281

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Georgia Neurology & Sleep Medicine Associates

    Suwanee, Georgia, 30024

  • Multicare Health System

    Tacoma, Washington, 98405

  • Meridien Research

    Tampa, Florida, 33634

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Arizona Community Physicians

    Tucson, Arizona, 85712

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Radiant Research - Vista CA

    Vista, California, 92083

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • West Bay Clinical Research

    Warwick, Rhode Island, 2886

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates

    Wichita, Kansas, 67205

  • Heartland Research Associates

    Wichita, Kansas, 67207

Other trials in United States

United Kingdom10 sites

  • Synexus Wales Clinical Research Centre

    Cardiff, South Glamorgan, CF15 9SS

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire, PR7 7NA

  • Synexus Midlands Clinical Research Center

    Edgbaston, Birmingham, B15 2SQ

  • Synexus Scotland Clinical Research Centre

    Glasgow, Strathclyde, G20 OSP

  • Synexus Hexham General Hospital

    Hexham, Northumberland, NE46 1QJ

  • Kings College Hospital

    London, Greater London, SE5 9RS

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester, M15 6SX

  • Alverton Practice

    Penzance, Cornwall, TR18 4JH

  • Synexus Ltd

    Reading, Berkshire, RG2 0TG

  • Synexus Merseyside Clinical Research Centre

    Waterloo, Merseyside, L22 0LG

Other trials in United Kingdom

Germany4 sites

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Synexus Clinical Research GmbH

    Frankfurt am Main, Hesse, 60313

  • Synexus Clinical Research GmbH

    Leipzig, Saxony, 04103

  • Gemeinschaftspraxis für Neurologie und Psychiatrie

    Westerstede, Lower Saxony, 26655

Other trials in Germany

About this study

Official title: An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)

This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

Being tested
Lasmiditan
Medical subject headings
Migraine Disorders

What participants receive

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

  • LasmiditanDrug

    Also called LY573144

    oral tablet

Study groups in NCT02565186
Study groupRoleWhat they receive
Lasmiditan 100mgExperimentalParticipants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Receives: Drug: Lasmiditan
Lasmiditan 200mgExperimentalParticipants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Receives: Drug: Lasmiditan

What is being measured

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

  1. Number of Participants With at Least 1 Treatment Emergent Adverse Event

    An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

    A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose

    Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).

    Measured: Up to 12 months

  2. Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose

    MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.

    Measured: Up to 12 months

Timeline

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

  1. First posted1 Oct 2015 (estimated)
  2. Study start7 Oct 2015
  3. Primary completion20 Aug 2019
  4. Study completion20 Aug 2019

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
None (open label)
Enrolment
2,171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565186
Sponsor's protocol ID
16890
Other IDs
H8H-CD-LAHL, 2015-005674-37, COL MIG-305, 2015
Acronym
GLADIATOR
Status last verified
Nov 2019
First submitted
29 Sep 2015
Last updated
25 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.

    PubMed 37965170

  • Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R. Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies. Clin Ther. 2021 Jun;43(6):1066-1078. doi: 10.1016/j.clinthera.2021.04.004. Epub 2021 Aug 6.

    PubMed 34366152

  • Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI. Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain. Curr Med Res Opin. 2021 Jun;37(6):1031-1038. doi: 10.1080/03007995.2021.1903846. Epub 2021 Apr 7.

    PubMed 33784930

  • Clemow DB, Hochstetler HM, Dong Y, Hauck P, Peres MFP, Ailani J. Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine. Postgrad Med. 2021 May;133(4):449-459. doi: 10.1080/00325481.2020.1860619. Epub 2021 Mar 17.

    PubMed 33730977

  • Smith T, Krege JH, Rathmann SS, Dowsett SA, Hake A, Nery ESM, Matthews BR, Doty EG. Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies. Neurol Ther. 2020 Dec;9(2):459-471. doi: 10.1007/s40120-020-00185-5. Epub 2020 May 23.

    PubMed 32447545

  • Lipton RB, Lombard L, Ruff DD, Krege JH, Loo LS, Buchanan A, Melby TE, Buse DC. Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study. J Headache Pain. 2020 Feb 24;21(1):20. doi: 10.1186/s10194-020-01088-4.

    PubMed 32093628

  • Brandes JL, Klise S, Krege JH, Case M, Khanna R, Vasudeva R, Raskin J, Pearlman EM, Kudrow D. Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study). Cephalalgia. 2019 Oct;39(11):1343-1357. doi: 10.1177/0333102419864132. Epub 2019 Aug 21.

    PubMed 31433669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lasmiditan in people with Migraine Disorders, run by Eli Lilly and Company at 196 sites in 3 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 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: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in United States, United Kingdom, Germany. 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 25 Aug 2020). 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?

Number of Participants With at Least 1 Treatment Emergent Adverse Event (time frame: Up to 12 months). 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 NCT02565186, which also lists 7 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 25 Aug 2020.

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