A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
3 other identifiers
interventional
1,633
17 countries
141
Brief Summary
The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2019
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2020
CompletedResults Posted
Study results publicly available
July 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2021
CompletedJuly 29, 2022
June 1, 2022
12 months
September 12, 2018
June 11, 2021
June 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
2 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
2 Hours Postdose
Secondary Outcomes (20)
Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack
2 Hours Postdose
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks
2 Hours Postdose
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack
24 Hours
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack
48 Hours Postdose
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.
2 Hours Postdose
- +15 more secondary outcomes
Study Arms (9)
100 milligram (mg) Lasmiditan
EXPERIMENTALParticipants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
200 mg Lasmiditan
EXPERIMENTALParticipants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Control 1 Sequence
PLACEBO COMPARATORControl 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Control 2 Sequence
PLACEBO COMPARATORControl 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
EXPERIMENTALParticipants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
200 mg Lasmiditan MEE
EXPERIMENTALParticipants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Control 1 Sequence MEE
PLACEBO COMPARATORControl 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Control 2 Sequence MEE
PLACEBO COMPARATORControl 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Open Label Extension
EXPERIMENTALParticipants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
Interventions
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
- History of disabling migraine for at least 1 year
- Migraine onset before the age of 50 years
- History of 3 to 8 migraine attacks per month (\<15 headache days per month) during the past 3 months
- MIDAS score ≥11
- Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
- Women of child-bearing potential must be using or willing to use a highly effective form of contraception
- Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed
You may not qualify if:
- Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
- History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
- History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
- History of orthostatic hypotension with syncope
- Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
- Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
- History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
- Use of more than 3 doses per month of either opioids or barbiturates
- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
- Pregnant or breast-feeding women
- History of drug or alcohol abuse/dependence within 1 year prior to screening
- Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
- Currently enrolled in any other clinical study involving an investigational product
- Relatives of, or staff directly reporting to, the Investigator
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (141)
Rehabilitation & Neurological Services LLC
Huntsville, Alabama, 35805, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
UCSD Altman Clinical & Translational Research Institute (ACTRI)
La Jolla, California, 92121, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
Ochsner Medical Center - North Shore
Covington, Louisiana, 70433, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303, United States
Nevada Headache Institute
Las Vegas, Nevada, 89113-2237, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Island Neuro Associates,PC
Plainview, New York, 11803, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, United States
Universitätsklinik Innsbruck
Innsbruck, Tyrol, 6020, Austria
KH der Barmherzigen Schwestern Linz BetriebsGesmbH
Linz, Upper Austria, 4010, Austria
Christian-Doppler-Klinik
Salzburg, 5020, Austria
AKH
Vienna, 1090, Austria
Jessa Ziekenhuis
Hasselt, Limburg, 3500, Belgium
Algemeen Ziekenhuis St Jan Brugge
Bruges, 8000, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
CHC MontLĂ©gia
Liège, 4000, Belgium
Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology
Liège, 4020, Belgium
Beijing Tiantan Hospital Affiliated to Capital Medical Univ
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital-Capital Medical University
Beijing, Beijing Municipality, 100053, China
The First Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400030, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Hebei General Hospital
Shijiazhuang, Hebei, 050051, China
First hospital affiliated to Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, 430022, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
The First Affliated Hospital of Suzhou University
Suzhou, Jiangsu, 215000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033, China
Jiangsu Province Hospital
Nanjing, Nanjing, 210029, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shengli Oilfield Central Hospital
Dongying, Shandong, 257034, China
People's hospital of Rizhao
Rizhao, Shandong, 276826, China
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, 20040, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
No 1 Affiliate Hospital of Kunming Medical College
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Baotou Central Hospital
Baotou, China
Peking Union Medical College Hospital
Beijing, 100730, China
Chinese PLA General Hospital
Beijing, 100853, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Neurologicka ambulance, Neurologie Brno s.r.o.
Brno, 616 00, Czechia
Brain-Soultherapy s.r.o
Kladno, 27201, Czechia
DADO MEDICAL, s.r.o.
Prague, 120 00, Czechia
Neurologicka ordinace
Prague, 160 00, Czechia
Neurologicka ambulance Prerov
Přerov, 750 02, Czechia
CCBR-Alborg-DK
Aalborg, 9100, Denmark
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Center for Clinical and Basic Research -CCBR
Vejle, 7100, Denmark
APHM HĂ´pital de la Timone
Marseille, 13385, France
Centre Hospitalier Annecy Genevois - Site d'Annecy
Metz-Tessy, 74374, France
Hopital Lariboisière
Paris, 75475, France
CHU de Rouen Hopital Charles Nicolle
Rouen, 76036, France
CHU St Etienne Hopital Nord
Saint-Etienne, 42000, France
Synexus Clinical Research GmbH
Frankfurt am Main, Hesse, 60313, Germany
DRK-Kliniken Nordhessen
Kassel, Hesse, 34121, Germany
Gemeinschaftspraxis fĂ¼r Neurologie und Psychiatrie
Westerstede, Lower Saxony, 26655, Germany
Praxis Dr. Philipp Stude
Bochum, North Rhine-Westphalia, 44787, Germany
Synexus Clinical Research GmbH
Bochum, North Rhine-Westphalia, 44787, Germany
DataMed Klinische Studien GmbH
Cologne, North Rhine-Westphalia, 50935, Germany
Praxis fĂ¼r Neurologie und Psychiatrie
Essen, North Rhine-Westphalia, 45133, Germany
Synexus Clinical Research GmbH
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Synexus Clinical Research GmbH
Berlin, 12627, Germany
Neurologische Praxis Eppendorf
Hamburg, 20249, Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, 04275, Germany
Valeomed Kft.
Esztergom, KomĂ¡rom-Esztergom, 2500, Hungary
SE Neurologiai Klinika
Budapest, 1083, Hungary
Orszagos Idegtudomanyi Intezet
Budapest, 1145, Hungary
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082, India
Apollo Hospitals International Ltd.
Ahmedabad, Gujarat, 382428, India
Artemis Hospital
Gurgaon, Haryana, 122001, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, 560054, India
Mangala Hospitals & Mangala Kidney Foundation
Mangalore, Karnataka, 575003, India
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
Mumbai, Maharashtra, 400053, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422001, India
Deenanth Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
Gobind Ballabh Pant Hospital
New Delhi, 110002, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Istituto Neurologico Neuromed
Pozzilli, Isernia, 86077, Italy
Ospedale Bellaria
Bologna, 40139, Italy
Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Fondazione Istituto Neurologico Nationale C. Mondino
Pavia, 27100, Italy
Clinical Research Institute S C
Tlalnepantla, Edo de Mex, 54055, Mexico
Clinstile, S.A de C.V
Cuauhtémoc, Federal District, 06700, Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo LeĂ³n, 64060, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo LeĂ³n, 64460, Mexico
Medical Care and Research, S.A. de C.V.
MĂ©rida, YucatĂ¡n, 97070, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000, Mexico
Eci Estudios Clinicos Int.
Puebla City, 72160, Mexico
Centro de AtenciĂ³n e InvestigaciĂ³n Cardiovascular del PotosĂ S.C.
San Luis PotosĂ City, 78200, Mexico
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ, Netherlands
Boerhaave Medisch Centrum
Amsterdam, 1078 VV, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
First Moscow State Medical University n.a. Sechenov
Moscow, 119991, Russia
University Headache Clinic
Moscow, 121467, Russia
Medis Priokskiy
Nizhny Novgorod, 603137, Russia
Saint Petersburg State Medical University n.a. Pavlov I.P.
Saint Petersburg, 197022, Russia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, 39008, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital ClĂnico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47010, Spain
H.C.U. Lozano Blesa
Zaragoza, 50009, Spain
Kantonsspital Luzern
Lucerne, Canton of Lucerne, 6000, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
KopfwehZentrum Hirslanden ZĂ¼rich
Zollikon, Canton of Zurich, 8702, Switzerland
Rehaclinic Bad Zurzach
Bad Zurzach, 5330, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, RG2 0TG, United Kingdom
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ, United Kingdom
Kings College Hospital
London, Greater London, SE5 9RS, United Kingdom
Re-Cognition Health Ltd
London, Greater London, W1G 9JF, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, Greater Manchester, M15 6SX, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, Merseyside, L22 0LG, United Kingdom
Synexus Hexham General Hospital
Hexham, Northumberland, NE46 1QJ, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, South Glamorgan, CF15 9SS, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Strathclyde, G20 0SP, United Kingdom
Re-Cognition Health Ltd
Guildford, Surrey, GU2 7YD, United Kingdom
Re-Cognition Health Ltd
Birmingham, West Midlands, B16 8LT, United Kingdom
Synexus Midlands Clinical Research Center
Birmingham, Wstmid, B15 2SQ, United Kingdom
Related Publications (11)
Komori M, Ozeki A, Tanji Y, Kamiki E, Krege JH, Li LQ, Suzuki S, Shibata M, Takeshima T. Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial. J Headache Pain. 2024 Mar 25;25(1):43. doi: 10.1186/s10194-024-01745-y.
PMID: 38528476DERIVEDBlumenfeld 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.
PMID: 37965170DERIVEDAshina M, Roos C, Li LQ, Komori M, Ayer D, Ruff D, Krege JH. Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial. Cephalalgia. 2023 Apr;43(4):3331024231161745. doi: 10.1177/03331024231161745.
PMID: 36950929DERIVEDZhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.
PMID: 36114949DERIVEDMacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
PMID: 35979677DERIVEDDoty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
PMID: 35779194DERIVEDYu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.
PMID: 35713760DERIVEDKrege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
PMID: 35471625DERIVEDTassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.
PMID: 34742230DERIVEDReuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
PMID: 34644189DERIVEDAshina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.
PMID: 33541117DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 14, 2018
Study Start
June 24, 2019
Primary Completion
June 12, 2020
Study Completion
July 8, 2021
Last Updated
July 29, 2022
Results First Posted
July 2, 2021
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.