Study Stopped
Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
ExpeditionPRO
A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
3 other identifiers
interventional
26
13 countries
193
Brief Summary
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2016
Shorter than P25 for phase_3
193 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
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
July 24, 2018
CompletedOctober 10, 2019
September 1, 2019
11 months
May 2, 2016
May 8, 2018
September 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
Baseline, 24 Months
Secondary Outcomes (16)
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Baseline, 24 Months
Change From Baseline on the Mini Mental Status Examination (MMSE)
Baseline, 24 Months
Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Baseline, 24 Months
Change From Baseline on the Functional Activities Questionnaire (FAQ)
Baseline, 24 Months
Change From Baseline on the Neuropsychiatric Inventory (NPI)
Baseline, 24 Months
- +11 more secondary outcomes
Study Arms (2)
Solanezumab
EXPERIMENTALSolanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
Placebo
EXPERIMENTALPlacebo given IV once every 4 weeks for up to 2 years.
Interventions
Eligibility Criteria
You may qualify if:
- Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
- Scores \<27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
- Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
- Scores \>0 on the Functional Activities Questionnaire (FAQ).
- Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.
You may not qualify if:
- Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
- Has known allergy to humanized monoclonal antibodies.
- Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
- Has screening MRI with results showing \>4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
- Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
- Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (193)
Xenoscience
Phoenix, Arizona, 85004, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
Parexel Early Phase Unit at Glendale
Glendale, California, 91206-4140, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
Desert Valley Research
Rancho Mirage, California, 92270, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94114, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Care Access Research LLC
Santa Clarita, California, 91321, United States
California Neuroscience Research
Sherman Oaks, California, 91403, United States
Care Access Research
Valencia, California, 91355, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Christiana Care Research Institute
Newark, Delaware, 19713, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Compass Research
Orlando, Florida, 32806, United States
Pensacola Research Consultants, Inc.
Pensacola, Florida, 32502, United States
Quantum Laboratories
Pompano Beach, Florida, 33064, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Axiom Research
Tampa, Florida, 33609, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
United Osteoporosis Center
Gainesville, Georgia, 30501, United States
Christie Clinic, LLC
Champaign, Illinois, 61820, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Baptist Health Medical Group
Lexington, Kentucky, 40503, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Maine Neurology
Scarborough, Maine, 04074, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
PharmaSite Research Inc
Baltimore, Maryland, 21208, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844, United States
Donald S Marks
Plymouth, Massachusetts, 02360-4843, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
ClinVest
Bolivar, Missouri, 65613, United States
Clinical Research Professionals
Chesterfield, Missouri, 63141, United States
Millenium Psychiatric Associates LLC
Creve Coeur, Missouri, 63141, United States
St Lukes Hospital
Kansas City, Missouri, 64111, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire, 03060, United States
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, 03801, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Pyramid Clinical Research
Monroe, New Jersey, 08831, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
The Cognitive and Research Center of NJ
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albany Medical College
Albany, New York, 12206, United States
Richmond Behavorial Associates
Staten Island, New York, 10312, United States
Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Insight Clinical Trials
Shaker Heights, Ohio, 44122, United States
Summit Research Network Inc
Portland, Oregon, 97210, United States
Center for Cognitive Health
Portland, Oregon, 97225, United States
Abington Neurological Associates
Abington, Pennsylvania, 19090, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, 19046, United States
Northeastern Pennsylvania Memory & Alzheimer's Center
Plains, Pennsylvania, 18705, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Metrolina Neurological Research Institute
Old Point Station, South Carolina, 29707, United States
Baylor AT&T Memory Center
Dallas, Texas, 75219, United States
Baylor AT&T Memory Center
Dallas, Texas, 75231, United States
FutureSearch Trials
Dallas, Texas, 75231, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Texas Health Services Center - Houston
Houston, Texas, 77054, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Sentara Medical Group
Norfolk, Virginia, 23510, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Evergreen Professional Plaza
Kirkland, Washington, 98034, United States
Dean Foundation for Health Research and Education
Middleton, Wisconsin, 53562, United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Gatineau, J8T 8J1, Canada
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Greenfield Park, J4V 2J2, Canada
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Halifax, B3S1M7, Canada
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Kentville, B4N 4K9, Canada
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London, N6C 0A7, Canada
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Ottawa, KIN 5C8, Canada
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Peterborough, K9H2P4, Canada
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Sherbrooke, J1H1Z1, Canada
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Toronto, M3B 2S7, Canada
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Kuopio, 70210, Finland
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Oulu, 90100, Finland
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Tampere, 33100, Finland
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Turku, 20014, Finland
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Vaasa, 65130, Finland
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Amiens, 80054, France
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Bordeaux, 33076, France
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Bron, 69677, France
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Lille, 59037, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75010, France
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Paris, 75015, France
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Paris, 75651, France
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Rennes, 35033, France
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Strasbourg, 67000, France
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Toulouse, 31059, France
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Chemnitz, 09131, Germany
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Genova, 16132, Italy
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Milan, 20122, Italy
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Milan, 20133, Italy
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Monza, 20052, Italy
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Pavia, 27100, Italy
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Perugia, 06134, Italy
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Pisa, 56126, Italy
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Roma, 00153, Italy
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Roma, 00161, Italy
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Roma, 00179, Italy
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Roma, 00189, Italy
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8655, Japan
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Hachiōji, 193-0998, Japan
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Hyōgo, 673-0848, Japan
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Kamakura, 247-8533, Japan
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Kodaira-shi, 187-8551, Japan
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Kōriyama, 963-8052, Japan
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Kyoto, 607-8113, Japan
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Mitaka-shi, 181-0013, Japan
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Shinjuku-Ku, 160-8582, Japan
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Shizuoka, 424-0911, Japan
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Takamatsu, 760-8557, Japan
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Tokyo, 113-0034, Japan
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Tsu, 514-8507, Japan
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Bialystok, 15-732, Poland
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Bydgoszcz, 85-796, Poland
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Lublin, 20-093, Poland
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Poznan, 30-856, Poland
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Sopot, 81-824, Poland
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Warsaw, 01-697, Poland
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
Cortex, PSC
Las Piedras, 00771, Puerto Rico
University Of Puerto Rico
Rio Piedras, 00936, Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, 00918, Puerto Rico
Latin Clinical Trial Center
San Juan, 00918, Puerto Rico
SomniCare Sleep Institute
San Juan, 00918, Puerto Rico
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Barcelona, 08014, Spain
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Barcelona, 08025, Spain
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Barcelona, 08036, Spain
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Castellon, 12004, Spain
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Donostia / San Sebastian, 20009, Spain
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Getafe, 28905, Spain
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Getxo, 48993, Spain
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Madrid, 28006, Spain
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Plasencia, 10600, Spain
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Salt, 17190, Spain
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Valencia, 46017, Spain
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Valencia, 46026, Spain
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Malmo, 20502, Sweden
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Mölndal, 43141, Sweden
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Stockholm, 113 61, Sweden
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Umeå, 90105, Sweden
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Changhua, 500, Taiwan
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Gwei Shan Township, 333, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 11217, Taiwan
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Zhonghe, 235, Taiwan
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Bath, BA1 3NG, United Kingdom
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Chelsea, W6 8RF, United Kingdom
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Guildford, GU2 7YD, United Kingdom
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London, W1G 9RU, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Scotland, G20 0XA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to pts with prodromal AD as defined by the study protocol. Zero pts were analyzed as no data collected for outcomes.
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
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2016
First Posted
May 3, 2016
Study Start
June 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
October 10, 2019
Results First Posted
July 24, 2018
Record last verified: 2019-09
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.