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A Study of LY3451838 in Participants With Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498910
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.

Condition or disease Intervention/treatment Phase
Migraine Drug: LY3451838 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3451838 in Adults With Treatment-Resistant Migraine
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3451838
LY3451838 given intravenously (IV)
 Drug: LY3451838
Administered IV
Placebo Comparator: Placebo
Placebo given IV
 Drug: Placebo
Administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, Month 1 ]
    Change from Baseline in the Number of Monthly Migraine Headache Days


Secondary Outcome Measures :
  1. Change from Baseline in the Number of Monthly Headache Days [ Time Frame: Baseline, Month 1 ]
    Change from Baseline in the Number of Monthly Headache Days

  2. Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days [ Time Frame: Month 1 ]
    Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days

  3. Number of Participants with One or More Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline up to 5 Months ]
    Number of Participants with One or More SAEs

  4. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3451838 [ Time Frame: Baseline through Month 1 ]
    PK: AUC of LY3451838

  5. PK: Maximum Observed Drug Concentration (Cmax) of LY3451838 [ Time Frame: Baseline through Month 1 ]
    PK: Cmax of LY3451838


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a diagnosis of migraine with a history of migraine headaches of at least 1 year prior, and migraine onset prior to age 50.
  • Have completed at least 80% of required daily diary entries during the start of the study.
  • Have documentation of previous failure of 2 to 4 standard-of-care migraine preventive medication categories in the past 10 years.
  • Women of child-bearing potential must test negative for pregnancy as indicated by a negative serum pregnancy test and negative urine pregnancy test.
  • Women of child-bearing potential who are abstinent or in a same sex relationship must agree to either remain abstinent or to avoid sexual relationships with males.
  • Women of child-bearing potential who are not abstinent, must agree to use one highly effective method of contraception, or a combination of two effective methods of contraception during the study, as well as 5 months following.

  • Women not of childbearing potential may participate and include those who are: A. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or congenital anomaly; or B. Post-menopausal - defined as either:

    • i. a woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, and a follicle-stimulating hormone greater than (>) 40 multi-international units per milliliter (mIU/mL); or
    • ii. a woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or
    • iii. a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy

Exclusion Criteria:

  • Are currently enrolled in any other clinical study or any other type of medical research judged not to be compatible with this study.
  • Have participated, within the last 30 days or 5-half-lives (whichever is longer), in a clinical study involving any investigational product. If the half-life of the investigational product is unknown, 6 months should have passed prior.
  • Known hypersensitivity or intolerance to monoclonal antibodies or other therapeutic proteins, or to common antihistamines, epinephrine, methyl prednisone or other systemic corticosteroids.
  • Are currently receiving medication or other treatment for prevention of migraine headaches. Participants must have discontinued such medications or treatments at least 2 weeks prior. Botulinum toxin A or B that has been administered in the head or neck area use must be discontinued at least 3 months prior. Nerve blocks or device use (such as transcranial magnetic stimulation or electrical nerve stimulation) in the head or neck area for migraine treatment must be discontinued at least 30 days prior. Anti-calcitonin gene-related peptide (CGRP) antibodies must be discontinued at least 5 half-lives prior.
  • Have previously failed more than 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy (that is, maximum tolerated dose for at least 2 months) and/or safety / tolerability reasons.
  • History of cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, retinal migraine, typical aura without headache, complications of migraine and migraine with brainstem aura (basilar-type migraine).
  • In the 3 months prior, have other types of headache besides migraine, tension type headache, or medication overuse headache (MOH). (In other words, participants can have migraine, tension type headache, or MOH in the 3 months prior, but they cannot have other types of headache in that time).
  • History of head or neck injury within last 6 months.
  • History of traumatic cervical or head injury associated with significant change in the quality or frequency of headaches.
  • Have reading of electrocardiogram (ECG) showing abnormalities considered incompatible with the study.
  • Any liver tests outside the normal range.
  • Evidence of significant active or unstable psychiatric disease.
  • Women who are pregnant or nursing.
  • Participants who have used opioids or barbiturate-containing analgesic >4 days per month for the treatment of pain in each of the past 3 months.
  • History of drug or alcohol abuse/dependence within 1 year.
  • Have a positive urine drug screen for illicit drugs.
  • Are unwilling or unable to comply with the use of data collection devices.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498910


Contacts
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Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, Arizona
21st Century Neurology, a division of Xenoscience Recruiting
Phoenix, Arizona, United States, 85004-0000
Contact    602-265-6500      
Principal Investigator: Stephen Flitman         
United States, Connecticut
New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact    203-914-1900      
Principal Investigator: Peter McAllister         
United States, Florida
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Contact    352-629-5800      
Principal Investigator: Anette V. Nieves         
Emerald Coast Center for Neurological Disorders Recruiting
Pensacola, Florida, United States, 32504
Contact    850-438-1136      
Principal Investigator: David M Bear         
University of South Florida Recruiting
Tampa, Florida, United States, 33612-4799
Contact    813-975-2897      
Principal Investigator: Kavita Kalidas         
United States, Missouri
StudyMetrix Research Recruiting
Saint Peters, Missouri, United States, 63303
Contact    636-387-5100      
Principal Investigator: Timothy R Smith         
Clinvest Research LLC Recruiting
Springfield, Missouri, United States, 65810
Contact    413-883-7889      
Principal Investigator: David Gregory True         
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact    732-244-2299      
Principal Investigator: Ashok K. Patel         
United States, Texas
Texas Neurology, PA Not yet recruiting
Dallas, Texas, United States, 75206
Contact    214-827-3610      
Principal Investigator: Stephen Herzog         
United States, Virginia
Health Research of Hampton Roads Inc Recruiting
Newport News, Virginia, United States, 23606
Contact    757-591-8100      
Principal Investigator: George H Freeman         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04498910    
Other Study ID Numbers: 17124
J1H-MC-LAJB ( Other Identifier: Eli Lilly and Company )
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases