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Migraine HeadachePhase 2NCT01625988

A Study of LY2951742 in Participants With Migraine

A Phase 2 study testing LY2951742 in people with Migraine Headache, run by Eli Lilly and Company at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Headache
What is being tested?
LY2951742
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
37 sitesUnited States
Study dates
28 Jun 2012to 18 Sep 2013
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
  • Women of child-bearing potential (not surgically sterile or at least 1 year post-menopause) must test negative for pregnancy at the time of screening based on a serum pregnancy test and must agree to use a reliable method of birth control during the study and for 3 months following completion of participation in the study
  • Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
  • Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
  • Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed

Who cannot join

  • Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Previous completion or withdrawal from this study or any other study investigating LY2951742 or other therapeutic antibodies that target calcitonin gene-related peptide (CGRP)
  • History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
  • History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
  • Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
  • Have a history or presence of any other medical illness that in the judgment of the Investigator, indicates a medical problem that would preclude study participation
Show all 10Show fewer
  • Women who are pregnant or nursing
  • Confirmed corrected QT (QTc) interval >470 milliseconds (msec) for women and >450 for men
  • Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
  • In the opinion of the Investigator, have no other issues that would interfere with compliance with the study requirements and completion of evaluations required for this study

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • FutureSearch Trials of Neurology and Sleep Lab

    Austin, Texas, 78731

  • Neurology Studies of Austin, A Division of DermResearch Inc.

    Austin, Texas, 78759

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Ryan Headache Center, St. John's Mercy Medical Group

    Chesterfield, Missouri, 63141

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • Radiant Research - Denver

    Denver, Colorado, 80239

  • PRI Encino

    Encino, California, 91316

  • Prarie Fields Medicine/Clinical Research Advantage

    Fremont, Nebraska, 68025

  • Neurological Physicians of Arizona / Clinical Research Advantage

    Gilbert, Arizona, 85234

  • PharmQuest

    Greensboro, North Carolina, 27408

  • James Meli DO Ltd (Clinical Research Advantage)

    Henderson, Nevada, 89014

  • Clinical Research Advantage

    Henderson, Nevada, 89052

  • Clinical Trial Network (CTN Texas)

    Houston, Texas, 77074

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California, 92647

  • Westside Family Medical Center, PC

    Kalamazoo, Michigan, 49009

  • Collaborative Neuroscience Network Inc.

    Long Beach, California, 90806

  • PRI Los Alamitos

    Los Alamitos, California, 90720

  • Florida Clinical Research Center LLC

    Maitland, Florida, 32751

  • Neurology & Headache Treatment Center

    McLean, Virginia, 22102

  • Accelovance, Inc

    Melbourne, Florida, 32935

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • PRI Newport Beach

    Newport Beach, California, 92660

  • Renstar Medical Research

    Ocala, Florida, 34471

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Broward Research Group

    Pembroke Pines, Florida, 33026

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • University of California, San Francisco (UCSF) Medical Center - Headache Center

    San Francisco, California, 94115

  • California Medical Clinic for Headache Inc

    Santa Monica, California, 90404

  • Mayo Foundation for Medical Education and Research - Mayo Clinic

    Scottsdale, Arizona, 85259

  • Clinvest, A Division of Banyan Group, Inc.

    Springfield, Missouri, 65807

  • Neurology Clinical Research Inc

    Sunrise, Florida, 33351

  • MedVadis Research

    Watertown, Massachusetts, 02472

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine

To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment.

Read the detailed description

The study is comprised of 4 trial periods:

  1. Screening and washout (5-45 days)
  2. Baseline for assessment of the type, frequency, and severity of headaches (28-38 days)
  3. Treatment (12 weeks)
  4. Follow-up (12 weeks)
Being tested
LY2951742, Placebo
Medical subject headings
Migraine Disorders

What participants receive

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

  • LY2951742Drug

  • PlaceboDrug

Study groups in NCT01625988
Study groupRoleWhat they receive
LY2951742ExperimentalLY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Receives: Drug: LY2951742
PlaceboPlacebo comparatorPlacebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Receives: Drug: Placebo

What is being measured

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

  1. Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase

    The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.

    Measured: Baseline, 12 weeks

Secondary outcomes (3)

  1. Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase

    Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.

    Measured: Baseline, 12 weeks

  2. Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase

    A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.

    Measured: Baseline, 12 weeks

  3. Percentage of Responders

    Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.

    Measured: Baseline, 4, 8, and 12 weeks

Timeline

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

  1. First posted22 Jun 2012 (estimated)
  2. Study start28 Jun 2012
  3. Primary completionJul 2013
  4. Study completion18 Sep 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625988
Sponsor's protocol ID
ART-01
Other IDs
ART-01
Status last verified
Apr 2014
First submitted
20 Jun 2012
Last updated
9 Jan 2020
Data monitoring committee
No

Publications

  • Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

    PubMed 32576229

  • Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q, Skljarevski V, Aurora SK. Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):939-944. doi: 10.1136/jnnp-2018-320242. Epub 2019 Apr 19.

    PubMed 31004075

  • Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014 Sep;13(9):885-92. doi: 10.1016/S1474-4422(14)70128-0. Epub 2014 Aug 10.

    PubMed 25127173

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2951742 in people with Migraine Headache, run by Eli Lilly and Company at 37 sites in United States.

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 5 inclusion and 10 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Jan 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?

Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase (time frame: Baseline, 12 weeks). 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 NCT01625988, which also lists 3 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 9 Jan 2020.

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