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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02163993
Other study ID # 15414
Secondary ID I5Q-MC-CGAB
Status Completed
Phase Phase 2
First received
Last updated
Start date July 7, 2014
Est. completion date February 12, 2018

Study information

Verified date June 2017
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.


Recruitment information / eligibility

Status Completed
Enrollment 414
Est. completion date February 12, 2018
Est. primary completion date August 19, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Participants with a history of migraine of at least 1 year prior to enrollment.

- Migraine onset prior to age 50.

Exclusion Criteria:

- Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.

- Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).

- History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.

- Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.

- Failure to respond to more than two adequately dosed effective migraine prevention treatments.

- Evidence of significant active psychiatric disease, in the opinion of the investigator.

- Women who are pregnant or nursing.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Galcanezumab
Administered SQ
Placebo
Administered SQ

Locations

Country Name City State
United States Albuquerque Clinical Trials Albuquerque New Mexico
United States Michigan Head, Pain and Neurological Institute Ann Arbor Michigan
United States DermResearch Austin Texas
United States FutureSearch Trials Austin Texas
United States PharmaSite Research Inc Baltimore Maryland
United States Northwest Clinical Research Center Bellevue Washington
United States Boston Clinical Trials Inc Boston Massachusetts
United States Alpine Clinical Research Center Boulder Colorado
United States Avail Clinical Research LLC DeLand Florida
United States Otri-Med Corporation Edgewood Kentucky
United States Pharmacology Research Institute, Long Beach Encino California
United States Clinical Research Advantage Gilbert Arizona
United States PharmQuest Greensboro North Carolina
United States Westside Family Medical Center Kalamazoo Michigan
United States Collaborative Neuroscience Network - CNS Long Beach California
United States Pharmacology Research Institute, Long Beach Los Alamitos California
United States Florida Clinical Research Center LLC Maitland Florida
United States CNS Health Care Memphis Tennessee
United States Dean Foundation for Health Research and Education Middleton Wisconsin
United States Coastal Carolina Research Center, Inc. Mount Pleasant South Carolina
United States Pharmacology Research Institute, Long Beach Newport Beach California
United States Renstar Medical Research Ocala Florida
United States Psychiatric Inst of Florida-Clinical Neuroscience Solutions Orlando Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States 21st Century Neurology Phoenix Arizona
United States Arizona Research Center Phoenix Arizona
United States Island Neuro Associates,PC Plainview New York
United States Summit Research Network Inc Portland Oregon
United States Desert Valley Research Rancho Mirage California
United States Rochester Clinical Research, Inc. Rochester New York
United States Mercy Health Research Saint Louis Missouri
United States Artemis Institute for Clinical Research San Diego California
United States Medical Center for Clinical Research San Diego California
United States San Francisco Clinical Research Center San Francisco California
United States California Medical Clinic for Headache Santa Monica California
United States North Seattle Womens Group Seattle Washington
United States ClinVest Springfield Missouri
United States New England Institute for Clinical Research Stamford Connecticut
United States Premiere Research Institute at Palm Beach Neurology West Palm Beach Florida
United States PMG Research of Winston-Salem, LLC Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (ICHD)-3 beta. 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-3 beta 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. Baseline, 12 Weeks
Secondary Mean Change From Baseline in 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 was adapted from the standard IHS ICHD-3 beta definition. 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-3 beta 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 Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction. Baseline, 12 Weeks
Secondary Percentage of Participants With =50% Reduction in 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 (ICHD)-3 beta definition. 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-3 beta 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. Week 12
Secondary Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache 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 was adapted from the standard IHS ICHD-3 beta definition. 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-3 beta 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 Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction. Baseline, 12 Weeks
Secondary Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction. Baseline, 12 Weeks
Secondary Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline. Baseline, 12 Weeks
Secondary Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline. Baseline, 12 Weeks
Secondary Serum Concentration of Galcanezumab Blood serum concentrations of galcanezumab. 12 Weeks
Secondary Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993). 12 Weeks
Secondary Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer >=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement. Baseline through 12 Weeks
Secondary Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Baseline through Week 12
Secondary 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-3 beta definition. It is defined as headache with or without aura, of =30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta 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 treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction. Baseline, 12 Weeks
Secondary Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase Number of calendar days on which headache lasts =4 hrs it includes migraines, PM & non-migraines. MH is headache with or without aura, of =30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta 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 &/or vomiting, or photophobia & phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction. Baseline, 12 Weeks
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