CLINICAL TRIAL

Galcanezumab for Migraine

Recruiting · 18+ · All Sexes · Gilbert, AZ

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

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About the trial for Migraine

Eligible Conditions
Migraine · Episodic Migraine · Migraine Disorders

Treatment Groups

This trial involves 2 different treatments. Galcanezumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Galcanezumab
DRUG
Placebo
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG
Rimegepant
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galcanezumab
FDA approved
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Month 1 through Month 3
Screening: ~3 weeks
Treatment: Varies
Reporting: Month 1 through Month 3
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Month 1 through Month 3.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Galcanezumab will improve 1 primary outcome and 10 secondary outcomes in patients with Migraine. Measurement will happen over the course of Baseline, 3 Months.

Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score
BASELINE, 3 MONTHS
Change from baseline in MIDAS total score
BASELINE, 3 MONTHS
Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
BASELINE, 3 MONTHS
Change from baseline in RF-P Domain Score of MSQ v2.1
BASELINE, 3 MONTHS
Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
BASELINE, 3 MONTHS
Change from baseline in EF domain score of MSQ v2.1
BASELINE, 3 MONTHS
Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score
BASELINE, 3 MONTHS
Change from baseline in MSQ v2.1 total score
BASELINE, 3 MONTHS
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
BASELINE, 3 MONTHS
Mean change from baseline in the number of monthly migraine headache days
BASELINE, 3 MONTHS
Mean Change from Baseline in the Role Function-Restrictive (RF-R) Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
BASELINE, 3 MONTHS
Mean Change from Baseline in the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
BASELINE, 3 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the average age someone gets episodic migraine?

In the United Kingdom, one out of 50 will be diagnosed with episodic migraine by 10 years of age, and one out of 10 will get it before the age of 60.

Anonymous Patient Answer

What causes episodic migraine?

Most women do not report any other triggers; only some women report headaches that are associated with other triggers, such as fatigue, dizziness, neck pain, or stressful situations.

Anonymous Patient Answer

What is episodic migraine?

Migraine attacks happen about 20 times a year for 10% of the population, with a 1/4 prevalence associated with headache severity. Although women are most affected, headache is a disease that affects all age groups due to socioeconomic and interpersonal differences.

Anonymous Patient Answer

Can episodic migraine be cured?

A subset of patients with migraine may be able to experience significant improvement in the frequency and the pain accompanying the attacks with the administration of triptans.

Anonymous Patient Answer

How many people get episodic migraine a year in the United States?

In this large US population-based study, episodic migraine affects 11.2% of the individuals. Nearly half suffer from moderate to severe disability; however, only 2% were admitted to rehabilitation services.

Anonymous Patient Answer

What are the signs of episodic migraine?

A patient who has presented to a physician within one or two days with a headache of new onset, with no previous history is most likely to have episodic migraine. Migrainous episodes can usually be distinguished from other headache syndromes, and treatment should focus on treatment of episodic migraines.

Anonymous Patient Answer

What are common treatments for episodic migraine?

There are no definitive treatments for episodic migraine. Appropriate evaluation of each migraine episode should be made after treatment planning. Treatment will typically involve medications, therapy, or a combination.

Anonymous Patient Answer

Is galcanezumab safe for people?

We conclude that galcanezumab is well tolerated in people. When used as intended in this observational study, galcanezumab was associated with little or no significant loss of efficacy with repeated administrations and no serious adverse events occurred. summary: Data from a recent study examines the safety of galcanezumab, which has shown some promise in treating the symptoms of multiple sclerosis in a small clinical trial, in people with episodic migraine. We find the drug was well tolerated.

Anonymous Patient Answer

How serious can episodic migraine be?

Data from a recent study suggest that a significant percentage of patients presenting with recurrent episodic migraine could have additional episodic migraine attacks that are actually severe.

Anonymous Patient Answer

What is the latest research for episodic migraine?

Although the evidence base is sparse, and the studies published often do not have sufficient methodology, the evidence on this review does suggest that there is substantial improvement from placebo in terms of reduction vs non-migraine sufferers in pain and treatment response. There is no evidence of worsening over time in both acute and chronic episodic migraine with respect to pain intensity, disability and quality of life. One review of one of the medications (palmitoylethanolamide (PEA) suggests its efficacy may be transient and of limited duration, and that the evidence base is less robust. There is no evidence in episodic migraine that it results in significant improvements in sleep, alertness or cognitive function.

Anonymous Patient Answer

Does episodic migraine run in families?

Familial clustering was observed in this population. Previous reports of high prevalence and familial clustering of episodic migraine have yielded support for a genetic basis. Results from a recent clinical trial illustrates the potential role of genetic factors, independent of familial clustering, in the etiopathogenesis and clinical expression of episodic migraine.

Anonymous Patient Answer

Has galcanezumab proven to be more effective than a placebo?

Galcanezumab was found to be more effective than the placebo in reducing migraine-related disability and alleviating migraine-associated fear of pain and anxiety. Furthermore, Galcanezumab shows promise for providing superior outcome when compared to sumatriptan and naratriptan in patients with episodic migraine.

Anonymous Patient Answer
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