Emgality for Migraine Prevention

Overseen By Rami Burstein

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Antidepressants, Anticonvulsants, Beta-blockers

Disqualifiers: Cardiac disease, Cerebrovascular disease, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the migraine prevention drug Emgality works in the body, specifically whether it acts inside or outside the brain. The focus is on understanding how this medication helps prevent migraines. Suitable candidates for this trial have a migraine diagnosis according to standard criteria and experience between 10 to 25 headache days a month, with at least 8 being migraines. Participants should not use other migraine prevention treatments and must maintain a stable medication routine. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking your current migraine preventative medications, as the trial excludes those on such therapies. However, you can continue other medications as long as you don't change their type, dosage, or frequency during the study.

What is the safety track record for Galcanezumab?

Research shows that galcanezumab, also known as Emgality, is generally safe for preventing migraines. Studies have found that most people tolerate it well. The most common side effects are mild and occur at the injection site, such as redness or swelling.

A large clinical trial involving over 2,500 patients confirmed that serious side effects are rare. The FDA has already approved Emgality for preventing migraines in adults, indicating it has passed several safety checks. Overall, evidence suggests that galcanezumab is a safe option for migraine prevention. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about galcanezumab (Emgality) for migraine prevention because it targets a specific protein involved in migraines called calcitonin gene-related peptide (CGRP). Unlike many traditional migraine treatments that focus on alleviating symptoms after they begin, galcanezumab works by preventing the onset of migraines. This injectable treatment offers a new approach by potentially reducing the frequency of migraines with a monthly dosage, which could be more convenient compared to daily oral medications. Additionally, its targeted mechanism might result in fewer side effects, making it a promising option for those who haven't found relief with existing treatments.

What is the effectiveness track record for Emgality in migraine prevention?

Research has shown that galcanezumab, the treatment under study in this trial, helps prevent migraines. In one study, about 62% of patients experienced a reduction of half or more in their monthly headache days with this treatment. Another study found that the drug was effective even for those who did not find relief from 3-4 other treatments. Additionally, from month 3 to month 12 of using the drug, participants had about 10 fewer headache days each month on average. These results demonstrate that galcanezumab can significantly reduce the frequency and impact of migraines. ^{6 7 8 9 10}

Who Is on the Research Team?

Rami Burstein

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a history of migraines, experiencing 10-25 headache days per month. Participants must not be on migraine prevention therapy or have other significant pain issues, severe cardiac disease, substance abuse history, or use marijuana. Pregnant women and those not using birth control are excluded.

Inclusion Criteria

I have 10-25 headache days a month, with at least 8 being long-lasting migraines.

I have been diagnosed with migraine, following official guidelines.

My migraines started when I was 50 or younger.

Exclusion Criteria

My blood pressure is not higher than 160/100 mm Hg.

I have had botulinum toxin or anti-CGRP-mAb injections in the past 6 months.

I have used marijuana or CBD oil in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Pre-Treatment Assessment

Participants undergo medical and headache history review, physical examination, and e-diary education

1 month

3 visits (in-person)

Treatment

Participants receive galcanezumab treatment and undergo fMRI sessions

3 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in migraine triggers and brain functioning

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Galcanezumab

Trial Overview The study tests the effects of Emgality (Galcanezumab), a CGRP-targeted monoclonal antibody for preventing migraines. It aims to determine whether its main effect is inside or outside the brain and identify specific action sites.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1 and 2 month later) on brain functioning.

Galcanezumab is already approved in European Union, United States for the following indications:

Approved in European Union as Emgality for:

• Prophylaxis of migraine in adults who have at least four migraine days per month

Approved in United States as Emgality for:

• Preventive treatment of migraine in adults
• Treatment of episodic cluster headache

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Galcanezumab is a humanized monoclonal antibody that targets the calcitonin gene-related peptide (CGRP), which plays a key role in migraine development, and was approved by the FDA in September 2018 for the preventive treatment of migraines in adults.

The approval was based on its efficacy in reducing the frequency of migraine days for adults experiencing at least 4 migraines per month, and it is also being studied for the prevention of cluster headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Galcanezumab: First Global Approval. Lamb, YN.[2019]

Galcanezumab, a monoclonal antibody, demonstrated significant efficacy in reducing monthly migraine headache days over a 12-month period, with patients experiencing an average reduction of 8.0 to 9.0 days from a baseline of 19.4 days.

The treatment was found to be safe and well-tolerated, with a low discontinuation rate of 5% due to adverse events, indicating high adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Pozo-Rosich, P., Detke, HC., Wang, S., et al.[2022]

Galcanezumab (GMB) treatment significantly reduced annual indirect costs for patients with episodic migraine (EM), leading to improved productivity at work, household tasks, and leisure activities, as shown in a study of 805 EM patients.

While GMB also provided cost savings for chronic migraine (CM) patients, these were not statistically significant, indicating that the most pronounced benefits of GMB are seen in those with episodic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States. Varnado, OJ., Ye, W., Mi, X., et al.[2023]

Galcanezumab, a monoclonal antibody targeting the CGRP ligand, has shown significant efficacy in reducing the frequency of migraine attacks in both episodic and chronic migraine patients, as demonstrated in phase 3 studies involving multiple months of treatment.

Patients receiving galcanezumab reported improved quality of life and functioning, with a high percentage achieving substantial reductions in migraine days, and the treatment was well tolerated over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review. Martin, V., Samaan, KH., Aurora, S., et al.[2021]

In a real-world study of 52 patients in Japan, galcanezumab significantly reduced monthly migraine days by an average of 5.9 days after three doses, demonstrating its efficacy in treating migraines.

The treatment also improved associated symptoms like photophobia and nausea in over half of the patients, although more than 60% reported premonitory symptoms without subsequent headaches, indicating a need for further monitoring of these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. Takizawa, T., Ohtani, S., Watanabe, N., et al.[2023]

In a study involving 1113 patients with chronic migraine, treatment with galcanezumab significantly improved quality of life and reduced disability compared to placebo, with notable improvements in functioning as measured by the Migraine-Specific Quality-of-Life Questionnaire.

At the 3-month mark, patients receiving galcanezumab (both 120 mg and 240 mg doses) showed greater reductions in migraine-related disability compared to placebo, indicating that galcanezumab is an effective treatment option for enhancing patient functioning in chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN). Ford, J., Tassorelli, C., Leroux, E., et al.[2021]

In a post hoc analysis of patients with episodic (N=879) and chronic (N=555) migraine who did not show significant improvement after 1 month of galcanezumab treatment, a notable percentage still achieved 'good' responses with continued treatment, especially those with 'modest' early improvement (62% for episodic and 38% for chronic).

Even patients with minimal or no early improvement had some chance of achieving a 'good' response with ongoing treatment, although the likelihood was lower, indicating that continued treatment may still be beneficial for certain patients despite initial lack of response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Nichols, R., Doty, E., Sacco, S., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41017292/

Results from the TRIUMPH study Findings from this study showed that patients receiving galcanezumab had greater treatment effectiveness after 3 months than those receiving ...

2. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.15064?af=R

Effectiveness and tolerability of galcanezumab for migraine ... Effectiveness was defined as ≥50% reduction in monthly headache days (MHD), and excellent response as ≥75% reduction at 6 months. Tolerability ...

3. emgality.lilly.com emgality.lilly.com/hcp/migraine/efficacy-episodic

Episodic Migraine Efficacy | Emgality® (galcanezumab-gnlm) Mean percentage of patients who experienced a ≥50% reduction in MHDs with Emgality 120 mg was 62%c vs 39% with placebo respectively; Mean percentage of patients ...

4. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-021-01322-7

Efficacy of galcanezumab in patients with migraine and history ... Galcanezumab was effective in a difficult-to-treat population of patients with CM or EM who had failed 3–4 prior preventive medication categories.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38329615/

Long-Term Effectiveness of Galcanezumab in the ... From month 3 to month 12, MMDs decreased on average by 10 days. Headache impact and disability, as well as migraine-associated health resource ...

6. emgality.lilly.com emgality.lilly.com/hcp/safety

Safety Data | Emgality® (galcanezumab-gnlm) - Eli Lilly The safety of Emgality was evaluated in a large clinical trial program in migraine prevention ; Adverse Reaction, Emgality 120 mg (N=705), Placebo (N=1451) ...

7. emgality.lilly.com emgality.lilly.com/hcp/conquer-safety

CONQUER Study Safety Data | Emgality® (galcanezumab-gnlm) Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32319039/

Efficacy and Safety of Galcanezumab for the Preventive ... Galcanezumab was well tolerated, with the most common adverse events being injection site reactions. The results from the clinical trials of galcanezumab ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf

EMGALITY (galcanezumab-gnlm) - accessdata.fda.gov EMGALITY is indicated for the preventive treatment of migraine in adults. ... The safety of EMGALITY has been evaluated in 2586 patients ...

10. ema.europa.eu ema.europa.eu/en/documents/product-information/emgality-epar-product-information_en.pdf

Emgality, INN-galcanezumab - EMA No safety data are available in these patients. ... migraine efficacy studies, i.e. galcanezumab treatment led to a mean reduction in monthly migraine.