Galcanezumab for Nerve Pain

Overseen By Vera George

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Allergy to monoclonal antibodies, Pregnancy, 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: 3

Duration: 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Galcanezumab to reduce pain and the need for pain medications in individuals with certain nerve pain conditions. The focus is on those with trigeminal or glossopharyngeal nerve pain, often associated with painful small fiber neuropathy or fibromyalgia. The trial also aims to confirm the safety of Galcanezumab, which previous migraine studies have found safe. Suitable participants typically have a diagnosis of nerve pain in the face or throat area and confirmed painful small fiber neuropathy. As a Phase 4 trial, Galcanezumab is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial aims to reduce the use of rescue and other anti-pain medications, but it does not specify if you must stop taking your current medications. It's best to discuss this with the trial coordinators.

What is the safety track record for Galcanezumab?

Research has shown that galcanezumab, the treatment in this trial, is generally well-tolerated. In earlier studies with migraine patients, the most common side effect was reactions at the injection site, typical for injectable medications and usually mild.

No serious safety issues were reported, except for rare cases of allergic reactions to the drug or its ingredients. This indicates that, for most people, galcanezumab does not cause severe side effects.

This medication has already undergone thorough testing and received approval for treating migraines, reflecting a good safety record as many patients have used it.

Overall, evidence suggests that galcanezumab is safe for most people, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Galcanezumab is unique because it targets a protein called calcitonin gene-related peptide (CGRP), which plays a role in inflammation and pain, particularly in conditions like small fiber neuropathy and fibromyalgia. Unlike traditional treatments that mainly focus on symptom relief through painkillers or antidepressants, Galcanezumab works by blocking CGRP, potentially addressing the underlying mechanism of pain and inflammation. Researchers are excited about this treatment because it offers a novel approach that might provide more effective and faster relief for patients who don't respond well to current therapies.

What is the effectiveness track record for Galcanezumab in treating nerve pain?

Research has shown that galcanezumab, the treatment under study in this trial, can reduce the frequency and severity of migraines and cluster headaches. One study found that participants taking galcanezumab experienced fewer headaches each week compared to those taking a placebo, which contains no active medicine. Other studies have found that it also alleviated migraine symptoms and improved sleep quality. Although galcanezumab is primarily used for migraines, it may also benefit conditions like small fiber neuropathy and fibromyalgia, which involve nerve pain, due to its effects on pain and inflammation. Given its success with similar conditions, there is reason to believe it could alleviate pain in the trigeminal or glossopharyngeal nerves. ^{6 7 8 9 10}

Who Is on the Research Team?

Sweta Sengupta, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Assigned diagnosis of non-neuralgic trigeminal nerve pain G50.1, with all its permutations listed in the ICD10 explicitly allowed

Alternatively, glossopharyngeal nerve pain with a G52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve

Diagnosed with a painful small fiber neuropathy based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count

Exclusion Criteria

History of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody

Female patients of child-bearing age who are or want to become pregnant will be excluded

In case such a patient intends to participate, then she has to commit to a pregnancy prevention regimen that is based on hormonal contraceptive or intra-uterine device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Galcanezumab injections on Day 30, Day 60, and Day 90

90 days

3 visits (in-person for injections), self-administration at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Galcanezumab

How Is the Trial Designed?

Group I: Open Label Galcanezumab Experimental Treatment 1 Intervention

Participants will receive their 1st injectable dose during the Day 30 visit. Participants will then inject themselves at home on Day 60 and again on Day 90.

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?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

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

In a study involving 369 patients with rheumatoid arthritis, switching from adalimumab to sarilumab monotherapy led to significant improvements in disease activity, with 47.1% of switch patients showing meaningful changes in their Disease Activity Score by week 12 of the open-label extension.

The safety profile of sarilumab remained consistent with previous reports, showing no unexpected safety issues, and patients who continued on sarilumab experienced sustained benefits in disease management over the 48-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension. Burmester, GR., Strand, V., Rubbert-Roth, A., et al.[2020]

A review of 94 safety reports on erenumab, galcanezumab, and fremanezumab found no significant increase in spontaneous abortion or major birth defects, suggesting these medications may be relatively safe during pregnancy and lactation.

Despite the lack of strong evidence for maternal toxicities or adverse outcomes, the limited number of reports and absence of long-term safety data indicate that ongoing monitoring of these drugs in pregnant and lactating women is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. Noseda, R., Bedussi, F., Gobbi, C., et al.[2021]

In the EMILIA phase 3 study, trastuzumab emtansine (T-DM1) significantly delayed the time to symptom worsening in patients with HER2-positive breast cancer, with a duration of 7.1 months compared to 4.6 months for capecitabine and lapatinib.

Patients treated with T-DM1 experienced a lower incidence of diarrhea symptoms during treatment, maintaining levels near baseline, while those on capecitabine and lapatinib saw a 1.5- to 2-fold increase, indicating better tolerability for T-DM1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer. Welslau, M., Diéras, V., Sohn, JH., et al.[2022]

Citations

1. emgality.lilly.com emgality.lilly.com/hcp/migraine/conquer-study-efficacy

CONQUER Data | Emgality® (galcanezumab-gnlm) - Eli Lilly Patients taking Emgality reported improvement in the burden of migraine in between attacks, as assessed by the MIBS-4.

2. 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 ...

3. emgality.lilly.com emgality.lilly.com/hcp/cluster/efficacy

Study Design | Episodic Cluster Headache - Emgality - Eli Lilly Patients on Emgality 300 mg (N=49) experienced a mean reduction in weekly headache attack frequency of -8.7b vs -5.2 for placebo (N=57).

4. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01690-2

Long-term effectiveness and tolerability of galcanezumab in ... Galcanezumab has shown efficacy and effectiveness in the treatment of episodic and chronic migraine (CM), however, the population represented in ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1411238/full

Effectiveness of galcanezumab on sleep quality, migraine ... By the 3rd month of galcanezumab injections, significant improvement was observed in the sleep disturbances domain in the overall study ...

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

Safety Data | Emgality® (galcanezumab-gnlm) - Eli Lilly The most common adverse reactions (incidence >2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions. References.

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

CONQUER Study Safety Data | Emgality® (galcanezumab-gnlm) IMPORTANT SAFETY INFORMATION. Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

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

EMGALITY (galcanezumab-gnlm) - accessdata.fda.gov The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of EMGALITY, representing 1487 patient- ...

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

Emgality, INN-galcanezumab - EMA Pregnancy There are limited data from the use of galcanezumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...

10. ehs.lilly.com ehs.lilly.com/Emgality.pdf

Emgality™ (Galcanezumab Injection) - SDS US - Eli Lilly Not listed. Animal studies did not report any adverse effects on reproductive tissues, fertility, or embryo/fetal development. (subcutaneous) ( ...