Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia

Recruiting in Durham (>99 mi)

Overseen By Vera George

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test a migraine medication on people with nerve pain to see if it reduces their pain and need for other painkillers. The study will also check if the medication is safe for these people.

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 known about the safety of Galcanezumab (Emgality) in humans?

Galcanezumab has been evaluated for safety in pregnancy and lactation, showing it has a safety profile that has been assessed in these conditions. ^{1 2 3 4 5}

How is the drug Galcanezumab different from other treatments?

Galcanezumab is unique because it specifically targets and blocks a protein called calcitonin gene-related peptide (CGRP), which is involved in causing migraines. This mechanism of action is different from traditional migraine treatments that often focus on relieving symptoms rather than preventing them. ^{6 7 8 9 10}

Research Team

Sweta Sengupta, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

Interventions

• Galcanezumab

Participant Groups

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

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. [2021]

3. England 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting Ewing sarcoma with activated and GD2-specific chimeric antigen receptor-engineered human NK cells induces upregulation of immune-inhibitory HLA-G. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: clinical implications of the effect of covariates. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Trastuzumab-emtansine induced pleural and pericardial effusions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Structural Characterization of Cross-Linked Species in Trastuzumab Emtansine (Kadcyla). [2019]

10. United States 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. [2022]