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

Study Overview
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Brief Summary
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The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. The primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. Another goal is to monitor and confirm the safety profile established in the migraine population, during previous Phase 3 trials.

Official Title
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Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia

Conditions
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Trigeminal Neuralgia, Glossopharyngeal Neuralgia

Intervention / Treatment
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* Drug: Galcanezumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years old. The patient must have an assigned diagnosis of non-neuralgic trigeminal nerve pain G50.1, with all its permutations listed in the ICD10 explicitly allowed. Co-morbid trigeminal neuralgia G50.0 and G43. … related headache codes are allowed. As an alternative to trigeminal nerve pain G50.1, glossopharyngeal nerve pain will be another inclusion criterion, with a G52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve. In addition, patients have to be diagnosed with a painful small fiber neuropathy. This diagnosis is based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count. The required ICD10 diagnostic codes are G63.3, G60.8, G62.8. Co-morbidity with a fibromyalgia-related disorder will be allowed, typically summarized under a diagnosis code of M79.7. Exclusion Criteria: Patients that have a history of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody will be excluded. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Galcanezumab<br>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. | Drug: Galcanezumab<br>* Injection of study drug at 3 timepoints (day 30, day 60, day 90)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score | Pt. reported 0-10 analog pain scale | Daily, from Baseline through Day 180 | 
| Change in use of rescue and other anti-pain medications | Pt. reported, any use of anti-pain medication | Daily, from Baseline through Day 180 | 
| Number of adverse events, by type and severity | Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review. | Collected through Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in circadian rhythm impairment | Based on data from Wearable Sleep Monitor | Daily, from Baseline through Day 180 | 
| Change in subject's pain/inflammation markers | Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum | Day 0, Day 45, Day 75 and Day 105 | 
| Presence or absence of DNA polymorphisms that predispose treated patients to accentuated responses of either lack of response or particularly potent response | Genomic DNA testing | Day 0 |