Overview

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

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
Eli Lilly and Company
Criteria
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.