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

Phase 4

Completed

• Conditions: Trigeminal Neuralgia; Glossopharyngeal Neuralgia
• Interventions: Drug: Galcanezumab

• Registration Number: NCT04158752
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-12
• Study Start: 2020-07-24
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Galcanezumab	Galcanezumab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States