NCT04158752

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trigeminal Neuralgia
• Glossopharyngeal Neuralgia

Interventions

Type	Name	Description
DRUG	Galcanezumab	Injection of study drug at 3 timepoints (day 30, day 60, day 90)

Timeline

• Start date: 2020-07-24
• Primary completion: 2023-01-04
• Completion: 2023-01-04
• First posted: 2019-11-12
• Last updated: 2026-02-02
• Results posted: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study