Anti-CGRP for Inflamation 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

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.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia; Glossopharyngeal Neuralgia
• Intervention / Treatment: Drug: Galcanezumab

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label 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.	Drug: Galcanezumab; Injection of study drug at 3 timepoints (day 30, day 60, day 90)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Sweta Sengupta, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Fibromyalgia; Trigeminal Neuralgia; Small Fiber Neuropathy; Glossopharyngeal Nerve Diseases
• Other Study ID Numbers: Pro00103776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No