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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158752
• Other study ID #: Pro00103776
• Status: Completed
• Phase: Phase 4
• Start date: July 24, 2020
• Est. completion date: January 4, 2023

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Glossopharyngeal Neuralgia
• Neuralgia
• Small Fiber Neuropathy
• Trigeminal Neuralgia

Intervention

Drug:
• Galcanezumab
Injection of study drug at 3 timepoints (day 30, day 60, day 90)

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score	Pt. reported 0-10 analog pain scale	Daily, from Baseline through Day 180
Primary	Change in use of rescue and other anti-pain medications	Pt. reported, any use of anti-pain medication	Daily, from Baseline through Day 180
Primary	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	Change in circadian rhythm impairment	Based on data from Wearable Sleep Monitor	Daily, from Baseline through Day 180
Secondary	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
Secondary	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