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

• ClinicalTrials.gov Identifier: NCT04158752
• Recruitment Status: Recruiting
• First Posted: November 12, 2019
• Last Update Posted: August 12, 2020
• Sponsor: Duke University
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trigeminal Neuralgia; Glossopharyngeal Neuralgia	Drug: Galcanezumab	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia
• Actual Study Start Date: July 24, 2020
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Change in pain score [ Time Frame: Daily, from Baseline through Day 180 ]
   Pt. reported 0-10 analog pain scale
2. Change in use of rescue and other anti-pain medications [ Time Frame: Daily, from Baseline through Day 180 ]
   Pt. reported, any use of anti-pain medication
3. Number of adverse events, by type and severity [ Time Frame: 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 :

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Kelsey Ling; 919 684 2713; kelsey.ling@duke.edu

Locations

United States, North Carolina

Duke University; Recruiting

Durham, North Carolina, United States, 27705

Contact: Kelsey Ling 919-684-2713 kelsey.ling@duke.edu

Sponsors and Collaborators

Duke University

Eli Lilly and Company

Investigators

• Principal Investigator: Wolfgang Liedtke, MD, PhD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04158752
• Other Study ID Numbers: Pro00103776
• First Posted: November 12, 2019
• Last Update Posted: August 12, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Fibromyalgia; Trigeminal Neuralgia; Neuralgia; Small Fiber Neuropathy; Glossopharyngeal Nerve Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Pain; Neurologic Manifestations; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases