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

Sponsors

Lead Sponsor: Duke University

Collaborator: Eli Lilly and Company

Source 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.

Overall Status Recruiting
Start Date 2020-07-24
Completion Date 2021-12-01
Primary Completion Date 2021-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in pain score Daily, from Baseline through Day 180
Change in use of rescue and other anti-pain medications Daily, from Baseline through Day 180
Number of adverse events, by type and severity Collected through Day 180
Secondary Outcome
Measure Time Frame
Change in circadian rhythm impairment Daily, from Baseline through Day 180
Change in subject's pain/inflammation markers 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 Day 0
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Galcanezumab

Description: Injection of study drug at 3 timepoints (day 30, day 60, day 90)

Arm Group Label: Open Label Galcanezumab

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Wolfgang Liedtke, MD, PhD Principal Investigator Duke University
Overall Contact

Last Name: Kelsey Ling

Phone: 919 684 2713

Email: [email protected]

Location
Facility: Status: Contact: Duke University Kelsey Ling 919-684-2713 [email protected]
Location Countries

United States

Verification Date

2020-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Open Label Galcanezumab

Type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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