Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
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ClinicalTrials.gov Identifier: NCT04158752 |
Recruitment Status :
Recruiting
First Posted : November 12, 2019
Last Update Posted : February 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Trigeminal Neuralgia Glossopharyngeal Neuralgia | Drug: Galcanezumab | Phase 4 |
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 : | February 2023 |
Estimated Study Completion Date : | February 2023 |

Arm | Intervention/treatment |
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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.
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Drug: Galcanezumab
Injection of study drug at 3 timepoints (day 30, day 60, day 90) |
- Change in pain score [ Time Frame: Daily, from Baseline through Day 180 ]Pt. reported 0-10 analog pain scale
- 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
- 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.
- Change in circadian rhythm impairment [ Time Frame: Daily, from Baseline through Day 180 ]Based on data from Wearable Sleep Monitor
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158752
Contact: Vera George | 919 668-1538 | vera.george@duke.edu |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Vera George 919-668-1538 vera.george@duke.edu |
Principal Investigator: | Sweta Sengupta, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04158752 |
Other Study ID Numbers: |
Pro00103776 |
First Posted: | November 12, 2019 Key Record Dates |
Last Update Posted: | February 24, 2022 |
Last Verified: | August 2021 |
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 |
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 |