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

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ClinicalTrials.gov Identifier: NCT04158752
Recruitment Status : Suspended (Recruitment is temporarily suspended, related to COVID-19.)
First Posted : November 12, 2019
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
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.

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

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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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021


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)




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



Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Eli Lilly and Company
Investigators
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Principal Investigator: Wolfgang Liedtke, MD, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04158752    
Other Study ID Numbers: Pro00103776
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases