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

Primary Purpose

Trigeminal Neuralgia, Glossopharyngeal Neuralgia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Galcanezumab

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Galcanezumab

Arm 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.

Outcomes

Primary Outcome Measures

Change in pain score

Pt. reported 0-10 analog pain scale

Change in use of rescue and other anti-pain medications

Pt. reported, any use of anti-pain medication

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.

Secondary Outcome Measures

Change in circadian rhythm impairment

Based on data from Wearable Sleep Monitor

Change in subject's pain/inflammation markers

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

Genomic DNA testing

Full Information

NCT ID

NCT04158752

First Posted

October 30, 2019

Last Updated

March 29, 2023

Sponsor

Duke University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04158752

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 24, 2020 (Actual)

Primary Completion Date

January 4, 2023 (Actual)

Study Completion Date

January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia, Glossopharyngeal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label Galcanezumab

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Galcanezumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in pain score

Description

Pt. reported 0-10 analog pain scale

Time Frame

Daily, from Baseline through Day 180

Title

Change in use of rescue and other anti-pain medications

Description

Pt. reported, any use of anti-pain medication

Time Frame

Daily, from Baseline through Day 180

Title

Number of adverse events, by type and severity

Description

Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review.

Time Frame

Collected through Day 180

Secondary Outcome Measure Information:

Title

Change in circadian rhythm impairment

Description

Based on data from Wearable Sleep Monitor

Time Frame

Daily, from Baseline through Day 180

Title

Change in subject's pain/inflammation markers

Description

Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum

Time Frame

Day 0, Day 45, Day 75 and Day 105

Title

Presence or absence of DNA polymorphisms that predispose treated patients to accentuated responses of either lack of response or particularly potent response

Description

Genomic DNA testing

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sweta Sengupta, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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