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

NCT04158752 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00103776
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia; Glossopharyngeal Neuralgia

Outcome Measures

Primary Outcomes (3)

• Change in Pain Score

  Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints.

  Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days

• Number of Participants With a Change in Use of Anti-pain Medication

  Patient reported; any use of anti-pain medication.

  Baseline through Day 135

• Total Number of Adverse Events by Severity

  Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review. Adverse events can be classified into five severity grades (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death).

  Collected through Day 180

Secondary Outcomes (2)

• Change in Level of TNF-alpha as a Marker of Pain or Inflammation

  Baseline, Day 180

• Change in Level of IL-6 as a Marker of Pain or Inflammation

  Baseline, Day 180

Other Outcomes (2)

• Change in Circadian Rhythm Impairment

  Daily, from Baseline through Day 180

• Presence or Absence of DNA Polymorphisms That Predispose Treated Patients to Accentuated Responses of Either Lack of Response or Particularly Potent Response

  Day 0

Study Arms (1)

Open Label Galcanezumab

EXPERIMENTAL

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

Interventions

Galcanezumab DRUG

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

Open Label Galcanezumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Glossopharyngeal Nerve Diseases

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Results Point of Contact

• Title: Sweta Sengupta, MD
• Organization: Duke University

sweta.sengupta@duke.edu

919-668-2879

Study Officials

• Sweta Sengupta, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 12, 2019
• Study Start: July 24, 2020
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)