NCT04158752|CompletedPhase 4ResultsDMCFDA Drug
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Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia
Sponsor study identifier
interventional
26
1 country
1
Study Start
July 24, 2020
Actual (reported)Primary Completion
January 4, 2023
Actual (reported)Study Completion
January 4, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 4, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2019
Actual (reported)November 12, 2019
Actual (reported)July 24, 2020
Actual (reported)January 4, 2023
Actual (reported)January 4, 2023
Actual (reported)February 2, 2026
Actual (reported)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
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
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
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.
Injection of study drug at 3 timepoints (day 30, day 60, day 90)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke University
Durham, North Carolina, 27705, United States
Sweta Sengupta, MD
Duke University
26 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2019
First Posted
November 12, 2019
Study Start
July 24, 2020
Actual (reported)Primary Completion
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Contact the study team to confirm eligibility.
January 4, 2023
Actual (reported)Study Completion
January 4, 2023
Actual (reported)Last Updated
February 2, 2026
Results First Posted
February 2, 2026
Record last verified: 2026-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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