Phase 4
N=20
Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
Trigeminal Neuralgia · Glossopharyngeal Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT04158752 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change in Pain Score — -0.6224; -1.005; -0.8102; -1.079 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Galcanezumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score |
-0.6224; -1.005; -0.8102; -1.079; -0.3827; -0.1877 | — |
| PRIMARY Number of Participants With a Change in Use of Anti-pain Medication |
3; 4; 13 | — |
| PRIMARY Total Number of Adverse Events by Severity |
29; 5; 0; 0; 0 | — |
| SECONDARY Change in Level of TNF-alpha as a Marker of Pain or Inflammation |
0.2 | — |
| SECONDARY Change in Level of IL-6 as a Marker of Pain or Inflammation |
3.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04158752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.