Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Change in pain score [Daily, from Baseline through Day 180]
Pt. reported 0-10 analog pain scale
- Change in use of rescue and other anti-pain medications [Daily, from Baseline through Day 180]
Pt. reported, any use of anti-pain medication
- Number of adverse events, by type and severity [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
- Change in circadian rhythm impairment [Daily, from Baseline through Day 180]
Based on data from Wearable Sleep Monitor
- Change in subject's pain/inflammation markers [Day 0, Day 45, Day 75 and Day 105]
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 [Day 0]
Genomic DNA testing
Eligibility Criteria
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:
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
- Eli Lilly and Company
Investigators
- Principal Investigator: Sweta Sengupta, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00103776