Clinical trial NCT04158752: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trigeminal Neuralgia
Glossopharyngeal Neuralgia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2019-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in pain score
timeFrame: Daily, from Baseline through Day 180
measure: Change in use of rescue and other anti-pain medications
timeFrame: Daily, from Baseline through Day 180
measure: Number of adverse events, by type and severity
timeFrame: Collected through Day 180
Secondary outcomes:
measure: Change in circadian rhythm impairment
timeFrame: Daily, from Baseline through Day 180
measure: Change in subject's pain/inflammation markers
timeFrame: Day 0, Day 45, Day 75 and Day 105
measure: Presence or absence of DNA polymorphisms that predispose treated patients to accentuated responses of either lack of response or particularly potent response
timeFrame: Day 0
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Sweta Sengupta, MD
role: PRINCIPAL_INVESTIGATOR
References: