Glossopharyngeal Neuralgia, Trigeminal Neuralgia
Conditions
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.
Interventions
DRUGGalcanezumab
Injection of study drug at 3 timepoints (day 30, day 60, day 90)
Sponsors
Duke University
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days | Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints. |
| Number of Participants With a Change in Use of Anti-pain Medication | Baseline through Day 135 | Patient reported; any use of anti-pain medication. |
| Total Number of Adverse Events by 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. Adverse events can be classified into five severity grades (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of TNF-alpha as a Marker of Pain or Inflammation | Baseline, Day 180 | Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum |
| Change in Level of IL-6 as a Marker of Pain or Inflammation | Baseline, Day 180 | Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSweta Sengupta, MD
Duke University
Participant flow
Recruitment details
Participants were recruited based on physician referral from a tertiary medical center. The first participant was enrolled July 24, 2020, and last participant was enrolled June 28, 2022.
Pre-assignment details
Of the 26 enrolled, 20 patients met inclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 12.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 13 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed