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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Injection of study drug at 3 timepoints (day 30, day 60, day 90)
Duke University
Durham, North Carolina, United States
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.
Time frame: 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.
Time frame: 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).
Time frame: Collected through Day 180
Change in Level of TNF-alpha as a Marker of Pain or Inflammation
Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum
Time frame: Baseline, Day 180
Change in Level of IL-6 as a Marker of Pain or Inflammation
Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum
Time frame: Baseline, Day 180
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