drugset / Trial / NCT03865940

Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy

NCT03865940

Phase 2 Completed 37 enrolled Vanderbilt University Medical Center
RandomizedCrossoverTriple-blindTreatment

Summary

A phenome-wide association study (PheWAS) identified an association between a loss of function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors. The objectives of the study will be to evaluate the efficacy and safety of guanfacine in combination with lidocaine for trigeminal nerve block procedures for pain management in trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in reducing acute pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected at specific time points after each injection.

Timeline

Start
2019-11-04
Primary completion
2023-10-04
Completion
2024-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule 250 ug Other
Subject Lidocaine Other / unclassified 1 % Other
Subject Lidocaine Other / unclassified 6 ml Other

Indications