NCT03865940

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

A Randomized, Double-Blind, 2-Way Crossover Trial to Assess the Efficacy of Guanfacine and Lidocaine Combination Versus Lidocaine Alone in Trigeminal Nerve Block for Pain Management in Painful Trigeminal Neuropathy Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	Lidocaine	6 mL of 1% lidocaine
DRUG	Guanfacine	250 mcg

Timeline

• Start date: 2019-11-04
• Primary completion: 2023-10-04
• Completion: 2024-01-31
• First posted: 2019-03-07
• Last updated: 2025-03-30
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study