CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Lidocaine 6 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03865940
NCT03865940Phase 2Completed

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

Vanderbilt University Medical Center·interventional·Posted Mar 7, 2019·Updated Mar 30, 2025

In Brief

A Phase 2 clinical trial evaluating Lidocaine and Guanfacine for Trigeminal Neuralgia. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 7, 2019
Enrollment StartNov 4, 2019
Primary CompletionOct 4, 2023
Study CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.3 years ago

Interventions

Lidocainedrug

6 mL of 1% lidocaine

Guanfacinedrug

250 mcg