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Local Anesthetic

Guanfacine + Lidocaine for Trigeminal Neuralgia

Phase 2
Waitlist Available
Led By Tigran Kesayan, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of painful trigeminal neuropathy with persistent background facial pain severity > 5/10 on VAS
Experience pain with a score of greater than 5 on a 0-10 scale (VAS) in the previous 24 hours before procedural treatment and at the time of procedural treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights

Study Summary

This trial will test whether guanfacine is an effective treatment for trigeminal neuralgia by reducing pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block.

Eligible Conditions
  • Trigeminal Neuralgia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a history of persistent facial pain rated above 5 out of 10 on a pain scale.
Select...
You have had pain rated as 6 or higher on a 0-10 scale in the past day before and during the treatment.
Select...
You are able to have a nerve block procedure for pain and have not had this procedure before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to return to baseline pain after injection.
Secondary outcome measures
Frequency of acute trigeminal nerve pain attacks during follow-up
Pain intensity after treatment to be measured throughout follow-up
Quality of life after treatment
+2 more

Side effects data

From 2011 Phase 4 trial • 212 Patients • NCT00429273
36%
Decreased Appetite
34%
Insomnia
33%
Headache
26%
Irritability
23%
Sedation
23%
Abdominal Pain
23%
Lethargy
21%
Somnolence
17%
Fatigue
14%
Abdominal Pain Upper
11%
Affect Lability
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Guan-Guan+Placebo
Group 2: Placebo-Placebo+DMPH
Group 3: Guan-Guan+DMPH

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lidocaine then Lidocaine + GuanfacineExperimental Treatment2 Interventions
Trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine (Day 1). Patient will return between Day 15-28 and trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine + 250 mcg guanfacine.
Group II: Lidocaine + Guanfacine then LidocaineExperimental Treatment2 Interventions
Trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine + 250 mcg guanfacine (Day 1). Patient will return between Day 15-28 and trigeminal nerve block will be performed with injection of 6 mL of 1% lidocaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guanfacine
2008
Completed Phase 4
~2180
Lidocaine
2011
Completed Phase 4
~1360

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
669,091 Total Patients Enrolled
Tigran Kesayan, MDPrincipal InvestigatorVanderbilt University Medical Center
David EdwardsPrincipal Investigator - Vanderbilt University Medical Center
Centennial Medical Center-Women's Hospital, Sterling Primary Care, Sterling Primary Care Associates LLC, TriStar Centennial Medical Center, TriStar Parthenon Pavilion
University Of North Carolina At Chapel Hill School Of Medicine (Medical School)
Vanderbilt University Medical Center (Residency)
1 Previous Clinical Trials
625 Total Patients Enrolled

Media Library

Lidocaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03865940 — Phase 2
Trigeminal Neuralgia Research Study Groups: Lidocaine + Guanfacine then Lidocaine, Lidocaine then Lidocaine + Guanfacine
Trigeminal Neuralgia Clinical Trial 2023: Lidocaine Highlights & Side Effects. Trial Name: NCT03865940 — Phase 2
Lidocaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865940 — Phase 2
Trigeminal Neuralgia Patient Testimony for trial: Trial Name: NCT03865940 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Alabama
Vermont
West Virginia
Other
How old are they?
65+
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

How long do visits last?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I’ve been on trileptal and keep praying for years. End of February had a cervical ablation. That helped for a few weeks. Cannot repeat ablation till August.
PatientReceived 1 prior treatment
I've had a rhizotimy with numbness on left side. In the last 2 months the right side is now struggling with TN. I've had a nerve block on right side with no success.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Vanderbilt University Medical Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~7 spots leftby Mar 2025