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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
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 moreSide effects data
From 2011 Phase 4 trial • 212 Patients • NCT0042927336%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of persistent facial pain rated above 5 out of 10 on a pain scale.You have a visible tumor or other significant issue in your brain causing the pain, as seen in a brain scan.You have been diagnosed with fibromyalgia, temporomandibular disorders (TMD), or other types of facial pain not related to the trigeminal nerve.You are able to have a nerve block procedure for pain and have not had this procedure before joining the study.You are allergic to guanfacine, lidocaine, or certain types of contrast dye used in medical imaging.You have had pain rated as 6 or higher on a 0-10 scale in the past day before and during the treatment.You have a history of ongoing facial pain that is very intense.You have had significant pain in the last 24 hours before the treatment.You can have a procedure to block the trigeminal nerve for pain relief, but you haven't had this procedure before joining this study.You have a history of ongoing facial pain that is very intense.You have had pain with a score higher than 5 out of 10 in the past 24 hours and at the time of the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lidocaine + Guanfacine then Lidocaine
- Group 2: Lidocaine then Lidocaine + Guanfacine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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:
- Vanderbilt University Medical Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
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