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Local Anesthetic
Guanfacine + Lidocaine for Trigeminal Neuralgia
Phase 2
Waitlist Available
Led By David Edwards
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if guanfacine can make lidocaine more effective in reducing facial pain for patients with trigeminal neuralgia by making the pain relief last longer. Guanfacine is primarily used for treating ADHD and has been found to help with symptoms in children.
Eligible Conditions
- Trigeminal Neuralgia
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Return to Baseline Pain After Injection.
Secondary study objectives
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%
Abdominal Pain
23%
Sedation
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1370
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
934,042 Total Patients Enrolled
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
Tigran Kesayan, MDPrincipal InvestigatorVanderbilt University Medical Center
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 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.
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