Guanfacine for Trigeminal Neuralgia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Trigeminal Neuralgia+2 More
Guanfacine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: up to 2 weeks

up to 2 weeks
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
Time to first rescue medication during follow-up
Time to return to baseline pain after injection.
Total amount of rescue medications during follow-up

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Group 3: Guan-Guan+DMPH
36%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
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00429273) in the Group 3: Guan-Guan+DMPH ARM group. Side effects include: Decreased Appetite with 36%, Insomnia with 34%, Headache with 33%, Irritability with 26%, Abdominal Pain with 23%.

Trial Design

2 Treatment Groups

Lidocaine then Lidocaine + Guanfacine
1 of 2
Lidocaine + Guanfacine then Lidocaine
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Guanfacine · No Placebo Group · Phase 2

Lidocaine then Lidocaine + GuanfacineExperimental Group · 2 Interventions: Guanfacine, Lidocaine · Intervention Types: Drug, Drug
Lidocaine + Guanfacine then LidocaineExperimental Group · 2 Interventions: Guanfacine, Lidocaine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guanfacine
FDA approved
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 weeks

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
768 Previous Clinical Trials
592,051 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

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced pain in the past 24 hours before procedural treatment and at the time of procedural treatment.
You have a history of painful trigeminal neuropathy with persistent background facial pain severity > 5/10 on VAS.
You are eligible for the study if you have not had a trigeminal nerve block procedure for pain management prior to enrollment in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Alabama25.0%
Vermont25.0%
New York25.0%
Other25.0%
How old are they?
18 - 6575.0%
65+25.0%
What site did they apply to?
Vanderbilt University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%

How responsive is this trial?

Most responsive sites:
  1. Vanderbilt University Medical Center: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days