Atypical Facial Pain Clinical Trial
Official title:
Phase II Double Blind, Randomized, Placebo Controlled, Safety and Efficacy Study of ATNC05 in Patients With Atypical Facial Pain With an Open-Label Extension Phase for Nonresponders
The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research project targets patients with chronic constant facial pain and excludes patients with primarily paroxysmal pain.
ATNC05 is a rational combination of two well-characterized drugs with decades of clinical
use. The investigators hypothesize that the combination acts synergistically to reduce AFP.
The trial consists of a double-blind treatment period of twelve weeks with either Placebo or
ATNC05. Subjects who do not respond to the study medication will continue on to a twelve
week Open-Label extension phase, during which they will receive ATNC05.
The subjects will have six office visits during the Double-Blind phase. Subjects continuing
to the Open-Label phase will have four additional visits.
Data gathering procedures include daily pain questionnaire forms, as well as questionnaires
and physical examination during office visits.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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