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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Annette C. Toledano MD
North Miami, Florida, United States
Mean Change from Baseline Period Mean in Average Pain Intensity at Weeks 9-12
The Brief Pain Inventory measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline to Weeks 9-12
Mean Change from Baseline Period Mean in BPI-S Measurements (Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Right-Now Pain Intensity, and Night Pain Intensity)
The Brief Pain Inventory - Severity measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12
Mean Change from Baseline Period Mean in BPI-I Measurements (General Activity, Mood, Chewing Ability, Normal Work, Relationships, Sleep Quality, Enjoyment of Life, Talking, and Teeth Brushing)
The Brief Pain Inventory - Interference measures interference with the listed activities on an 11-point Likert Scale from 0 (does not interfere) to 10 (completely interferes)).
Time frame: Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12
Patient Global Impression of Improvement
The PGI-I measures subject's assessment of how much relief the study medication provides on a scale of 0% to 100%, in increments of 10%.
Time frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12
Responder Analysis of CGI-S
The Clinical Global Impression - Severity scale measures the severity of the subject's condition on a seven point scale: normal, borderline, mild, moderate, marked, severe, or extreme
Time frame: Week 1, Week 4, Week 8, Week 12
Responder Analysis of CGI-I
The Clinical Global Impression - Improvement scale measures the improvement of the subject's condition on a seven-point Likert scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
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Time frame: Week 1, Week 4, Week 8, Week 12
Number of Doses of Additional Pain Medication Taken
The amount of additional analgesic medication needed for rescue purposes.
Time frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12
AFP Pain Disability Index
The AFP Disability Index assesses the disability caused by AFP in various life activities. It is scored on a scale of 0-100.
Time frame: Week 1, Week 4, Week 8, Week 12
Pittsburgh Insomnia Rating Scale 20
The PIRS-20 assesses the difficulty the subject has had with sleeping in the previous week. It is scored on a scale of 0-60.
Time frame: Week 1, Week 4, Week 8, Week 12