Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
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.
Inclusion Criteria:

 -  The patient is at least 18 years but no more than 89 years of age

 -  The patient has atypical facial pain/persistent idiopathic facial pain, as diagnosed
 by the 2nd Edition of The International Headache Classification (ICHD-2), section
 13.18.4.

 -  The patient has constant pain in the face, persisting for all or most of the day (four
 or more hours per day) and present four days or more per week, with a severity of 5 or
 more (11-point scale, 0 = no pain, 10 = worst pain imaginable).

 -  The pain is chronic, present for at least six months.

 -  The patient's pain is confined at onset to a limited area on one side of the face, and
 is deep and poorly localized.

 -  The patient's pain is not associated with sensory loss or other physical signs, and
 diagnostic studies of face and jaws do not demonstrate any relevant abnormality.

 -  Patient must be willing to refrain from opioid medications during the course of the
 trial.

 -  Patients entering the study on other approved concomitant medications for pain (e.g.,
 NSAIDS, anticonvulsants, antidepressants) must continue them as a stable regimen for
 at least two weeks prior to Pre-Screening and throughout the study period.

 -  The patient must agree to limit their rescue medications to APAP (Paracetamol/
 acetaminophen).

 -  The patient must understand and be willing to cooperate with the study instructions,
 including attendance of all scheduled office visits and returning unused medication
 and vials.

 -  If the patient is a female, she must be post-menopausal, not currently pregnant or
 nursing, and using a reliable contraception method (e.g., intrauterine device (IUD),
 oral or deport contraceptive, or barrier (i.e., condom or diaphragm plus spermicide).

 -  The patient must sign an informed consent document indicating willingness to
 participate.

 Exclusion Criteria:

 -  The patient has predominantly paroxysmal facial pain consistent with the diagnosis of
 classical trigeminal neuralgia or symptomatic trigeminal neuralgia.

 -  The patient's facial pain has an identifiable cause.

 -  The patient has a positive urine drug screen during the screening visit.

 -  The patient has a history of substance abuse and/or dependency (including but not
 limited to opioid and/or alcohol dependence).

 -  The patient has been on chronic opioid therapy or has taken opioid medication ≤ 7 days
 prior Pre-Screening.

 -  The subject has a history of significant neurological, hepatic, renal, endocrine,
 cardiovascular, gastrointestinal, pulmonary, or metabolic disease. The subject has
 acute hepatitis or liver failure.

 -  The subject has a history of left ventricular hypertrophy, recent MI, angina,
 palpitations, dyspnea, or arrhythmia.

 -  The subject has used MAO Inhibitors within 30 days of enrollment.

 -  The patient has a history of an allergic reaction to the components in the trial
 medication.

 -  The patient is pregnant or breastfeeding.

 -  The patient has a heart rate of less than 60 beats per minute and/or systolic blood
 pressure of 90 mmHg or lower at Screening and/or medication initiation visit.

 -  The patient has another source of pain that is greater than AFP.