Clinical Trial: Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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 Non

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Allodynic Therapeutics, LLC

Current Primary Outcome: Mean Change from Baseline Period Mean in Average Pain Intensity at Weeks 9-12 [ Time Frame: Baseline to 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).


Original Primary Outcome: Mean Change from Baseline Period Mean in Average Pain Intensity at Week 3 [ Time Frame: Baseline to Week 3 ]

The Brief Pain Inventory measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).


Current Secondary Outcome:

  • 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) [ Time Frame: Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12 ]
    The Brief Pain Inventory - Severity measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).
  • 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) [ Time Frame: Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12 ]
    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)).
  • Patient Global Impression of Improvement [ Time Frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12 ]
    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%.
  • Responder Analysis of CGI-S [ Time Frame: Week 1, Week 4, Week 8, Week 12 ]
    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
  • Responder Analysis of CGI-I [ Time Frame: Week 1, Week 4, Week 8, Week 12 ]
    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.
  • Number of Doses of Additional Pain Medication Taken [ Time Frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12 ]
    The amount of additional analgesic medication needed for rescue purposes.
  • AFP Pain Disability Index [ Time Frame: Week 1, Week 4, Week 8, Week 12 ]
    The AFP Disability Index assesses the disability caused by AFP in various life activities. It is scored on a scale of 0-100.
  • Pittsburgh Insomnia Rating Scale 20 [ Time Frame: Week 1, Week 4, Week 8, Week 12 ]
    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.


Original Secondary Outcome:

  • 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) [ Time Frame: Baseline to Week 1, Week 2, and Week 3 ]
    The Brief Pain Inventory - Severity measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).
  • 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) [ Time Frame: Baseline to Week 1, Week 2, and Week 3 ]
    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)).
  • Patient Global Impression of Improvement [ Time Frame: Week 1, Week 2, and Week 3 ]
    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%.
  • Responder Analysis of CGI-S [ Time Frame: Post Initial Dose, Week 1, and Week 3 ]
    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
  • Responder Analysis of CGI-I [ Time Frame: Post-Initial Dose, Week 1, Week 3 ]
    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.
  • Number of Doses of Additional Pain Medication Taken [ Time Frame: Week 1, Week 2, and Week 3 ]
    The amount of additional analgesic medication needed for rescue purposes.
  • Trigeminal Neuralgia Pain Disability Index [ Time Frame: Week 1 and Week 3 ]
  • Pittsburgh Insomnia Rating Scale 20 [ Time Frame: Week 1 and Week 3 ]
  • Change from Baseline Period Mean in Tenderness in Temporomandibular Joint Node [ Time Frame: Baseline to Week 1 and Week 3 ]
    Tenderness is measured on an 11-point Likert Scale from 0 (no tenderness/pain) to 10 (worst pain imaginable) when manual pressure is applied by the investigator.


Information By: Allodynic Therapeutics, LLC

Dates:
Date Received: August 8, 2013
Date Started: March 2014
Date Completion: July 2016
Last Updated: March 12, 2014
Last Verified: March 2014