Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain (AFP)
Primary Purpose
Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATNC05
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atypical Facial Pain focused on measuring Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia, Orofacial Pain, Orofacial neuropathic pain, Fothergill Disease, Tic Douloureux, Prosopalgia
Eligibility Criteria
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.
Sites / Locations
- Annette C. Toledano MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ATNC05
Placebo
Arm Description
Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.
Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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)).
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%.
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
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.
Number of Doses of Additional Pain Medication Taken
The amount of additional analgesic medication needed for rescue purposes.
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.
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.
Full Information
NCT ID
NCT01920087
First Posted
August 8, 2013
Last Updated
March 12, 2014
Sponsor
Allodynic Therapeutics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01920087
Brief Title
Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
Acronym
AFP
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allodynic Therapeutics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia, Neuropathic Orofacial Pain, Neuropathic Facial Pain
Keywords
Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia, Orofacial Pain, Orofacial neuropathic pain, Fothergill Disease, Tic Douloureux, Prosopalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATNC05
Arm Type
Experimental
Arm Description
Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.
Intervention Type
Drug
Intervention Name(s)
ATNC05
Intervention Description
Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
Primary Outcome Measure Information:
Title
Mean Change from Baseline Period Mean in Average Pain Intensity at Weeks 9-12
Description
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
Secondary Outcome Measure Information:
Title
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)
Description
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
Title
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)
Description
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
Title
Patient Global Impression of Improvement
Description
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
Title
Responder Analysis of CGI-S
Description
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
Title
Responder Analysis of CGI-I
Description
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.
Time Frame
Week 1, Week 4, Week 8, Week 12
Title
Number of Doses of Additional Pain Medication Taken
Description
The amount of additional analgesic medication needed for rescue purposes.
Time Frame
Weeks 1-4, Weeks 5-8, and Weeks 9-12
Title
AFP Pain Disability Index
Description
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
Title
Pittsburgh Insomnia Rating Scale 20
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Annette C. Toledano MD
City
North Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States
12. IPD Sharing Statement
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Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
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