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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATNC05 | Experimental | Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. |
|
| Placebo | Placebo Comparator | Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATNC05 | Drug | Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Weeks 9-12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annette C. Toledano MD | North Miami | Florida | 33181 | United States |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol. |
|
| 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)). | 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%. | 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 | 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. | 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. | 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. | 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. | Week 1, Week 4, Week 8, Week 12 |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |