Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain

NCT01920087 | Withdrawn Phase 2

• 1 other identifier: AFP-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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)

  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)

  Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12

• Patient Global Impression of Improvement

  Weeks 1-4, Weeks 5-8, and Weeks 9-12

• Responder Analysis of CGI-S

  Week 1, Week 4, Week 8, Week 12

• Responder Analysis of CGI-I

  Week 1, Week 4, Week 8, Week 12

Study Arms (2)

ATNC05

EXPERIMENTAL

Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.

Drug: ATNC05

Placebo

PLACEBO COMPARATOR

Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks.

Drug: Placebo

Interventions

ATNC05 DRUG

Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.

ATNC05

Placebo DRUG

Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allodynic Therapeutics, Inc: lead

Study Sites (1)

Annette C. Toledano MD

North Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Facial Pain; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 9, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

US (1)