Atypical Facial PainPhase 2/3AFPNCT01920087
Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
A Phase 2/3 study testing ATNC05 in people with Atypical Facial Pain and Persistent Idiopathic Facial Pain, run by Allodynic Therapeutics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia
- What is being tested?
- ATNC05
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia, Neuropathic Orofacial Pain, Neuropathic Facial Pain
- Being tested
- ATNC05, Placebo
- Keywords
- Atypical Facial Pain, Persistent Idiopathic Facial Pain, Atypical Trigeminal Neuralgia, Orofacial Pain, Orofacial neuropathic pain, Fothergill Disease, Tic Douloureux, Prosopalgia
- Medical subject headings
- Facial Pain, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATNC05Drug
Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
PlaceboDrug
Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| ATNC05 | Experimental | Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. Receives: Drug: ATNC05 |
| Placebo | Placebo comparator | Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The Brief Pain Inventory - Severity measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: 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)
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)).
Measured: 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%.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allodynic Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920087
- Sponsor's protocol ID
- AFP-001
- Acronym
- AFP
- Status last verified
- Mar 2014
- First submitted
- 8 Aug 2013
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01920087
- Acronym / sponsor ID
- AFP / AFP-001
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allodynic Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATNC05 | Experimental | Drug: ATNC05Once capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. |
| Placebo | Placebo comparator | Drug: PlaceboOnce capsule twice daily for first week of treatment. Two capsules at bedtime in subsequent weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATNC05Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol. | Drug | ATNC05 |
| PlaceboSubject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol. | Drug | Placebo |
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).
8 secondary outcomes
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
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
Patient Global Impression of Improvement
Time frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12
Responder Analysis of CGI-S
Time frame: Week 1, Week 4, Week 8, Week 12
Responder Analysis of CGI-I
Time frame: Week 1, Week 4, Week 8, Week 12
Number of Doses of Additional Pain Medication Taken
Time frame: Weeks 1-4, Weeks 5-8, and Weeks 9-12
AFP Pain Disability Index
Time frame: Week 1, Week 4, Week 8, Week 12
Pittsburgh Insomnia Rating Scale 20
Time frame: Week 1, Week 4, Week 8, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
Related trials for Atypical Facial Pain
Not yet recruitingObservational study
Deciphering Persistent Orofacial Pain - PIFP
Persistent Idiopathic Facial Pain (PIFP)
Enrolling by invitationObservational study
Treatment of Atypical Resistant Facial Pain
Facial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ATNC05 in people with Atypical Facial Pain and Persistent Idiopathic Facial Pain, run by Allodynic Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline Period Mean in Average Pain Intensity at Weeks 9-12 (time frame: Baseline to Weeks 9-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.