Temporomandibular DisorderPhase 2NCT04884763

Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder

A Phase 2 study testing Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments in people with Temporomandibular Disorder, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this proof of concept study is to evaluate the safety and efficacy of the off-label use of Aimovig® (EREN) in reducing Temporomandibular Disorder (TMD) pain compared to placebo. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Temporomandibular Disorder
What is being tested?: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2021to 4 Jan 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects eligible for inclusion in the study must meet all of the following criteria:
Signed the informed consent;
Have pain-related TMD myalgia assessed by history and clinical examination as established by the DC/TMD;
Age 18 years and younger than 60 years;
Have a good knowledge of the English language;
Able to understand and comply with the study requirements;
Have had TMD myalgia for 6 months or longer; and
If taking pain medications, the dose regimen must be stable for at least 4 weeks prior to the screening visit.

Who cannot join

Subjects meeting any of the following criteria are not eligible for inclusion:
Lacking stable bilateral posterior occlusion;
Currently uses a complete maxillary or mandibular prosthetic denture;
Currently pregnant or plan to become pregnant;
Breastfeeding or plan to breastfeed;
Allergic to erenumab-aooe or any of the ingredients in Aimovig® (acetate, polysorbate 80, and sucrose);

Show all 22Show fewer

Allergic to rubber or latex;
Currently undergoing TMD treatment elsewhere;
Currently undergoing orthodontic treatment;
Currently included in other experimental protocols within the last 30 days before enrollment;
Having 11 or more headaches during the past 4 weeks;
Having received massage, acupuncture or physical therapy treatment of the head, neck or shoulders during the previous 3 months;
History of unstable or acute severe pain from another pain condition;
History of traumatic brain injury;
History of surgical treatment or recommended surgical treatment for TMD;
History of ongoing, unresolved disability litigation;
History of drug abuse;
History of moderate to severe sleep apnea requiring CPAP or oral mandibular repositioning appliance;
Anything that would place the subjects at increased risk or preclude the individual's full compliance with or completion of the study (e.g., medical condition, laboratory finding, physical exam finding logistical complication); and
History of previously receiving erenumab-aooe or other anti-CGRP therapies, including anti-CGRP and anti-CGRP receptor monoclonal antibodies and small molecule CGRP receptor antagonists (gepants).
History of chronic constipation and/or using medication associated with decreased gastrointestinal motility.
History of hypertension or risk factors for hypertension.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled Single Center Phase 2 Pilot Study to Assess the Safety and Efficacy of Off-label Subcutaneous Administration of Erenumab-aooe in Patients With Temporomandibular Disorder

The purpose of this proof of concept study is to evaluate the safety and efficacy of the off-label use of Aimovig® (EREN) in reducing Temporomandibular Disorder (TMD) pain compared to placebo.

Read the detailed description

This will be a 24-week, randomized, double-blinded, placebo-controlled, parallel group proof-of-concept study with two arms (active and placebo). The plan is to enroll 30 subjects. There will be a four-week screening period to identify subjects that meet the diagnostic criteria (DC/TMD) for "myalgia", recommended by the International RDC/TMD Consortium Network and Orofacial Pain Special Interest Group. The Diagnostic Criteria for Temporomandibular Disorders Symptom Questionnaire and DC/TMD Examination Form will be used during Screening and Baseline visits to confirm the TMD diagnosis and determine whether subjects meet the inclusion/exclusion criteria.

Subjects will attend a Screening visit followed by Baseline visit to randomize eligible subjects to active (EREN) or placebo (EREN-P). During the Baseline visit and Wks 4, 8, 12, and 16, subjects will receive treatment with either 140 mg of EREN or Placebo administered by subcutaneous injection. At Baseline and Wks 4, 8, 12, 16, 20, and 24 subjects will be instructed to complete the Brief Pain Inventory (BPI); PEG (Pain, Enjoyment, General Activity) Scale; pain mediation assessment; Patient Global Impression of Change (PGIC) (except for Baseline visit); Jaw Function Limitation Scale (JFLS); Patient Health Questionnaire (PHQ-4); and Somatic Symptom Scale (SSS-8). These visits will include review of continuance criteria and adverse event collection.

At the Screening and Baseline visits the subjects will be instructed on how to use the PEG Scale and pain use assessment app, which will be downloaded on their smartphone, to provide a daily assessment of their pain intensity and interference with enjoyment and general activity (PEG) and their daily used of pain medications. Subjects who do not own a smartphone or are unwilling to use the app on a daily basis will only complete the PEG and pain medication assessment at the Baseline visit and all subsequent visits using the app onsite.

Conditions: Temporomandibular Disorder
Being tested: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments, Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatmentsDrug
Also called Aimovig®
Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Placebo (EREN-P) s.c. administered every four weeks for a total of five treatmentsDrug
Also called Placebo
Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments

Study groups in NCT04884763
Study group	Role	What they receive
Arm A	Active comparator	Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Receives: Drug: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments
Arm B	Placebo comparator	Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Receives: Drug: Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain Inventory (BPI) Pain Severity at 20 Weeks
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).
Measured: 20 weeks.

Secondary outcomes (15)

Brief Pain Inventory (BPI) Pain Interference at 20 Weeks
Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Average Daily Reported Pain Scores at 20 Weeks
Assessment of pain using average of daily reported pain scores at 20 weeks; average of daily reported scores from days > week 16 and <= week 20. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
% of Days Taking Medication for Pain at 20 Weeks
Assessment of pain using the % of days taking medication for pain at 20 weeks; percentage of days calculated from days > week 16 and <= week 20.Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks
Assessment of pain improvement using the patient global impression of change in pain scale at 20 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Jaw Function Limitation Scale (JFLS-8) at 20 Weeks
Jaw Function Limitation Scale (JFLS-8) at 20 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Patient Health Questionnaire (PHQ-4) at 20 Weeks
Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 20 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Somatic Symptoms Scale (SSS-8) at 20 Weeks
Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 20 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).
Measured: 20 weeks
Brief Pain Inventory (BPI) Pain Severity at 24 Weeks
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (primary outcome).
Measured: 24 weeks.
Brief Pain Inventory (BPI) Pain Interference at 24 Weeks
Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
Average Daily Reported Pain Scores at 24 Weeks
Assessment of pain using average of daily reported pain scores at 24 weeks; average of daily reported scores from days > week 20 and <= week 24. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
% of Days Taking Medication for Pain at 24 Weeks
Assessment of pain using the % of days taking medication for pain at 24 weeks; percentage of days calculated from days > week 20 and <= week 24. Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
Pain Improvement Using the Patient Global Impression of Change in Pain at 24 Weeks
Assessment of pain improvement using the patient global impression of change in pain scale at 24 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
Jaw Function Limitation Scale (JFLS-8) at 24 Weeks
Jaw Function Limitation Scale (JFLS-8) at 24 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
Patient Health Questionnaire (PHQ-4) at 24 Weeks
Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 24 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks
Somatic Symptoms Scale (SSS-8) at 24 Weeks
Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 24 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20214 Jan 2024

First posted13 May 2021
Study start15 Nov 2021
Primary completion4 Jan 2024
Study completion4 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04884763
Sponsor's protocol ID: 20-D-242
Other IDs: CAMG334AUS01T
Status last verified: Jul 2025
First submitted: 4 May 2021
Last updated: 19 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
PubMed 31146544
de Leeuw, R, Editor, Orofacial Pain: Guidelines for Assessment, Diagnosis, and Management, The American Academy of Orofacial Pain, Sixth Edition, Hanover Park, IL: Quintessence Publishing Co, Inc., 2018, 1-2
Edvinsson L. The CGRP Pathway in Migraine as a Viable Target for Therapies. Headache. 2018 May;58 Suppl 1:33-47. doi: 10.1111/head.13305.
PubMed 29697153
Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
PubMed 29171821
Hargreaves R, Olesen J. Calcitonin Gene-Related Peptide Modulators - The History and Renaissance of a New Migraine Drug Class. Headache. 2019 Jun;59(6):951-970. doi: 10.1111/head.13510. Epub 2019 Apr 25.
PubMed 31020659
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical statistics. 2005;4:287-291.
Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497.
PubMed 26807536
Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
PubMed 19418100
Kroenke K, Evans E, Weitlauf S, McCalley S, Porter B, Williams T, Baye F, Lourens SG, Matthias MS, Bair MJ. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics. Contemp Clin Trials. 2018 Jan;64:179-187. doi: 10.1016/j.cct.2017.10.006. Epub 2017 Oct 12.
PubMed 29031492
Kroenke K, Krebs EE, Turk D, Von Korff M, Bair MJ, Allen KD, Sandbrink F, Cheville AL, DeBar L, Lorenz KA, Kerns RD. Core Outcome Measures for Chronic Musculoskeletal Pain Research: Recommendations from a Veterans Health Administration Work Group. Pain Med. 2019 Aug 1;20(8):1500-1508. doi: 10.1093/pm/pny279.
PubMed 30615172
Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
PubMed 19996233
Maixner W, Fillingim RB, Williams DA, Smith SB, Slade GD. Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification. J Pain. 2016 Sep;17(9 Suppl):T93-T107. doi: 10.1016/j.jpain.2016.06.002.
PubMed 27586833
Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, cortical spreading depression, sensitization, and modulation of pain. Pain. 2013 Dec;154 Suppl 1:S44-53. doi: 10.1016/j.pain.2013.07.021. Epub 2013 Jul 25.
PubMed 23891892
Ohrbach, R, editor. Diagnostic Criteria for Temporomandibular Disorders Assessment Instruments. Version 15May2016. www.rdc-tmdinternational.org Accessed on 23Sep2019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Temporomandibular Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-Controlled Single Center Phase 2 Pilot Study to Assess the Safety and Efficacy of Off-label Subcutaneous Administration of Erenumab-aooe in Patients With Temporomandibular Disorder
ClinicalTrials.gov ID: NCT04884763
Acronym / sponsor ID: 20-D-242
Conditions: Temporomandibular Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Amgen
Study start: 15 Nov 2021 (actual)
Primary completion: 4 Jan 2024 (actual)
Study completion: 4 Jan 2024 (actual)
First posted: 13 May 2021 (actual)
Results: Posted 19 Aug 2025

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 this proof of concept study is to evaluate the safety and efficacy of the off-label use of Aimovig® (EREN) in reducing Temporomandibular Disorder (TMD) pain compared to placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A	Active comparator	Drug: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatmentsArm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments
Arm B	Placebo comparator	Drug: Placebo (EREN-P) s.c. administered every four weeks for a total of five treatmentsArm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Signed the informed consent;
Have pain-related TMD myalgia assessed by history and clinical examination as established by the DC/TMD;
Age 18 years and younger than 60 years;
Have a good knowledge of the English language;
Able to understand and comply with the study requirements;

Key exclusion criteria (22 listed)

Lacking stable bilateral posterior occlusion;
Currently uses a complete maxillary or mandibular prosthetic denture;
Currently pregnant or plan to become pregnant;
Breastfeeding or plan to breastfeed;
Allergic to erenumab-aooe or any of the ingredients in Aimovig® (acetate, polysorbate 80, and sucrose);

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
Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatmentsAlso: Aimovig®Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Drug	Arm A
Placebo (EREN-P) s.c. administered every four weeks for a total of five treatmentsAlso: PlaceboPlacebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Drug	Arm B

Primary outcome

Brief Pain Inventory (BPI) Pain Severity at 20 Weeks
Time frame: 20 weeks.
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).

15 secondary outcomes

Brief Pain Inventory (BPI) Pain Interference at 20 Weeks
Time frame: 20 weeks
Average Daily Reported Pain Scores at 20 Weeks
Time frame: 20 weeks
% of Days Taking Medication for Pain at 20 Weeks
Time frame: 20 weeks
Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks
Time frame: 20 weeks
Jaw Function Limitation Scale (JFLS-8) at 20 Weeks
Time frame: 20 weeks
Patient Health Questionnaire (PHQ-4) at 20 Weeks
Time frame: 20 weeks
Somatic Symptoms Scale (SSS-8) at 20 Weeks
Time frame: 20 weeks
Brief Pain Inventory (BPI) Pain Severity at 24 Weeks
Time frame: 24 weeks.
Brief Pain Inventory (BPI) Pain Interference at 24 Weeks
Time frame: 24 weeks
Average Daily Reported Pain Scores at 24 Weeks
Time frame: 24 weeks
% of Days Taking Medication for Pain at 24 Weeks
Time frame: 24 weeks
Pain Improvement Using the Patient Global Impression of Change in Pain at 24 Weeks
Time frame: 24 weeks
Jaw Function Limitation Scale (JFLS-8) at 24 Weeks
Time frame: 24 weeks
Patient Health Questionnaire (PHQ-4) at 24 Weeks
Time frame: 24 weeks
Somatic Symptoms Scale (SSS-8) at 24 Weeks
Time frame: 24 weeks

Results and safety

Results posted to the registry on 19 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	15	10
Arm B	15	12

Primary outcome: Brief Pain Inventory (BPI) Pain Severity at 20 Weeks

Time frame: 20 weeks.. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Arm A n = 15	Arm B n = 15
Value	1.72 (0.78 to 2.65)	1.42 (0.55 to 2.29)

Arm A vs Arm B: Mean Difference (Final Values): 0.30 (95% CI -0.76 to 1.35), p = 0.567, Mixed Models Analysis

Population analysed: Estimation done using mixed-model ANOVA which includes all available data from all time points for all subjects. This analysis reduces bias compared to an analysis at each time point that excludes subjects with missing data. All study subjects were included, even if they did not have data observed at the given time point. In addition to missing data shown in Participant Flow table, outcome-specific missing data for 1 additional Arm A subject at week 12 and 2 additional Arm B subjects at week 20.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 15 (0%)	9 of 15 (60%)	0 of 15
Arm B	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31146544Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
Backgroundde Leeuw, R, Editor, Orofacial Pain: Guidelines for Assessment, Diagnosis, and Management, The American Academy of Orofacial Pain, Sixth Edition, Hanover Park, IL: Quintessence Publishing Co, Inc., 2018, 1-2
Background: PubMed 29697153Edvinsson L. The CGRP Pathway in Migraine as a Viable Target for Therapies. Headache. 2018 May;58 Suppl 1:33-47. doi: 10.1111/head.13305.
Background: PubMed 29171821Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
Background: PubMed 31020659Hargreaves R, Olesen J. Calcitonin Gene-Related Peptide Modulators - The History and Renaissance of a New Migraine Drug Class. Headache. 2019 Jun;59(6):951-970. doi: 10.1111/head.13510. Epub 2019 Apr 25.
Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical statistics. 2005;4:287-291.
Background: PubMed 26807536Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497.
Background: PubMed 19418100Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
Background: PubMed 29031492Kroenke K, Evans E, Weitlauf S, McCalley S, Porter B, Williams T, Baye F, Lourens SG, Matthias MS, Bair MJ. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics. Contemp Clin Trials. 2018 Jan;64:179-187. doi: 10.1016/j.cct.2017.10.006. Epub 2017 Oct 12.
Background: PubMed 30615172Kroenke K, Krebs EE, Turk D, Von Korff M, Bair MJ, Allen KD, Sandbrink F, Cheville AL, DeBar L, Lorenz KA, Kerns RD. Core Outcome Measures for Chronic Musculoskeletal Pain Research: Recommendations from a Veterans Health Administration Work Group. Pain Med. 2019 Aug 1;20(8):1500-1508. doi: 10.1093/pm/pny279.
Background: PubMed 19996233Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
Highlights of Prescribing InformationLink provided by the sponsor.

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Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

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.

Domenick T Zero, DDS, MS principal investigator

Indiana University

Harold C Avila, DDS, MS principal investigator

Indiana University

Kurt Kroenke, MD, MACP principal investigator

Regenstrief Institute, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 22 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: finished, as of the sponsor's last update on 19 Aug 2025. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brief Pain Inventory (BPI) Pain Severity at 20 Weeks (time frame: 20 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884763, which also lists 24 linked publications.

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 19 Aug 2025.