Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)

NCT05162027 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HP-00093037
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD). The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo. A total of 60 patients (30 per each arm) aged 18-65 years old of either sex, and any race or ethnicity presenting chronic temporomandibular disorders (TMD), (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications of chronic TMD (myalgia +/- arthralgia) will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either erenumab-aooe or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks). Changes in pain intensity and other pain outcomes related to TMD will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

Conditions

Temporomandibular Disorders

Keywords

Craniomandibular Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Disorders; Erenumab; Myofascial Pain Syndromes; Physiological Effects of Drugs; Calcitonin Gene-Related Peptide Receptor Antagonists; Neuropeptides; CGRP Receptor Antagonist; Stomatognathic Diseases; Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

• Change of >= 30% Reduction in the Monthly Average Pain Score From Baseline to Visit 4, Compared to Placebo.

  Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly average pain score from baseline to Visit 4 (the end of last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 0-100 numeric rating scale (NRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline, Visit 1/Day 28/Week 4, Visit 2/Day 56/Week 8, Visit 3/Day 84/week 12 and Visit 4/Day 112/Week 16.

  From Visit 0 (Baseline phase/study day 0) to Visit 4 (study day 112)

Secondary Outcomes (15)

• Change of >= 50% Reduction in Monthly TMD Pain Days, Compared to Placebo.

  From Visit 0 (Baseline phase/study day 0) to Visit 5 (study day 140 +/- 7)

• Change of >= 30% Reduction in the Monthly Average Pain Score Compared to Placebo From Baseline to Visit 5.

  From Visit 0 (Baseline phase/study day 0) to Visit 5 (Study day 140 +/- 7)

• Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Temporalis Muscle) Compared to Placebo From Baseline to Visit 5.

  Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7)

• Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Masseter Muscle) Compared to Placebo From Baseline to Visit 5.

  Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7)

• Change in Pressure Pain Threshold (PPT) Measurement in Upper Trapezius Muscle Compared to Placebo From Baseline to Visit 5.

  Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7)

Other Outcomes (1)

• Change of Pro-inflammatory and Anti-inflammatory Cytokine Profiles (Th1/Th2) When Compared to Placebo.

  Visit 0 (Baseline/study day 0) and Visit 4/Week 16 (study day 112)

Study Arms (2)

Erenumab-aooe

ACTIVE COMPARATOR

Erenumab-aooe 70 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other Name: Aimovig®

Drug: Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe

Placebo

PLACEBO COMPARATOR

Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other name: Placebo

Drug: Placebo

Interventions

Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe DRUG

Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

Also known as: Aimovig

Erenumab-aooe

Placebo DRUG

Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

Placebo

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provide signed and dated informed consent form
• Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
• Meets diagnostic criteria for TMD: Myalgia with or without arthralgia
• The participant must meet 2 criteria relating: 1) reported pain, ache or tenderness in the face, jaw/mandible, pre-auricular area, inside the ear or temple that it is modified by TMJ biomechanics. 2) finding(s) of TMD myalgia according to the classification DC/TMD criteria.
• Has experienced facial pain and/or pain with TMJ biomechanics for the last 3 months episodically or unremitting
• Has experienced facial pain for at least 10 days of the last 30 days prior to Baseline Visit (Visit 0)
• Prior to randomization, has been compliant 80% with the entries in the Daily Symptom Diary within the baseline period and reported an average pain level ≥30 on a numerical rating scale (0-100) in the DSD, or has experienced a pain level ≥30 on the same scale for at least 3 days in the week prior to Visit 1.
• If taking a prescription medication daily for the management of pain (taken for at least 30 days before baseline), agrees to continue the daily use of the medication throughout the study at the same dosage.
• If taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of TMD pain agrees to discontinue its use prior to the Screening and Baseline Visit.
• Rescue medications will be defined as allowable over-the-counter analgesics used for treatment of TMD pain. In case a patient presents pain during the study, only it is allowed the use of OTC medications as a "rescue" and as described on section 6.6.3: Participants use of short-acting non-prescription analgesics such as NSAIDs, acetaminophen or aspirin during the study, will be recorded and quantified at each visit, and the usage will be classified as either episodic or daily. Episodic use of non-prescription analgesics will be defined as use for no more than 2 consecutive days and for no more than 18 days from baseline to visit 4.
• This type of analgesics should not be used for more than 2 days a week prior to Baseline and a week prior to visit 4, when the exploratory outcome is assessed (cytokine release assay).
• If taking OTC pain medications daily agrees to continue its daily use at the same dosage throughout the study.
• If a participant is taking an over-the-counter medication daily for management of other type of pain or for prophylaxis of myocardial infarction or stroke, the participant will be encouraged to continue the same usage of that medication throughout the study.
• Agrees to not start any new prescription medication for the management of pain throughout the study

You may not qualify if:

• Participants with a history of congestive heart failure, rheumatoid arthritis or uncontrolled diabetes.
• Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial
• Participants with high blood pressure, history of abnormal electrocardiograms, history of heart conductance defects, malignant disease, chronic constipation, IBSc or any other severe acute or chronic medical or psychiatric condition or laboratory finding that may increase the risk associated with trial participation with Erenumab
• Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.
• History of facial trauma or orofacial or orthognathic surgery within the previous 6 months
• Patients with dental pain
• Patients with trigeminal neuralgia or other neuropathic pain in the craniofacial area
• Patients with degenerative joint disease in the TMJs, rheumatoid arthritis or any systemic arthritis
• Patients with chronic migraine with and w/o aura following the ICHD-3 criteria treated or not treated with medication
• Without excluding headache attributed to TMD
• Participants currently taking or have previously taken Erenumab or other CGRP monoclonal antibody (mAmb) or currently taking a CGRP-Receptor antagonist (gepants) for migraine prevention. CGRP-Receptor antagonist (gepants) for acute use for migraine are allowed.
• Patients with hypersensitivity to Erenumab
• Patients who have received the Botox injection protocol in the masseters and/or Migraine protocol within 3 months prior screening and baseline visit.
• Used injections for management of TMD (trigger point injections, steroid injections) within 2 weeks prior to the Screening and Baseline Visit
• Has commenced a new daily prescription medication for the management of pain within 30 days prior to the Screening and Baseline Visit

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Amgen: collaborator

Study Sites (1)

University of Maryland, School of Dentistry, Brotman Facial Pain Clinic

Baltimore, Maryland, 21201, United States

Location

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Craniomandibular Disorders; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Syndromes; Stomatognathic Diseases; Musculoskeletal Diseases

Interventions

erenumab

Condition Hierarchy (Ancestors)

Mandibular Diseases; Jaw Diseases; Joint Diseases; Muscular Diseases

Limitations and Caveats

Early termination due to low enrollment rate.

Results Point of Contact

• Title: Dr. Marcela Romero Reyes
• Organization: University of Maryland, School of Dentistry

mromero@umaryland.edu

4107067168

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Director Brotman Facial Pain Clinic

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 17, 2021
• Study Start: May 26, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Locations

US (1)