Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug
Intervention description(s): 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 at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Other intervention name(s): Aimovig®; Placebo
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment