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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI) Pain Severity at 20 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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);
- •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.
研究组 & 干预措施
Arm A
Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments
干预措施: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments (Drug)
Arm B
Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments
干预措施: Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments (Drug)
结局指标
主要结局
Brief Pain Inventory (BPI) Pain Severity at 20 Weeks
时间窗: 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).
次要结局
- Brief Pain Inventory (BPI) Pain Interference at 20 Weeks(20 weeks)
- Average Daily Reported Pain Scores at 20 Weeks(20 weeks)
- % of Days Taking Medication for Pain at 20 Weeks(20 weeks)
- Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks(20 weeks)
- Jaw Function Limitation Scale (JFLS-8) at 20 Weeks(20 weeks)
- Patient Health Questionnaire (PHQ-4) at 20 Weeks(20 weeks)
- Somatic Symptoms Scale (SSS-8) at 20 Weeks(20 weeks)
- Brief Pain Inventory (BPI) Pain Severity at 24 Weeks(24 weeks.)
- Brief Pain Inventory (BPI) Pain Interference at 24 Weeks(24 weeks)
- Average Daily Reported Pain Scores at 24 Weeks(24 weeks)
- % of Days Taking Medication for Pain at 24 Weeks(24 weeks)
- Pain Improvement Using the Patient Global Impression of Change in Pain at 24 Weeks(24 weeks)
- Jaw Function Limitation Scale (JFLS-8) at 24 Weeks(24 weeks)
- Patient Health Questionnaire (PHQ-4) at 24 Weeks(24 weeks)
- Somatic Symptoms Scale (SSS-8) at 24 Weeks(24 weeks)
研究者
Domenick Zero
Professor, Department of Biomedical and Applied Sciences
Indiana University