A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 126
- 试验地点
- 32
- 主要终点
- Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of Temporomandibular Disorders (TMD), which are medical conditions involving the temporomandibular joint (the joint connecting the jawbone to the skull) and surrounding muscles and tissues.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Subject has a minimum 3-month to a maximum 5-year history of temporomandibular disorder diagnosed by a healthcare provider.
- •At least one instance of pain ≥ 6 on a Numeric Rating Scale (NRS) (0-10) in the jaw and/or temple area on either side in the past 30 days prior to the Screening Visit.
- •Subject agrees to study-required restrictions of new pain medication, injection therapy, oral devices, occlusal splint therapy or any other pain management techniques during the course of the study.
- •Subject agrees to study-required birth control methods during the course of the study and female subjects must not be breastfeeding.
- •No clinically significant abnormality identified on the medical or laboratory evaluation.
排除标准
- •* Subject has an exclusionary headache, joint, pain, connective tissue, or developmental disorder.
- •Subject has an exclusionary history of trauma, surgery, or radiation treatment to the head and neck.
- •Body Mass Index ≥ 33kg/m
- •Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
- •Subjects taking/using excluded therapies.
- •Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
- •Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
- •Planned participation in any other investigational clinical trial while participating in this clinical trial.
研究组 & 干预措施
BHV3000 (rimegepant)
One dose of rimegepant 75 mg ODT
干预措施: Rimegepant (Drug)
Matching Placebo
One dose of matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2)
时间窗: Baseline (0 hours) to 2-hours post-dose
The SPID-2 was calculated by multiplying the pain intensity difference (PID) score at each post-dose timepoint by the duration (in hours) since the preceding timepoint, then summing the values over the 2 hours. Participants indicated pain using e-diary at each timepoint (0, 15, 30, 45-, 60-, 90- and 120-minutes post-dose) on an NRS score ranging from 0 (no pain) to 10 (worst imaginable pain). PID: calculated by finding the difference between the NRS score at each timepoint from the baseline NRS score (PID range is -6 \[best\] to 4 \[worst\]). Assuming a baseline pain intensity score of 6, possible score range of SPID-2 was: -12 (best) to 8 (worst). Lower SPID-2 score = more improvement from pain. SPID-2 Best is 2 hours\*-6 = -12 (assuming 0 pain intensity score \[pain-free\] for each timepoint) and 2) Worst is 2 hours\*4 = 8 (assuming 10 pain intensity score \[worst imaginable pain\] for each timepoint).
SPID From Baseline to 24-Hours Post-dose (SPID-24)
时间窗: Baseline (0 hours) to 24-hours post-dose
The SPID-24 was calculated by multiplying the PID score at each post-dose timepoint by the duration (in hours) since the preceding timepoint, then summing the values over the 24 hours. Participants indicated pain using e-diary at each timepoint (0, 15, 30, 45, 60, 90 and 120 minutes and 4-, 8-, and 24-hours post-dose) on an NRS score ranging from 0 (no pain) to 10 (worst imaginable pain). PID: calculated by finding the difference between the NRS score at each timepoint from the baseline NRS score (PID range is -6 \[best\] to 4 \[worst\]). Assuming a baseline pain intensity score of 6, possible score range of SPID-24 was: -144 (Best) to 96 (worst). Lower SPID-24 score = more improvement from pain. SPID-24 best and worst scores were calculated as: 1) Best is 24 hours\* -6 = -144 (assuming 0 pain intensity score for each timepoint) and 2) Worst is 24 hours\*4 = 96 (assuming 10 pain intensity score for each timepoint).
次要结局
- Time to Onset of Meaningful Pain Relief(Baseline (0 hours) up to 24 hours post-dose)
- Time to Onset of Initial Pain Relief(Baseline (0 hour) to 24 hours post-dose)
- Change From Baseline in NRS Score at 2-Hours Post-Dose(Baseline (0 hours), 2-hours post-dose)
- Percentage of Participants Who Experienced Pain Freedom at 2-Hours Post-Dose(Baseline (0 hour) to 2-hours post-dose)
- Percentage of Participants Using Rescue Medication Within 24 Hours Post-Dose(Through 24 hours post-dose)