A Phase 2, Double-blind, Randomized, Multicenter, Placebo-controlled, Three Arm Parallel Study to Evaluate the Efficacy and Safety of TNX-1900 (Intranasal Oxytocin) in Patients With Chronic Migraine (PREVENTION Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 24
- 主要终点
- Mean Change in the Number of Monthly Migraine Headache Days
研究概览
简要总结
This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 65 years, inclusive, at the time of Visit
- •History of migraine with or without aura for at least 1 year and onset at < 50 years of age. Patient must also have a history of chronic migraine > 3 months prior to Visit 1 as defined by IHS ICHD-3
- •Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for 90 days prior to Screening and during the study. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Note: Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study.
排除标准
- •History of cluster headache.
- •Presence of headaches more than 26 days a month on average for the 6 months prior to Screening.
- •Failed to benefit from an adequate dose and duration, in the investigator's judgment (eg, one month of β-blocker), of 3 or more migraine preventive medications.
- •Use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to Visit 1 and during the study.
- •Use of over-the-counter (OTC) nasal products (ie, saline spray, Neti-Pot, Naväge® etc.) during the study.
- •Any use of intranasal corticosteroid medications or conditions in which use of intranasal corticosteroids may be indicated during the study, eg, unstable allergic rhinitis that has previously required intranasal corticosteroids. Intranasal corticosteroid use is not allowed within 28 days of Baseline/Randomization/Visit 2 and during the treatment phase or follow-up period of the study.
- •Patients who recently discontinued treatment with an anti-calcitonin-gene-related peptide (CGRP) or participated in anti-CGRP clinical study must be at least 4 months from the last drug administration prior to Visit 1.
研究组 & 干预措施
TNX-1900 High Dose
30 IU oxytocin taken intranasally twice daily.
干预措施: TNX-1900 (Drug)
TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
干预措施: TNX-1900 (Drug)
TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
干预措施: Placebo Nasal Spray (Drug)
Placebo
Placebo taken intranasally twice daily.
干预措施: Placebo Nasal Spray (Drug)
结局指标
主要结局
Mean Change in the Number of Monthly Migraine Headache Days
时间窗: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.
次要结局
- Mean Change in the Number of Moderate or Severe Headache Days(Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12))
- Mean Change in the Number of Days Using Rescue Medication(Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12))
- Patient Global Impression of Change (PGIC)(Visit 5 (Week 12))
- Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days(Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12))
- Mean Change in the Number of Migraine Headache Days(Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period)
- Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire(Visit 2 (Day 1) and Visit 5 (Week 12))