AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 3-ARM, STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 1,280
- 主要终点
- Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase.
研究概览
简要总结
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:
- freedom from pain, 2 hours after taking the medicine for the first migraine attack.
- consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.
This study is seeking participants who:
- are 18 years of age or older.
- have migraine attacks present for at least 1 year with age onset before 50 years old.
- have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
- have 3 to 8 attacks per month but less than15 headache days per month.
If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.
After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.
The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.
The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.
During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:
- Pain
- Pain symptoms
- How the participants are feeling
- General well-being
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, Care Provider, Investigator)
盲法说明
This is a double-blind study where neither the investigator nor participant will know which arm the participant is assigned (active/placebo).
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
- •Participants aged 18 years or older.
- •Participants with minimum 1 year history of migraine with age onset before 50 years of age.
排除标准
- •History of retinal migraine, basilar migraine or hemiplegic migraine.
- •History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
- •Major depressive disorder or anxiety disorder.
- •Acute or chronic pain syndromes.
- •Conditions that may affect the administration or absorption of the nasal product.
- •History of alcohol abuse and/or illicit drug.
- •Other social, medical, or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s)
- •History of use of ergotamine medications or triptans on greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months. Or history of non-narcotic analgesic intake on greater than/equal to 15 days per month for greater than/equal to 3 months for other pain indications.
- •Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days prior to Baseline Visit.
- •Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
- •Previous participation in any zavegepant study within the last 2 years.
- •ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
- •Class 2 or Class 3 obesity, defined as body mass index >35 kg/m
- •Estimated Globular Filtration Rate <30 mL/min/1.73 m
- •Total bilirubin ≥1.5 × upper limit of normal.
- •Liver transaminases ≥2.0 × upper limit of normal .
- •Neutrophil count ≤1000/μL (or equivalent).
研究组 & 干预措施
Zavegepant 10 mg
This is the active arm where the participant will receive 4 doses of the zavegepant 10mg intranasal
干预措施: Zavegepant 10 mg (Combination Product)
Placebo - Control 1
This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant.
干预措施: Placebo - Control 1 (Combination Product)
Placebo - Control 2
This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant.
干预措施: Placebo - Control 2 (Combination Product)
结局指标
主要结局
Comparing efficacy of zavegepant with placebo in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the Double-Blind Treatment (DBT) Phase.
时间窗: 2 hours post-dose
Pain levels will be assessed on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) using an electronic handheld device. Pain freedom is measured as a pain level of none at 2 hours post-dose.
Consistency of efficacy of zavegepant across multiple attacks in the acute treatment of migraine as measured by pain freedom at 2-hours post dose during the DBT Phase.
时间窗: 2 hours post-dose
Freedom from pain response, defined as pain freedom at 2 hours post-dose in ≥2 of 3 qualifying migraine attacks of moderate to severe in intensity.
次要结局
- Percentage of participants with sustained pain freedom from 2 to 48 hours post-dose(2 to 48 hours post-dose)
- Percentage of participants with freedom from Most Bothersome Symptoms (MBS) at 2 hours post-dose(2 hours post-dose)
- Percentage of participants with grade 3 or 4 laboratory test abnormalities(Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.)
- Percentage of participants with consistency of pain relief for at least 2 of 3 qualifying attacks at 2 hours post-dose(2 hours post-dose)
- Percentage of participants with pain relief at 2 hours post-dose(2 hours post-dose)
- Percentage of participants with serious adverse events (SAEs)(Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.)
- Percentage of participants with local irritation AEs(Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.)
- Percentage of participants with pain relief at 15 minutes post-dose(15 minutes)
- Percentage of participants with return to normal function at 30 minutes post-dose(30 minutes post-dose)
- Percentage of participants with return to normal function at 2 hours post-dose(2 hours post-dose)
- Percentage of participants in the triptan resistant/refractory (TRR) group with pain freedom at the 2 hours post-dose(2 hours post-dose)
- Percentage of participants with adverse events (AEs) of moderate or severe intensity(Duration of study (up to 26 weeks from signing of the inform consent to the safety follow-up period.)