NCT07279623招募中不适用
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine - A Prospective, Randomized, Open Label, Delayed-Start Study to Evaluate the Safety and Performance of the Walther System
Abilion Medical Systems AB2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年10月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Monthly Migraine Days
研究概览
简要总结
This is a prospective, randomized, open-label, delayed-start clinical investigation evaluating the safety and efficacy of the Walther System, a Class IIa investigational medical device delivering intra-nasal mechanical stimulation (INMEST), as a preventative treatment for migraine. A total of 110 adults (18-65 years) with a history of migraine will be randomized 1:1 into two groups: Group A (early treatment) and Group B (delayed treatment). The study includes baseline assessments, in-clinic device training, and home-based self-administered treatments every second day for six weeks. The primary outcome is the change in monthly migraine days during the primary treatment comparison period. Secondary outcomes include headache days, migraine intensity, duration, rescue medication use, patient-reported outcomes, device compliance, and safety. The study will be conducted at one site in Sweden.
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
- None
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
- •Age 18-65 years at the time of screening.
- •The study subject must have a clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-3), indicated by medical record shown by the subject.
- •Onset of migraine headache occurred before age
- •History of migraines for at least 1 year before screening.
- •The study subject reports at least 8 monthly migraine days during the screening period.
- •If subject is on a prophylactic migraine medication regimen:
- •Reports stable medication regimen during the three months prior to screening.
- •Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up.
- •The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
- •Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
- •Anticipated compliance with prescribed treatment and follow-up.
排除标准
- •Subject unable to distinguish between migraine headaches and other headache types.
- •Recently (12 months prior screening) undergone nasal or sinus surgery.
- •Any severe diseases for which, in the opinion of the Investigator, participation would not be in the best interest of the subject or that can interfere with the performance, evaluation, and outcome of the clinical evaluation.
- •Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
- •Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
- •The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
- •The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
结局指标
主要结局
Change in Monthly Migraine Days
时间窗: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)
Between-group comparison of the difference in mean change in monthly migraine days from the baseline assessment period (weeks 1-4) to Group A) Treatment performance period (weeks 7-10) and Group B) No treatment reference period (weeks 7-10).
次要结局
- Mean change in PROMIS-PI SF-6b(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in monthly headache days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in duration of migraine attacks(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Number of participants with ≥30% and ≥50% reduction in monthly migraine days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in Patient Global Impression of Severity (PGI-S)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in monthly migraine days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in migraine intensity (6-point severity scale)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Proportion of migraine attacks requiring rescue medication(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
- Mean change in monthly headache days(Weeks 7-10)
- Mean change in duration of migraine attacks(Weeks 7-10)
- Number of participants with ≥30% and ≥50% reduction in monthly migraine days(Weeks 7-10)
- Mean change in PROMIS-PI SF-6b(Weeks 7-10)
- Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)(Weeks 7-10)
- Mean change in Patient Global Impression of Severity (PGI-S)(Weeks 7-10)
- Mean change in migraine intensity(Weeks 7-10)
- Proportion of attacks requiring rescue medication(Weeks 7-10)
- Proportion of prescribed treatments completed(Throughout the 6-week treatment period)
- Adverse Events / Serious Adverse Events / Device Effects(Through study completion (14 or 20 weeks, depending on treatment group))
- Device Deficiencies(Throughout the 6-week treatment period)
研究者
研究点 (2)
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