NCT03578354撤回2 期
Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Dizziness Handicap Score
研究概览
简要总结
This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.
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
- •Severe vestibular migraine (VM)
排除标准
- •Neurologic or otologic disease other than VM
- •Psychiatric illness requiring medication
- •Medical illness including cancer, coronary artery or cerebrovascular disease
- •Known allergy to one of the test medications
- •Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures
- •Taking migraine prophylactic medication or vestibular suppressants.
- •Pregnant or breast feeding women
研究组 & 干预措施
4-AP
Experimental
15 mg 4-aminopyridine twice daily
干预措施: 4-aminopyridine (Drug)
Atenolol
Experimental
25 mg atenolol twice daily
干预措施: Atenolol (Drug)
Placebo
Placebo Comparator
Masked placebo twice daily
干预措施: Placebo (Other)
结局指标
主要结局
Change in Dizziness Handicap Score
时间窗: 14 weeks
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
次要结局
- Change in number of dizziness episodes(14 weeks)
- Change in motion sickness susceptibility(14 weeks)
- Change in roll tilt perceptual threshold(14 weeks)
- Change in vestibulo-ocular reflex (VOR) time constant(14 weeks)
- Change in Headache Impact Test (HIT) score(14 weeks)
- Change in quality of life score(14 weeks)
- Change in number of migraine episodes(14 weeks)
研究者
Richard Lewis
Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory
Massachusetts Eye and Ear Infirmary
研究点 (1)
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