Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
研究概览
简要总结
This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo or lamotrigine.
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
- •Male and female participants aged 18 years or older
- •Diagnosed with unilateral definite Ménière's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT
- •Active vertigo: at least two Ménière's vertigo attacks (defined as lasting 20 minutes or longer and associated with tinnitus, ear fullness, or low frequency hearing loss and nausea/vomiting) every four weeks during the eight-week qualification period and at least two more Ménière's vertigo attacks during the lead-in phase prior to randomization
- •Documented unilateral lower frequency hearing loss defined as the four-tone average (arithmetic mean rounded to the nearest whole number) of the pure-tone thresholds at 0.25, 0.5, 1 and 2 kilohertz (kHz) more than or equal to 25 decibels (dB) of the worse audiogram during the six months before screening
- •Have tried diuretics for at least one month and discontinued treatment due to continued vertigo attacks
- •All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
- •Willing to avoid pregnancy during the entirety of the study (abstinence or two forms of acceptable birth control, such as condoms and oral contraceptives)
排除标准
- •Bilateral Ménière's disease
- •Current or past history of migraine
- •Any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Ménière's symptoms
- •Previous intolerance or sensitivity to lamotrigine
- •On any prohibited medication within four weeks prior to the study
- •History of tympanostomy tubes with evidence of perforation or lack of closure
- •IT gentamicin injections or endolymphatic sac surgery within the last year
- •History of or current immunodeficiency disease, nephrolithiasis, hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
- •Family history of unexplained deafness
- •Pregnant or breastfeeding
- •Current diseases or conditions that may be associated with an altered perception of processing stimuli
- •Current severe medical condition(s) that in the view of the investigator prohibits participation
- •Previously used the investigational drug
- •Current non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Ménière's attacks by the participant
研究组 & 干预措施
Placebo
The placebo will match the lamotrigine dosage, frequency and duration.
干预措施: Placebo (Drug)
Lamotrigine
Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Patients who withdraw at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
时间窗: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with a daily questionnaire
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
时间窗: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with daily questionnaire
次要结局
- Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups(Duration of Week 16 to 18)
- Improvement in Pure Tone Average in the Affected Ear(Prior to randomization and at completion of 12-week study period)
- Improvement in Symptoms Severity(12-week pre-treatment period; 6 week titration; 12-week study period (treatment))
- DHI Scores(Baseline (Week 1) and end of study (Week 18))
研究者
Lixin Zhang
Medical Director of the Dizziness and Balance Center
Dent Neuroscience Research Center