A Randomized, Prospective, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Effectiveness of a Combination of Lamotrigine and Bupropion to Treat Meniere's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Ménière's vertigo attack frequency between groups
研究概览
简要总结
This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo to reduce definitive Meniere's vertigo attacks (DMVA) and dizziness in patients with Meniere's disease. Thirty four participants will be randomized to treatment or placebo groups. Each participant will take part in the trial for 34 weeks, or approximately 9 months.
详细描述
Participants begin with a 4 week lead-in after screening to determine the frequency and severity of vertigo they are experiencing. Participants continue to track their vertigo episodes throughout the study. At Visit 2, if eligible, participants begin the titration of lamotrigine or matching placebo. Participants are on the full dose of lamotrigine/placebo for 8 weeks, and then begin taking bupropion or matching placebo along with lamotrigine or matching placebo for 12 weeks. At Week 27, participants are tapered off lamotrigine/placebo and stop taking bupropion/placebo. Participants have an in-person visit approximately once a month over 9 months.
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)
盲法说明
Double-Blind
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
- •Adult participants, male and female aged 18 years or older
- •Diagnosis of definitive unilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- •Be experiencing active vertigo
- •Be in good general health as evidenced by medical history or, otherwise, have all other co-existing medical or psychiatric conditions stable, and or no greater than moderate in severity, as determined by the PI
- •Females of childbearing potential must use at least two forms of acceptable contraception, or remain abstinent; male participants must be willing to use condoms or other methods to ensure effective contraception with a partner
- •Be willing to comply with all study procedures and availability for the duration of the study
- •Be able to provide informed written consent, including agreement to privacy language either within the informed consent or in ancillary documents compliant with Health Insurance Portability and Accountability Act (HIPAA) before the initiation of any study-related procedures
排除标准
- •A diagnosis of bilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- •Be pregnant or lactating
- •Have active migraine-associated vertigo
- •Not be able to accurately identify and report episodes of vertigo
- •Diagnosis of any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Meniere's symptoms
- •Have a history of intolerance or sensitivity to lamotrigine
- •Previously failed the study drug
- •Received an intratympanic gentamicin injection(s) or endolymphatic sac surgery within in the last year
- •Have a family history of unexplained deafness
- •Have any current diseases or conditions that may be associated with an altered perception of processing stimuli
- •Have a history of substance abuse within the preceding 6 months prior to screening
- •Have non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Meniere's attacks by the participant
研究组 & 干预措施
Lamotrigine and Bupropion
Lamotrigine will be taken orally for a duration of 28 weeks, consisting of a six-week titration, 20-week study period, and two-week taper. Possible doses are 25mg one a day, 50mg once a day, 50mg twice a day, 75mg twice a day during titration; 125mg twice a day for the study period; and 125mg once a day during the two-week taper. Patients who discontinue at any point of the study will have a two-week taper of lamotrigine.
Bupropion will be taken orally for the duration of 20 week at the dosage of 100mg twice a day.
干预措施: Lamotrigine and Bupropion (Drug)
Placebo
The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Ménière's vertigo attack frequency between groups
时间窗: Duration of lead-in to completion at week 30
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of titration, and treatment compared to the 4-week lead-in phase. Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
时间窗: Week 1 to Week 27
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of treatment of lamotrigine alone and treatment of bupropion and lamotrigine.Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
次要结局
- Changes in patients' self-assessment of anxiety(Baseline (Week 1) and Visit 8 (Week 27))
- Changes in patients' self-assessment of dizziness(Baseline (Week 1) and Visit 8 (Week 27))
- Changes in patients' self-assessment of overall affect of symptoms(Baseline (Week 1) and Visit 8 (Week 27))
- Changes in patients' self-assessment of symptom impact on daily life function(Baseline (Week 1) and Visit 8 (Week 27))
- Changes in patients' self-assessment of depression(Baseline (Week 1) and Visit 8 (Week 27))
研究者
Lixin Zhang
Medical Director of the Dizziness and Balance Center
Dent Neuroscience Research Center