NCT02158585

Study of Lamotrigine to Treat Ménière's Disease

Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dent Neuroscience Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Meniere's Disease
• Ménière's Vertigo
• Vertigo, Intermittent
• Vertigo, Aural

Interventions

Type	Name	Description
DRUG	Lamotrigine	Lamotrigine will be taken orally on a daily basis for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses for patients 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. Each increase in dose will be maintained for two weeks before deciding to further increase or decrease based on tolerability. Patients who discontinue 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.
DRUG	Placebo	The placebo will match the lamotrigine dosage, frequency and duration.

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-06-09
• Last updated: 2022-06-22
• Results posted: 2022-06-22

Locations

1 site across 1 country: United States