Study of Lamotrigine to Treat Ménière's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Meniere's DiseaseMénière's VertigoVertigo, IntermittentVertigo, Aural
Interventions
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.

Trial Locations (1)

14226

Dent Neurologic Institute, Amherst

All Listed Sponsors
collaborator

University at Buffalo

OTHER

lead

Dent Neuroscience Research Center

OTHER

NCT02158585 - Study of Lamotrigine to Treat Ménière's Disease | Biotech Hunter | Biotech Hunter