Study of Lamotrigine to Treat Ménière's Disease

NCT ID: NCT02158585

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

The placebo will match the lamotrigine dosage, frequency and duration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo will match the lamotrigine dosage, frequency and duration.

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.

Group Type: ACTIVE_COMPARATOR

Lamotrigine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

The placebo will match the lamotrigine dosage, frequency and duration.

Intervention Type: DRUG

Other Intervention Names

Lamictal; 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine; U3H27498KS; microcrystalline cellulose

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: collaborator

Dent Neuroscience Research Center

OTHER

Sponsor Role: lead

Responsible Party

Lixin Zhang

Medical Director of the Dizziness and Balance Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dent Neurologic Institute

Locations

Dent Neurologic Institute

Amherst, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Zhang-001

Identifier Type: -

Identifier Source: org_study_id