Study of Lamotrigine to Treat Ménière's Disease

NCT02158585 | Completed Phase 2 Results DMC

• 1 other identifier: Zhang-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Lamotrigine; Lamictal; Anticonvulsant; Ménière's disease; Vertigo attack; Dizziness; Vestibular disorder

Outcome Measures

Primary Outcomes (2)

• Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group

  Measured with a daily questionnaire

  Duration of 12-week pre-treatment and 12-week study period (treatment)

• Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group

  Measured with daily questionnaire

  Duration of 12-week pre-treatment and 12-week study period (treatment)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Lamotrigine

ACTIVE COMPARATOR

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.

Drug: Lamotrigine

Interventions

Lamotrigine 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.

Also known as: Lamictal, 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, U3H27498KS

Lamotrigine

Placebo DRUG

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

Also known as: microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dent Neuroscience Research Center: lead
• University at Buffalo: collaborator

Study Sites (1)

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Meniere Disease; Vertigo; Dizziness; Vestibular Diseases

Interventions

Lamotrigine; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jennifer Cox
• Organization: DENT Neurosciences Research Center

jcox@dentinstitute.com

716-250-7002

Study Officials

• Lixin Zhang, MD, PhD

  Dent Neurologic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Dizziness and Balance Center

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 22, 2022
• Results First Posted: June 22, 2022

Record last verified: 2022-05

Locations

US (1)