Lamotrigine and Bupropion for Meniere's Disease

NCT05420350 | Unknown Phase 2 FDA Drug

• 1 other identifier: DBTC-003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Lamictal; Lamotrigine; Anticonvulsant; Meniere's Disease; Vertigo attack; Dizziness; Vestibular disorder; Wellbutrin; Bupropion

Outcome Measures

Primary Outcomes (2)

• Change in Ménière's vertigo attack frequency between groups

  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.

  Duration of lead-in to completion at week 30

• Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion

  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.

  Week 1 to Week 27

Secondary Outcomes (5)

• 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)

• Changes in patients' self-assessment of anxiety

  Baseline (Week 1) and Visit 8 (Week 27)

Other Outcomes (2)

• Change in patients' tinnitus from baseline to the end of treatment.

  Baseline (Week 1) and Visit 8 (Week 27)

• Change in patients' hearing loss from baseline to the end of treatment.

  Baseline (Week 1) and Visit 8 (Week 27)

Study Arms (2)

Lamotrigine and Bupropion

ACTIVE COMPARATOR

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.

Drug: Lamotrigine and Bupropion

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lamotrigine and Bupropion DRUG

Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day

Also known as: Lamictal, Lamictal ODT, Lamictal XR, Wellbutrin XL, Wellbutrin SR, Forfivo XL

Lamotrigine and Bupropion

Placebo DRUG

Oral pill matched with lamotrigine to be taken once or twice a day per study timeline Oral pill matched with bupropion to be taken twice a day

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dent Neuroscience Research Center: lead
• Cures Within Reach: collaborator
• Dent Family Foundation: collaborator

Study Sites (1)

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

MeSH Terms

Conditions

Meniere Disease; Vertigo; Dizziness; Vestibular Diseases

Interventions

Lamotrigine; Bupropion; 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; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Lixin Zhang, MD, PhD

  Dent Neurologic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxwell Kahn, JD

CONTACT

716-250-7002; mkahn@dentinstitute.com

Dawn Pytlik

CONTACT

716-250-3083; dpytlik@dentinstitute.com

Study Design

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

Model Details: Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 15, 2022
• Study Start: December 16, 2020
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (1)