Back to resultsStudy of Lamotrigine to Treat Ménière's Disease
Primary Purpose
Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Lamotrigine, Lamictal, Anticonvulsant, Ménière's disease, Vertigo attack, Dizziness, Vestibular disorder
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
Sites / Locations
- Dent Neurologic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Lamotrigine
Arm Description
The placebo will match the lamotrigine dosage, frequency and duration.
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.
Outcomes
Primary Outcome Measures
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Measured with a daily questionnaire
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
Measured with daily questionnaire
Secondary Outcome Measures
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups
Measured with a daily questionnaire.
Improvement in Pure Tone Average in the Affected Ear
Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)
Improvement in Symptoms Severity
Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician
DHI Scores
Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.
Full Information
NCT ID
NCT02158585
First Posted
June 2, 2014
Last Updated
May 26, 2022
Sponsor
Dent Neuroscience Research Center
Collaborators
University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT02158585
Brief Title
Study of Lamotrigine to Treat Ménière's Disease
Official Title
Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dent Neuroscience Research Center
Collaborators
University at Buffalo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent, Vertigo, Aural
Keywords
Lamotrigine, Lamictal, Anticonvulsant, Ménière's disease, Vertigo attack, Dizziness, Vestibular disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will match the lamotrigine dosage, frequency and duration.
Arm Title
Lamotrigine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
Lamictal, 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, U3H27498KS
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
microcrystalline cellulose
Intervention Description
The placebo will match the lamotrigine dosage, frequency and duration.
Primary Outcome Measure Information:
Title
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Description
Measured with a daily questionnaire
Time Frame
Duration of 12-week pre-treatment and 12-week study period (treatment)
Title
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
Description
Measured with daily questionnaire
Time Frame
Duration of 12-week pre-treatment and 12-week study period (treatment)
Secondary Outcome Measure Information:
Title
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups
Description
Measured with a daily questionnaire.
Time Frame
Duration of Week 16 to 18
Title
Improvement in Pure Tone Average in the Affected Ear
Description
Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)
Time Frame
Prior to randomization and at completion of 12-week study period
Title
Improvement in Symptoms Severity
Description
Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician
Time Frame
12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
Title
DHI Scores
Description
Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.
Time Frame
Baseline (Week 1) and end of study (Week 18)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Zhang, MD, PhD
Organizational Affiliation
Dent Neurologic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
12. IPD Sharing Statement
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Study of Lamotrigine to Treat Ménière's Disease
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