Meniere's DiseasePhase 2NCT02158585
Study of Lamotrigine to Treat Ménière's Disease
A Phase 2 study testing Lamotrigine in people with Meniere's Disease and Ménière's Vertigo, run by Dent Neuroscience Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
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.
- Being tested
- Lamotrigine, Placebo
- Keywords
- Lamotrigine, Lamictal, Anticonvulsant, Ménière's disease, Vertigo attack, Dizziness, Vestibular disorder
- Medical subject headings
- Meniere Disease, Vertigo, Dizziness, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal, 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, U3H27498KS
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.
PlaceboDrug
Also called microcrystalline cellulose
The placebo will match the lamotrigine dosage, frequency and duration.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo will match the lamotrigine dosage, frequency and duration. Receives: 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. Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Measured with a daily questionnaire
Measured: 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
Measured: 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
Measured with a daily questionnaire.
Measured: Duration of Week 16 to 18
Improvement in Pure Tone Average in the Affected Ear
Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)
Measured: Prior to randomization and at completion of 12-week study period
Improvement in Symptoms Severity
Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician
Measured: 12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
DHI Scores
Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.
Measured: Baseline (Week 1) and end of study (Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dent Neuroscience Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Principal investigator, Lixin Zhang, Dent Neuroscience Research Center
- Investigators
- Lixin Zhang, MD, PhD, Principal investigator, Dent Neurologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158585
- Sponsor's protocol ID
- Zhang-001
- Status last verified
- May 2022
- First submitted
- 2 Jun 2014
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02158585
- Acronym / sponsor ID
- Zhang-001
- Keywords
- Lamotrigine, Lamictal, Anticonvulsant, Ménière's disease, Vertigo attack, Dizziness, Vestibular disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dent Neuroscience Research CenterUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Jun 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Posted 22 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will match the lamotrigine dosage, frequency and duration. |
| Lamotrigine | Active comparator | Drug: LamotrigineLamotrigine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LamotrigineAlso: Lamictal, 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, U3H27498KSLamotrigine 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 | Lamotrigine |
| PlaceboAlso: microcrystalline celluloseThe placebo will match the lamotrigine dosage, frequency and duration. | Drug | Placebo |
Primary outcome
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Time frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with a daily questionnaire
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
Time frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with daily questionnaire
4 secondary outcomes
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups
Time frame: Duration of Week 16 to 18
Improvement in Pure Tone Average in the Affected Ear
Time frame: Prior to randomization and at completion of 12-week study period
Improvement in Symptoms Severity
Time frame: 12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
DHI Scores
Time frame: Baseline (Week 1) and end of study (Week 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meniere's Disease
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Zhang, MD, PhD principal investigator
Dent Neurologic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamotrigine in people with Meniere's Disease and Ménière's Vertigo, run by Dent Neuroscience Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group (time frame: Duration of 12-week pre-treatment and 12-week study period (treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.