Study of Lamotrigine to Treat Ménière's Disease | NCT02158585

NCT02158585

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University at Buffalo	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups	Measured with a daily questionnaire.	Duration of Week 16 to 18
Improvement in Pure Tone Average in the Affected Ear

Eligibility Module

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

Name	Affiliation	Role
Lixin Zhang, MD, PhD	Dent Neurologic Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dent Neurologic Institute		Amherst	New York	14226	United States

Arm/Group Information

ID	Title	Description
FG000	Placebo	The placebo will match the lamotrigine dosage, frequency and duration.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	The placebo will match the lamotrigine dosage, frequency and duration.
BG001	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Measured with a daily questionnaire

Posted

Mean

Standard Deviation

Average Total Number of Vertigo Attacks

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

ID	Title	Description
OG000	Placebo	The placebo will match the lamotrigine dosage, frequency and duration.
OG001	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	The placebo will match the lamotrigine dosage, frequency and duration.

ID	Term
D008575	Meniere Disease
D014717	Vertigo
D004244	Dizziness
D015837	Vestibular Diseases

ID	Term
D018159	Endolymphatic Hydrops
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D000077213	Lamotrigine
C109691	microcrystalline cellulose

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds