Trial Outcomes & Findings for Study of Lamotrigine to Treat Ménière's Disease (NCT NCT02158585)

NCT ID: NCT02158585

Last Updated: 2022-06-22

Results Overview

Measured with a daily questionnaire

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Duration of 12-week pre-treatment and 12-week study period (treatment)
• Results posted on: 2022-06-22

Participant Flow

12-week pre-treatment period

Participant milestones

Measure	Placebo The placebo will match the lamotrigine dosage, frequency and duration.	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.
Overall Study STARTED	8	7
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Lamotrigine to Treat Ménière's Disease

Baseline characteristics by cohort

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 13.8 • n=5 Participants	55.1 years STANDARD_DEVIATION 12.9 • n=7 Participants	57.6 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

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

Measured with a daily questionnaire

Outcome measures

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group Pre-Treatment (Week -12 to -1)	18.88 Average Total Number of Vertigo Attacks Standard Deviation 6.27	18.00 Average Total Number of Vertigo Attacks Standard Deviation 12.65
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group Treatment (Week 7 to 18)	13.50 Average Total Number of Vertigo Attacks Standard Deviation 14.54	4.57 Average Total Number of Vertigo Attacks Standard Deviation 4.96

PRIMARY outcome

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

Measured with daily questionnaire

Outcome measures

Measure	Placebo n=7 Participants The placebo will match the lamotrigine dosage, frequency and duration.	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.
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group Pre-treatment	18.00 Average Total Number of Vertigo Attacks Standard Deviation 12.65	—
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group Study Period	4.57 Average Total Number of Vertigo Attacks Standard Deviation 4.96	—

SECONDARY outcome

Timeframe: Duration of Week 16 to 18

Measured with a daily questionnaire.

Outcome measures

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups	4.86 Average Total Number of Vertigo Attacks Standard Deviation 4.02	0.29 Average Total Number of Vertigo Attacks Standard Deviation 0.76

SECONDARY outcome

Timeframe: Prior to randomization and at completion of 12-week study period

Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)

Outcome measures

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.
Improvement in Pure Tone Average in the Affected Ear	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 12-week pre-treatment period; 6 week titration; 12-week study period (treatment)

Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician

Outcome measures

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.
Improvement in Symptoms Severity	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Week 1) and end of study (Week 18)

Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.

Outcome measures

Measure	Placebo n=8 Participants The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 Participants 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.
DHI Scores Baseline	57.50 score on DHI Standard Deviation 17.26	37.14 score on DHI Standard Deviation 12.05
DHI Scores End of Study	49.43 score on DHI Standard Deviation 25.73	38.29 score on DHI Standard Deviation 19.44

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Lamotrigine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=8 participants at risk The placebo will match the lamotrigine dosage, frequency and duration.	Lamotrigine n=7 participants at risk 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, 100 mg twice a day and 150mg twice a day during titration; 150mg twice a day or 100mg twice a day for the 12-week study period; 150mg once a day, or 100mg once a day for Week 1 of the taper; and 75mg once a day, or 50mg 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.
Gastrointestinal disorders Gastrointestinal problem	12.5% 1/8 • Number of events 1 • 18 weeks Patients reported whether or not there were any changes in health during every study visit. They were also encouraged to call the clinic if there were any changes.	0.00% 0/7 • 18 weeks Patients reported whether or not there were any changes in health during every study visit. They were also encouraged to call the clinic if there were any changes.

Additional Information

Dr. Jennifer Cox

DENT Neurosciences Research Center

Phone: 716-250-7002

Email: jcox@dentinstitute.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place