Trial · NCT02158585
Study of Lamotrigine to Treat Ménière's Disease
NCT02158585, Phase 2, Completed, Dent Neuroscience Research Center; results first posted 2022-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lamotrigine to Treat Ménière's Disease. Trials, record NCT02158585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02158585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lamotrigine to Treat Ménière's Disease
- NCT number
- NCT02158585
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Dent Neuroscience Research Center
- Conditions
- Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent, Vertigo, Aural
- Interventions
- Lamotrigine, Placebo
- First posted
- 2014-06-09
- Last updated
- 2022-06-22
- Results first posted
- 2022-06-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Duration of 12-week pre-treatment and 12-week study period (treatment) | Measured with a daily questionnaire |
| Primary | Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group | Duration of 12-week pre-treatment and 12-week study period (treatment) | Measured with daily questionnaire |
| Secondary | Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups | Duration of Week 16 to 18 | Measured with a daily questionnaire. |
| Secondary | Improvement in Pure Tone Average in the Affected Ear | 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) |
| Secondary | Improvement in Symptoms Severity | 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 |
| Secondary | DHI Scores | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Duration of 12-week pre-treatment and 12-week study period (treatment) | Average Total Number of Vertigo Attacks | MEAN | |
| PRIMARY | Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group | Duration of 12-week pre-treatment and 12-week study period (treatment) | Average Total Number of Vertigo Attacks | MEAN | |
| SECONDARY | Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups | Duration of Week 16 to 18 | Average Total Number of Vertigo Attacks | MEAN | |
| SECONDARY | Improvement in Pure Tone Average in the Affected Ear | Prior to randomization and at completion of 12-week study period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Improvement in Symptoms Severity | 12-week pre-treatment period; 6 week titration; 12-week study period (treatment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | DHI Scores | Baseline (Week 1) and end of study (Week 18) | score on DHI | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Placebo | Pre-Treatment (Week -12 to -1) | 18.88 | Standard Deviation 6.27 | Average Total Number of Vertigo Attacks |
| Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Lamotrigine | Pre-Treatment (Week -12 to -1) | 18.00 | Standard Deviation 12.65 | Average Total Number of Vertigo Attacks |
| Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Placebo | Treatment (Week 7 to 18) | 13.50 | Standard Deviation 14.54 | Average Total Number of Vertigo Attacks |
| Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group | Lamotrigine | Treatment (Week 7 to 18) | 4.57 | Standard Deviation 4.96 | Average Total Number of Vertigo Attacks |
| Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group | Lamotrigine | Pre-treatment | 18.00 | Standard Deviation 12.65 | Average Total Number of Vertigo Attacks |
| Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group | Lamotrigine | Study Period | 4.57 | Standard Deviation 4.96 | Average Total Number of Vertigo Attacks |
| Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups | Placebo | 4.86 | Standard Deviation 4.02 | Average Total Number of Vertigo Attacks | |
| Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups | Lamotrigine | 0.29 | Standard Deviation 0.76 | Average Total Number of Vertigo Attacks | |
| Improvement in Pure Tone Average in the Affected Ear | Placebo | 3 | Participants | ||
| Improvement in Pure Tone Average in the Affected Ear | Lamotrigine | 5 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Lamotrigine | 7 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | COMPLETED | Lamotrigine | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Lamotrigine | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal problem | Gastrointestinal disorders | Placebo | 1 | 8 | 1 |
| other | Gastrointestinal problem | Gastrointestinal disorders | Lamotrigine | 0 | 7 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, all-cause mortality | Lamotrigine | 0 | 7 |
| Total, other adverse events | Placebo | 1 | 8 |
| Total, other adverse events | Lamotrigine | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Lamotrigine | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lamotrigine vs Placebo: Improvement in Pure Tone Average in the Affected Ear | Trial comparisons |
| Lamotrigine vs Placebo: Improvement in Symptoms Severity | Trial comparisons |
| Lamotrigine vs Placebo: deaths from any cause | Trial comparisons |
| Lamotrigine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02158585
GET https://conductscience.org/api/trials/v1/NCT02158585/registered