Comparison · NCT02158585-cb1a4569
Lamotrigine vs Placebo: Improvement in Symptoms Severity
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Lamotrigine vs Placebo: Improvement in Symptoms Severity. Trial comparisons, record NCT02158585-cb1a4569. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02158585-cb1a4569
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.857 | 0.487 | 0.974 | wilson | |
| Risk in group 2 | 0.375 | 0.137 | 0.694 | wilson | |
| Risk difference, group 1 minus group 2 | 0.482 | -0.00676 | 0.748 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.29 | 0.889 | 5.88 | log | |
| Odds ratio, group 1 over group 2 | 10 | 0.777 | 129 | log | |
| Number needed to treat, for one more participant with the outcome on Lamotrigine than on Placebo | 2.07 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 6 | 7 | OG001 |
| Group 2 | Placebo | The placebo will match the lamotrigine dosage, frequency and duration. | 3 | 8 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- 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)
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study of Lamotrigine to Treat Ménière's Disease
- NCT number
- NCT02158585
- Phases
- PHASE2
- Conditions
- Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent, Vertigo, Aural
- Interventions
- Lamotrigine, Placebo
- Lead sponsor
- Dent Neuroscience Research Center
- Results first posted
- 2022-06-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02158585?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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