Comparison · NCT01430754-9b216d6e
Tasimelteon vs Placebo: Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Tasimelteon vs Placebo: Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD. Trial comparisons, record NCT01430754-9b216d6e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01430754-9b216d6e
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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 | 0.9 | 0.596 | 0.982 | wilson | |
| Risk in group 2 | 0.2 | 0.0567 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | 0.7 | 0.266 | 0.865 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.5 | 1.28 | 15.8 | log | |
| Odds ratio, group 1 over group 2 | 36 | 2.72 | 476 | log | |
| Number needed to treat, for one more participant with the outcome on Tasimelteon than on Placebo | 1.43 | 1.16 | 3.76 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tasimelteon | 20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily | 9 | 10 | OG000 |
| Group 2 | Placebo | Placebo capsules~Placebo: Placebo capsules, daily | 2 | 10 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.
- Description
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI \>24.0.
- Time frame
- Approximately 12 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
- NCT number
- NCT01430754
- Phases
- PHASE3
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Interventions
- tasimelteon, Placebo
- Lead sponsor
- Vanda Pharmaceuticals
- Results first posted
- 2014-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01430754?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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