Trial · NCT01163032
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
NCT01163032, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2014-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder. Trials, record NCT01163032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01163032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
- NCT number
- NCT01163032
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Interventions
- tasimelteon, Placebo
- First posted
- 2010-07-15
- Last updated
- 2014-10-16
- Results first posted
- 2014-10-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Entrained as Assessed by Urinary aMT6 | 1 month | 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 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0. |
| Primary | Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS | 6 months | Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below). LQ-nTST: \>45 minutes increase in average nighttime sleep duration; UQ-dTSD: \>45 minutes decrease in average daytime sleep duration; MoST: \>30 minutes increase and a standard deviation \<2 hours during double-masked phase (6 months); CGI-C: \<2.0 from the average of D112 and Day 183 compared to baseline For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203. |
| Secondary | Proportion of Patients Entrained as Assessed by Urinary Cortisol | 1 month | Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0. |
| Secondary | Average Clinical Global Impression of Change (CGI-C) | Day 112 and 183 | CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement. |
| Secondary | Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes) | 6 months | The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder. |
| Secondary | Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST) | 6 months | LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (\~ 6 weeks). The higher number indicates improvement. |
| Secondary | Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD) | 6 months | UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (\~ 6 weeks). Lower number indicates improvement. |
| Secondary | Average Midpoint of Sleep (MoST) | 6 months | Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average. |
| Secondary | Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only) | 6 months | Adverse events were recorded in the source documents from the time of the patient's informed consent signature until the end of the patient's study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment. |
| Other | Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS | 6 months | Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below). LQ-nTST: \>45 minutes increase in average nighttime sleep duration; UQ-dTSD: \>45 minutes decrease in average daytime sleep duration; MoST: \>30 minutes increase and a standard deviation \<2 hours during double-masked phase (6 months); CGI-C: \<2.0 from the average of D112 and Day 183 compared to baseline For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Entrained as Assessed by Urinary aMT6 | 1 month | Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization. | percentage of patients | NUMBER |
| PRIMARY | Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS) | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Entrained as Assessed by Urinary Cortisol | 1 month | Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization. | percentage of patients | NUMBER |
| SECONDARY | Average Clinical Global Impression of Change (CGI-C) | Day 112 and 183 | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | score | MEAN |
| SECONDARY | Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes) | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | percentage of patients | NUMBER |
| SECONDARY | Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST) | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | minutes | MEAN |
| SECONDARY | Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD) | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | minutes | MEAN |
| SECONDARY | Average Midpoint of Sleep (MoST) | 6 months | Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization) | minutes | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Entrained as Assessed by Urinary aMT6 | Tasimelteon (Randomized) | 20 | percentage of patients | ||
| Proportion of Patients Entrained as Assessed by Urinary aMT6 | Placebo (Randomized) | 2.6 | percentage of patients | ||
| Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS | Tasimelteon (Randomized) | 23.7 | percentage of patients | ||
| Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS | Placebo (Randomized) | 0 | percentage of patients | ||
| Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS | Tasimelteon (Randomized) | 28.9 | percentage of patients | ||
| Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS | Placebo (Randomized) | 0 | percentage of patients | ||
| Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS) | Tasimelteon (Randomized) | 28.9 | percentage of patients | ||
| Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS) | Placebo (Randomized) | 2.9 | percentage of patients | ||
| Proportion of Patients Entrained as Assessed by Urinary Cortisol | Tasimelteon (Randomized) | 17.5 | percentage of patients | ||
| Proportion of Patients Entrained as Assessed by Urinary Cortisol | Placebo (Randomized) | 2.6 | percentage of patients |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Phase | STARTED | Tasimelteon (Randomized) | 42 | |
| Randomization Phase | STARTED | Placebo (Randomized) | 42 | |
| Randomization Phase | STARTED | Open Label Tasimelteon | 0 | |
| Randomization Phase | COMPLETED | Tasimelteon (Randomized) | 32 | |
| Randomization Phase | COMPLETED | Placebo (Randomized) | 30 | |
| Randomization Phase | COMPLETED | Open Label Tasimelteon | 0 | |
| Randomization Phase | NOT COMPLETED | Tasimelteon (Randomized) | 10 | |
| Randomization Phase | NOT COMPLETED | Placebo (Randomized) | 12 | |
| Randomization Phase | NOT COMPLETED | Open Label Tasimelteon | 0 | |
| Open Label Extension Phase | STARTED | Tasimelteon (Randomized) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
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 | Nausea | Gastrointestinal disorders | Tasimelteon (Randomized) | 1 | 42 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo (Randomized) | 3 | 42 | 3 |
| other | Nausea | Gastrointestinal disorders | Open Label Tasimelteon | 0 | 54 | 0 |
| other | Nasopharyngitis | Infections and infestations | Tasimelteon (Randomized) | 3 | 42 | 3 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Randomized) | 4 | 42 | 4 |
| other | Nasopharyngitis | Infections and infestations | Open Label Tasimelteon | 5 | 54 | 6 |
| other | Urinary tract infection | Infections and infestations | Tasimelteon (Randomized) | 3 | 42 | 3 |
| other | Urinary tract infection | Infections and infestations | Placebo (Randomized) | 1 | 42 | 1 |
| other | Urinary tract infection | Infections and infestations | Open Label Tasimelteon | 5 | 54 | 6 |
| other | Alanine aminotransferase increased | Investigations | Tasimelteon (Randomized) | 4 | 42 | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tasimelteon (Randomized) | ||
| Total, all-cause mortality | Placebo (Randomized) | ||
| Total, all-cause mortality | Open Label Tasimelteon | ||
| Total, other adverse events | Tasimelteon (Randomized) | 20 | 42 |
| Total, other adverse events | Placebo (Randomized) | 13 | 42 |
| Total, other adverse events | Open Label Tasimelteon | 21 | 54 |
| Total, serious adverse events | Tasimelteon (Randomized) | 4 | 42 |
| Total, serious adverse events | Placebo (Randomized) | 2 | 42 |
| Total, serious adverse events | Open Label Tasimelteon | 2 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26466871 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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