Trial · NCT01429116
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
NCT01429116, Phase 3, Completed, Vanda Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception. Trials, record NCT01429116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01429116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
- NCT number
- NCT01429116
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Interventions
- tasimelteon
- First posted
- 2011-09-05
- Last updated
- 2015-04-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Treatment-Emergent Adverse Events (AEs) | 24 months + 12 month optional extension | Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE. |
| Secondary | Number of participants with changes in Clinical Laboratory Data | 24 months + 12 month optional extension | Standard Serum Hematology and Chemistry tests will be performed at baseline and through the 24 months of treatment |
| Secondary | Number of participants with newly occurring or worsening ECG abnormalities | 24 months + 12 month optional extension | |
| Secondary | Number of participants with clinically notable Vital Signs and Body Measurements | 24 months + 12 month optional extension | |
| Secondary | Number of participants who report a positive result for the Columbia Suicide Severity Rating Scale (C-SSRS) | 24 months + 12 month optional extension |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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.
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/NCT01429116
GET https://conductscience.org/api/trials/v1/NCT01429116/registered