Trial · NCT01021813
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ) | Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out]) | Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
| SECONDARY | Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase | Baseline, Week 1, Week 2, Week 3, and Week 4 | Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase | Baseline, Week 1, Week 2, Week 3, and Week 4 | Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint. | minutes | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS) | From the first day of study treatment through study follow-up (up to 14 months) | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01021813/outcomes