Trial · NCT04803786
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
NCT04803786, Completed, Jazz Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy. Trials, record NCT04803786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04803786
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
- NCT number
- NCT04803786
- Status
- Completed
- Enrollment
- 110 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Narcolepsy
- Interventions
- Transition from Xyrem to Xywav
- First posted
- 2021-03-18
- Last updated
- 2022-06-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav | Baseline to 21 Weeks | • Difference between usual Xyrem total nightly dose and initial prescribed total nightly Xywav dose. |
| Secondary | Number Prescribed Dose Adjustments of Xywav | Baseline to 21 Weeks | The number of dosing adjustments per participants and number of participants with one or more dosing adjustments during the Xywav Treatment Period (Period 2 to 5) by treating physician (dosing amount or number of nightly doses), details of adjustment, reason for adjustment and reason for unequal dosing will be summarized. |
| Secondary | Duration of Time Between the Last Meal Relative to Dosing | Baseline to 21 Weeks | Timing and type of last meal prior to the first dose will be collected using both Daily Diary and Weekly Lookback of Daily Diary. The timing will be collected as actual time (HH:MM) from Daily Diary and as categorical data of usual number of hours relative to first dose (\<0.5 hours, ≥0.5 but \<1 hours, ≥1 but \<1.5 hours, ≥1.5 but \<2 hours, ≥2 hours) from Weekly Lookback of Daily Diary. In order to evaluate the timing of last meal across all study periods, the Daily Diary entry will be converted into categorical data using the same value scale as Weekly Lookback of Daily Diary. The type of last meal prior to the first dose will be collected as categorical data (regular meal, snack, and beverage). For both timing and type of last meal prior to the first dose, the number of participants with each response will be summarized. |
| Other | Time to Achieve Stable Dose of Xywav | Baseline to 21 Weeks | Stable dose is defined as the dose and regimen which remain unchanged for at least 2 weeks. Compliance is not considered in the derivation of the time to stable dose. The time to achieve stable dose will be summarized. |
| Other | Number of Participants Achieving Treatment Adherence | Baseline to 21 Weeks | Skipped doses will be collected using both the Daily Diary and Weekly Lookback Daily Diary. Skipped doses will be collected daily (yes/no) from the Daily Diary and as a weekly categorical variable (0, 1-2, 3-4, 5-6, or 7 days) from the Weekly Lookback of Daily Diary. In order to summarize skipped doses during the Xywav Treatment Period, the Daily Diary data will be converted to categorical data using the same categories as in the Weekly Lookback of Daily Diary. Skipped doses per week (0, 1-2, 3-4, 5-6, 7 days), most common dosing change (did not take Xywav, skipped first dose, skipped second dose, skipped third dose) and most common reasons for dosing change will be summarized. |
| Other | Number of Participants Who Discontinued Xywav Administration | Baseline to 21 Weeks | The number of participants who discontinued Xywav administration during the Xywav Treatment Period (Period 2 to 5). |
| Other | Change in Short-term and Long-term Nausea Using Patient Global Impression of Change (PGI-C) | Baseline to 21 Weeks | The PGI-C is a series of self-administered questions designed to measure the meaningfulness of change in symptoms following an intervention. The PGI-C is used to assess the change in excessive daytime sleepiness, cataplexy, and short- and long-term nausea since the transition from Xyrem to Xywav. It is a 7-point Likert-type rating scale from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, to 7 = very much worse. The score is the sum of responses to each of the answer choices. |
| Other | Changes in Sleep Pattern and Quality | Baseline to 21 Weeks | Sleep pattern (how long usually took to fall asleep after the first dose, how long usually spent awake during the night) will be summarized. Sleep pattern and quality will be collected using both Daily Diary and Weekly Lookback of Daily Diary. The number of participants with each response to sleep quality (very poor \~ very good) and feeling on how rested/refreshed when woke-up for the day (not at all rested \~ very well rested) will be summarized by day and by week. In order to analyze the data together the intention is to combine the daily by deriving the categorical frequency for the responses so that it can be combined with the categorical data collected in the weekly diary. Which will allow for a full analysis of the change from the Baseline period (Xyrem) to Xywav Treatment Period (Period 2 to 5) will be summarized for weekly data collected during the Xywav Treatment Period (Period 2 to 5) using Weekly Lookback of Daily Diary. |
| Other | Change in Epworth Sleepiness Scale (ESS) | Baseline to 21 Weeks | The ESS is a self-administered questionnaire with 8 questions (Johns 1991, Johns 1992). Respondents rate on a 4-point scale (0-3) their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS total score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher ESS total scores are associated with higher sleep propensity in daily life, also referred to as 'daytime sleepiness'. The ESS has been validated in several conditions, including narcolepsy (Johns 1994). |
| Other | Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score | Baseline to 21 Weeks | The FOSQ-10 (Chasens 2009) is a self-administered questionnaire designed to assess the impact of daytime sleepiness on activities of daily living. It consists in 10 items measuring the participant's general productivity, activity level, vigilance, and intimacy and sexual relationships. For each item, participants are asked to rate the level of difficulty in completing an activity on a 4-point Likert scale, from 1 "Yes, extreme" to 4 "No"). From the FOSQ-10 a total score is calculated: a higher score indicates better functional status. The FOSQ-10 is a reduced version of the original FOSQ-30. The FOSQ-10 was tested and found to be a psychometrically strong instrument performing similarly to the long version. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT04803786
GET https://conductscience.org/api/trials/v1/NCT04803786/registered