RETRACENCT07903220
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Retrospective Cohort: Percentage of Participants in Each Treatment Sequence
Timeframe: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]
Retrospective Cohort: Percentage of Participants Who Permanently Discontinued Treatment, Switched Treatment, or Experienced a Change in Treatment Dose
Timeframe: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]
Prospective Cohort: Number of Participants With Permanent Discontinuation, Switch, Interruptions, or Changes in Treatment Dose and Related Reasons
Timeframe: Prospective Cohort: Up to 24 weeks
Retrospective Cohort and Prospective Cohort: Average Duration on Treatment
Timeframe: Retrospective Cohort: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]; Prospective Cohort: Up to 24 weeks
Retrospective Cohort and Prospective Cohort: Time to Permanent Discontinuation, Switch, or Change in Treatment Dose
Timeframe: Retrospective Cohort: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]; Prospective Cohort: Up to 24 weeks
Prospective Cohort: Percentage of Participants on Each Pharmacotherapy Who Permanently Discontinued Treatment, Switched Treatment, or Experienced a Change in Treatment Dose
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Epworth Sleepiness Scale (ESS)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Clinical Global Impression of Severity (CGI-S)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Clinical Global Impression of Change (CGI-C)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Patient Global Impression of Severity (PGI-S)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Patient Global Impression of Change (PGI-C)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by the Functional Impacts of Narcolepsy Instrument (FINI)
Timeframe: Up to 24 weeks
Prospective Cohort: Narcolepsy Symptoms Measured by Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
Timeframe: Up to 24 weeks
Prospective Cohort: Cataplexy Measured by Weekly Cataplexy Rate (WCR)
Timeframe: Up to 24 weeks
Prospective Cohort: Health-Related Quality of Life (HRQoL) Measured by the 12-Item Short Form Health Survey (SF-12) (Physical Component Summary [PCS] and Mental Component Summary [MCS] Scores)
Timeframe: Up to 24 weeks
Secondary (38)
Retrospective Cohort: Age at Enrollment (Baseline)
Retrospective Cohort: Demographics at Enrollment (Baseline)
Retrospective Cohort: Number of Participants With Medical History and Clinical Characteristics Including NT1 Diagnosis Details
Retrospective Cohort: Number of Participants With Comorbidities
Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by ESS Total Score
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Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by CGI-S Scores
Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by WCR
Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by Narcolepsy Severity Scale (NSS) Total Score
Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
Retrospective Cohort and Prospective Cohort: Healthcare Resource Utilization (HCRU): Number of Visits
Retrospective Cohort and Prospective Cohort: HCRU: Number of Hospitalizations as Per Reasons
Retrospective Cohort and Prospective Cohort: HCRU: Length (in Days) of Hospitalizations as Per Reasons
Retrospective Cohort and Prospective Cohort: HCRU: Number of Procedures Because of NT1 Symptoms or Complications (Maintenance of Wakefulness Test, Multiple Sleep Latency Test, Polysomnography)
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by ESS Total Score
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by "Adaptive Behaviors to Cataplexy Symptoms" as Assessed Through a Study-specific Questionnaire
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by PGI-S
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by "Pharmacotherapy Adherence to Treatment" as Assessed Through a Study-specific Questionnaire
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by SF-12 PCS and MCS Scores
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by FINI Domain Scores
Retrospective Cohort: HRQoL and Clinical Outcomes Measured by NSS-CT Total Score
Retrospective Cohort: Treatment Satisfaction Measured by Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9)
Prospective Cohort: Treatment Use of Pitolisant and/or Sodium Oxybate
Prospective Cohort: Treatment Regimen for Pitolisant and/or Sodium Oxybate
Prospective Cohort: Duration of Treatment With Pitolisant and/or Sodium Oxybate
Prospective Cohort: Treatment Regimen Adjustment for Pitolisant and/or Sodium Oxybate
Prospective Cohort: Use of Concomitant Medications With Pitolisant and/or Sodium Oxybate
Prospective Cohort: Change From Baseline in ESS Total Score
Prospective Cohort: Perceived Change From Baseline in PGI-S Score
Prospective Cohort: Perceived Change From Baseline in CGI-S Score
Prospective Cohort: Change From Baseline in PGI-C Score
Prospective Cohort: Change From Baseline in CGI-C Score
Prospective Cohort: Change From Baseline in WCR
Prospective Cohort: Change From Baseline in Adaptive Behaviors to Cataplexy Symptoms
Prospective Cohort: Change From Baseline in Domain Scores Measured by FINI
Prospective Cohort: Change From Baseline in Domain Scores Measured by NSS-CT Total Score
Prospective Cohort: Change From Baseline in Domain Scores Measured by SF-12 PCS and MCS Scores
Prospective Cohort: Change From Baseline in Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
Prospective Cohort: Adherence to Treatment Measured by E-Diary Over 24 weeks
Arms and interventions
Retrospective Cohort With a Cross-Sectional Survey Component
Data will be collected for participants with NT1 who previously initiated (within 5 years before enrollment) any treatment for narcolepsy in a real-world clinical setting via medical chart review and a one-time cross-sectional participant survey at time of entry in the study/enrollment.
Prospective Cohort
Data will be collected for up to 24 weeks for participants with NT1 who plan to initiate treatment with pitolisant or sodium oxybate, as monotherapy or combined with any other narcolepsy pharmacotherapy, on the day of or within 28 days after enrollment. Eligible participants from the retrospective cohort may be enrolled in the prospective cohort. Data will be collected via electronic questionnaires called patient reported outcomes (ePROs) and electronic diaries in addition to retrospective medical chart review.
Other: No intervention