Trial · NCT07903220
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 53
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retrospective Cohort: Percentage of Participants in Each Treatment Sequence | From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment] | |
| Primary | Retrospective Cohort: Percentage of Participants Who Permanently Discontinued Treatment, Switched Treatment, or Experienced a Change in Treatment Dose | From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment] | |
| Primary | Prospective Cohort: Number of Participants With Permanent Discontinuation, Switch, Interruptions, or Changes in Treatment Dose and Related Reasons | Prospective Cohort: Up to 24 weeks | |
| Primary | Retrospective Cohort and Prospective Cohort: Average Duration on Treatment | Retrospective Cohort: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]; Prospective Cohort: Up to 24 weeks | |
| Primary | Retrospective Cohort and Prospective Cohort: Time to Permanent Discontinuation, Switch, or Change in Treatment Dose | Retrospective Cohort: From diagnosis of NT1 up to enrollment (baseline) [approximately past 5 years from enrollment]; Prospective Cohort: Up to 24 weeks | |
| Primary | Prospective Cohort: Percentage of Participants on Each Pharmacotherapy Who Permanently Discontinued Treatment, Switched Treatment, or Experienced a Change in Treatment Dose | Up to 24 weeks | |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Epworth Sleepiness Scale (ESS) | Up to 24 weeks | The ESS is a validated, subjective, self-administered questionnaire used to measure daytime sleepiness. The questionnaire consists of 8 questions, each describing a common situation (e.g., sitting and reading, watching TV, sitting in a car as a passenger). Participants rate their likelihood of dozing off in each situation on a scale from 0 (would never doze off) to 3 (high chance of dozing off). The total score ranges from 0 to 24. Higher scores indicate greater daytime sleepiness. |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Clinical Global Impression of Severity (CGI-S) | Up to 24 weeks | CGI-S is a 7-point scale used by clinicians to rate the severity of a participant's illness based on a global assessment of observed and reported symptoms, behaviour, and function over the past 7 days. It assesses the overall severity of mental illness relative to the clinician's experience with similar participants and uses a scale from "1= normal, not at all ill" to "7= among the most extremely ill participants". |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Clinical Global Impression of Change (CGI-C) | Up to 24 weeks | CGI-C is a 7-point scale that requires the clinician to assess how much the participant's illness has improved since baseline. Ratings range from "very much improved" (1) to "very much worse" (7). |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Patient Global Impression of Severity (PGI-S) | Up to 24 weeks | The PGI-S is scale for the participant to rate his/her disease severity at the time of assessment on a 5-point scale ranging from a score of 0 ("none") to 4 ("very severe"). |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Patient Global Impression of Change (PGI-C) | Up to 24 weeks | The PGI-C measures change due to treatment relative to PGI-S on a 7-point scale ranging from a score of 1 ("very much improved") to a score of 7 ("very much worse"). |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by the Functional Impacts of Narcolepsy Instrument (FINI) | Up to 24 weeks | The FINI is a participant-reported outcome (PRO) measure of 28-item, 6-domain (Tiredness, Cognitive Functioning, Cataplexy \[for NT1\], Social Activities, Everyday Activities, and Everyday Responsibilities) (FINI v1.0). FINI items evaluate narcolepsy/excessive daytime sleepiness (EDS) symptoms and impacts on daily functioning. All items have a 7-day recall period on a 5-point Likert scale of frequency from "never" to "always" or severity from "not at all" to "very much." For each domain, an average item score is calculated and standardized to a 0 to 100 scale. Lower scores indicate better health/functioning. FINI will be recorded using an ePRO. |
| Primary | Prospective Cohort: Narcolepsy Symptoms Measured by Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score | Up to 24 weeks | The NSS-CT is a clinical tool designed to assess the severity and impact of narcolepsy. The scale consists of 15 items, each addressing different aspects of narcolepsy symptoms: EDS (items 1-7), cataplexy (items 8-10), hallucinations (items 11 and 12), sleep paralysis (items 13 and 14), and disturbed nighttime sleep (item 15). Participants rate the frequency and severity of their symptoms over the past week. Items will be scored on a scale where mild=0-14, moderate=15-28, severe=29-42, very severe=43-57. Higher scores indicate more severe symptoms. NSS-CT will be recorded using an ePRO. |
| Primary | Prospective Cohort: Cataplexy Measured by Weekly Cataplexy Rate (WCR) | Up to 24 weeks | The WCR is a measure of the average number of cataplexy episodes a person experiences in a week. Participants will be asked to complete self-reported cataplexy questions in an e-diary daily for 14 days at each timepoint (1 week before and 1 week after each timepoint). Cataplexy symptoms will also be assessed over timepoints and may include assessment of severity and location of symptoms and impact of symptoms on daily life. WCR and cataplexy symptoms will be recorded using e-diary entries. |
| Primary | 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) | Up to 24 weeks | The SF-12 is a validated questionnaire that measures general HRQoL. It contains one multi-item scale that assesses 8 domains: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Version SF-12v2 Health Survey will be used and scores will be recorded using an ePRO. |
| Secondary | Retrospective Cohort: Age at Enrollment (Baseline) | At enrollment (baseline) | Age will be reported as mean/median. |
| Secondary | Retrospective Cohort: Demographics at Enrollment (Baseline) | At enrollment (baseline) | Demographics characteristics such as sex, country, race will be reported as number/percentage. |
| Secondary | Retrospective Cohort: Number of Participants With Medical History and Clinical Characteristics Including NT1 Diagnosis Details | From NT1 diagnosis up to enrollment (baseline), approximately past 5 years from enrollment | NT1 medical history and clinical characteristics (since NT1 diagnosis or earlier diagnoses of other sleep related conditions) and methods of NT1 diagnosis (from medical chart review) includes details such as: age at onset of narcolepsy symptoms, age at diagnosis of narcolepsy, NT1, and any other sleep-related conditions, family history of NT1, first documented cataplexy, hypersomnolence, sleep paralysis, hypnagogic/hypnopompic hallucination, disrupted nocturnal sleep, and cognitive symptoms, methods used for diagnosis of NT1, time from onset of NT1 symptoms to NT1 diagnosis, height/body weight/body mass index. |
| Secondary | Retrospective Cohort: Number of Participants With Comorbidities | From NT1 diagnosis up to enrollment (baseline), approximately past 5 years from enrollment | Comorbidities since NT1 diagnosis (from medical chart review) will include: * Obesity * Diabetes mellitus * Metabolic disorders * Cardiovascular disease * Hypertension * Sleep conditions (e.g., hypersomnia, insomnia, parasomnia, rapid eye movement \[REM\] sleep behaviour disorder, sleep apnoea, obstructive sleep apnoea, central sleep apnoea, restless legs syndrome, periodic limb movement disorder, and circadian rhythm disorders) * Other neurological conditions (e.g., migraine, multiple sclerosis, Parkinson's disease) * Psychiatric comorbidities (e.g., depression, anxiety, bipolar disorder, attention deficit-hyperactivity disorder, schizophrenia) * Infectious diseases * Autoimmune disorder (e.g., autoimmune thyroid disease, psoriasis, rheumatoid arthritis, transverse myelitis) * Malignancy * Autonomic dysfunction * Substance abuse disorder (e.g., alcohol, tobacco, marijuana) * Back pain * Charlson comorbidity index (derived) score |
| Secondary | Retrospective Cohort: Pharmacological Treatment Outcomes of Narcolepsy Therapies Measured by ESS Total Score | From NT1 diagnosis up to enrollment (baseline), approximately past 5 years from enrollment | The ESS is a validated, subjective, self-administered questionnaire used to measure daytime sleepiness. The questionnaire consists of 8 questions, each describing a common situation (e.g., sitting and reading, watching TV, sitting in a car as a passenger). Participants rate their likelihood of dozing off in each situation on a scale from 0 (would never doze off) to 3 (high chance of dozing off). The total score ranges from 0 to 24. Higher scores indicate greater daytime sleepiness. ESS total score will be recorded using ePRO. |
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.
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