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HYPNOSNCT07299097

Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

StatusActive, Not Recruiting
PhaseNot specified
SponsorTakeda
Primary completion (estimated)

At risk: Primary completion moved 5 months later across 2 updates.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words Show 4 more changesShow less
    • Primary endpoints: details revised at 2 of 11 entries
    • Primary and study completion pushed from Sep 30, 2026 to Dec 31, 2026
    • Secondary endpoints: details revised at 8 of 30 entries
    • Site details revised at 1 of 10 sites
  2. Enrollment closed, study ongoing
    • Primary and study completion pushed from Jul 31, 2026 to Sep 30, 2026
    • Final enrollment: 402 participants (planned 100)
    • Site details revised at 10 of 10 sites
    v4
  3. Primary and study completion pushed from May 30, 2026 to Jul 31, 2026v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of Dec 30, 2025 to Dec 2, 2025
    • Secondary endpoints revised (30)
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population
Timeframe: Up to 1 year
Core Group: Prevalence of Adult Participants With NT1 and NT2 per 100,000 Adult Population
Timeframe: Up to 1 year
Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Timeframe: Up to 1 year
Core Group: Prevalence of Male Participants With NT1 and NT2 per 100,000 Male Population
Timeframe: Up to 1 year
Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population
Timeframe: Up to 1 year
Core Group: Incidence of NT1 and NT2 per 100,000 Population
Timeframe: Up to 2 years
Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population
Timeframe: Up to 2 years
Core Group: Incidence of Paediatric/Adolescent NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Timeframe: Up to 2 years
Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population
Timeframe: Up to 2 years
Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population
Timeframe: Up to 2 years
Supplementary Group: Number of Participants with NT1 and NT2 who Attend Regular Follow-ups
Timeframe: On a day of survey (any 1 day) during the study for each participant

Secondary (30)

Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years
Show 25 moreShow less
Core Group: Percentage Change in Adult With NT1 and NT2 Prevalence Over Past 10 Years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years
Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years
Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Incidence Over Past 10 Years
Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2
Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2
Core Group: Diagnostic Delay for Incident Paediatric/Adolescent Participants with NT1 and NT2
Core Group: Diagnostic Delay for Incident Male Participants with NT1 and NT2
Core Group: Diagnostic Delay for Incident Female Participants with NT1 and NT2
Core Group: Percentage Change in Diagnostic Delay for Participants With NT1 and NT2 Over Past 10 Years
Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 10 Years
Core Group: Percentage Change in Diagnostic Delay for Paediatric/Adolescent Participants With NT1 and NT2 Over Past 10 Years
Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years
Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years
Supplementary Group: Proportion of Participants With NT1 and NT2 who Were Diagnosed at Public hospitals and Private Practices
Supplementary Group: Proportion of Participants who Choose to be Followed in Public, Private, or Both Types of Hospitals and Reasons
Supplementary Study: Age at Symptom Onset
Supplementary Study: Age at Diagnosis
Supplementary Study: Proportion of Participants as per Speciality of the Doctor Visited First for Narcolepsy Symptoms
Supplementary Study: Proportion of Participants as per Speciality of the Doctor who Diagnosed Narcolepsy
Supplementary Study: Number of Doctors Visited by Participant Prior to Receiving a Narcolepsy Diagnosis
Supplementary Study: Proportion of Participants With Misdiagnosis Prior to Narcolepsy Diagnosis
Supplementary Study: Proportion of Participants with Comorbidities
Supplementary Study: Proportion of Participants as per Place of Residence (Autonomous Community)

Arms and interventions

Core Group

Participants with Narcolepsy Type (NT1) and Narcolepsy Type (NT2) of any age, ethnicity and nationality, treated / under follow-up in approximately 10 Spanish public hospitals, who are alive at any point during 2023 or 2024, residing in the hospitals' reference areas will be retrospectively observed through chart reviews. The retrospective data for up to approximately 10 years would be assessed.

Supplementary Group

Participants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group.

Other: No intervention

Sites

10 sites in 1 country