Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059563) titled 'Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia in Japan' on Nov. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Takeda Pharmaceutical Company Limited
Condition:
Condition - Narcolepsy, Idiopathic hypersomnia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Estimate total costs and EuroQol-5 Dimension (EQ-5D)-derived health utilities among patients with Narcolepsy type 1, Narcolepsy type 2, and Idiopathic hypersomnia summarized by disease severity levels measured by the Japanese version of the Epworth Sleepiness Scale.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Having a self-reported diagnosis of narcolepsy or IH
2. Aged 18 years or older at the time of enrolment into study
3. Can read and understand Japanese
4. Willing to participate in the study and complete the questionnaire, and have accepted the informed consent form
Key exclusion criteria - Currently enrolled in any clinical trial
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 29 Day
Date of IRB - 2025 Year 09 Month 18 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068123
Disclaimer: Curated by HT Syndication.
