jRCT2031240669RecruitingNot Applicable
A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with Idiopathic Hypersomnia (IH)
Takeda Pharmaceutical Company Limited0 sites40 target enrollmentStarted: February 7, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Primary Endpoint
- Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to 70age old under (—)
- Sex
- All
Inclusion Criteria
- •The participant weighs greater than or equal to (>=) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
- •The participant has a documented, current diagnosis of IH.
Exclusion Criteria
- •The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
- •The participant has medically significant thyroid disease.
- •The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
- •The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
- •The participant has a clinically significant history of head injury or head trauma.
- •The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- •The participant has a history of cerebral ischemia, transient ischemic attack (less than [<]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
- •The participant has any prior exposure to an oral Takeda orexin receptor 2 (OX2R) agonist within the past 3 months.
Outcomes
Primary Outcomes
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 8
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Secondary Outcomes
- Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score(Baseline, Week 4)
- Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score(Baseline, Week 4)
Investigators
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