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NCT06812078

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

StatusRecruiting
PhasePhase 2
SponsorTakeda
Primary completion (estimated)
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Record History

All 12 versions: 12 with changes below.

  1. Primary and study completion pushed from Jul 16, 2026 to Nov 30, 2026v12
  2. Site details revised at 2 of 29 sitesv11
  3. Site details revised at 2 of 29 sitesv10
  4. Enrollment target: 40 to 96
    • Primary and study completion dates: Feb 19, 2026 to Jul 16, 2026
    v9
  5. Site details revised at 1 of 29 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 29 sitesv7
  2. Site details revised at 3 of 29 sitesv6
  3. Site details revised at 4 of 29 sitesv5
  4. Site details revised at 4 of 29 sitesv4
  5. Study sites: 25 to 29v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 25
    • Start date changed from estimate of Feb 14, 2025 to Feb 7, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Week 8

Secondary (2)

Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score

Arms and interventions

TAK-360Experimental

Participants will receive TAK-360 tablets, orally, for 4 weeks.

PlaceboPlacebo comparator

Participants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.

Drugs: TAK-360

Other: Placebo

Sites

29 sites in 6 countries

United States 13, Japan 6, Italy 4, France 3, Spain 2, Hong Kong 1