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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517712-29-00

Acronym

TAK-360-2002

Enrollment

Registered

2025-05-06

Start date

2025-05-27

Completion date

Unknown

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Hypersomnia (IH)

Brief summary

Occurrence of at least 1 treatment-emergent adverse event (TEAE) during the trial.

Detailed description

Change from baseline at Week 4 in ESS total score, as compared to placebo., Change from baseline at Week 4 in IHSS total score, as compared to placebo.

Interventions

DRUGTAK-360 placebo (same excipients as TAK-360)

DRUGTAK-360

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of at least 1 treatment-emergent adverse event (TEAE) during the trial.	—

Secondary

Measure	Time frame
Change from baseline at Week 4 in ESS total score, as compared to placebo., Change from baseline at Week 4 in IHSS total score, as compared to placebo.	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026