A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with Narcolepsy without Cataplexy (NT2)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517711-70-01

Acronym

TAK-360-2001

Enrollment

Registered

2025-11-14

Start date

2025-12-04

Completion date

Unknown

Last updated

2025-11-21

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

Conditions

Narcolepsy without Cataplexy (NT2)

Brief summary

Occurrence of at least 1 (TEAE) during the trial.

Detailed description

1. Change from baseline at Week4 in ESS total score, as compared with placebo., 2. Change from baseline at Week 4 in mean sleep latency on the MWT, as compared with 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 (TEAE) during the trial.	—

Secondary

Measure	Time frame
1. Change from baseline at Week4 in ESS total score, as compared with placebo., 2. Change from baseline at Week 4 in mean sleep latency on the MWT, as compared with placebo.	—

Countries

France, Italy, Spain

Outcome results

None listed

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