A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522587-33-00

Enrollment

Registered

2026-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Narcolepsy with Cataplexy (NT1)

Brief summary

Occurrence of at least 1 TEAE during the trial.

Detailed description

1. Parts A and B: Change from baseline in mean sleep latency from the MWT at Week 6., 2. Parts A and B: Change from baseline in ESS total score at Week 6., 3. Parts A and B: WCR at Week 6.

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. Parts A and B: Change from baseline in mean sleep latency from the MWT at Week 6., 2. Parts A and B: Change from baseline in ESS total score at Week 6., 3. Parts A and B: WCR at Week 6.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 23, 2026