A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508462-15-00

Acronym

TAK-861-2003

Enrollment

304

Registered

2024-03-27

Start date

2023-04-27

Completion date

Unknown

Last updated

2025-09-09

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

Conditions

Narcolepsy with Cataplexy (Narcolepsy Type 1)

Brief summary

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

Detailed description

Change from baseline in the parent study in MWT mean sleep latency., Change from baseline in the parent study in ESS total score, Change from baseline in the parent study in WCR using the patient reported Cataplexy Diary

Interventions

DRUGTAK-861

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).	—

Secondary

Measure	Time frame
Change from baseline in the parent study in MWT mean sleep latency., Change from baseline in the parent study in ESS total score, Change from baseline in the parent study in WCR using the patient reported Cataplexy Diary	—

Countries

Austria, Belgium, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

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