Open-label single dose trial to evaluate pharmacokinetics, safety, and acceptability/palatability of oveporexton in children from 6 years to less than 18 years of age with narcolepsy type 1 (NT1)

2025-522034-31-00 · tracked via the Priya Life Science EU tracker

Sponsor

Takeda Development Center Americas Inc.

Sponsor type

Pharmaceutical company

Therapeutic area

Nervous System Diseases

Decision date

27/11/2025

Enrollment target

Sites

Italy

Condition studied

Narcolepsy with Cataplexy (Narcolepsy Type 1)

Investigational medicinal product(s)

TAK-861TAK-861TAK-861

Eligibility

Age group

0-17 years

Sex

Female, Male

Primary endpoint

Maximum observed concentration (Cmax). Time to reach maximum observed concentration (tmax). Area under the concentration-time curve from time 0 to infinity (AUC∞), calculated using the observed value of the last quantifiable concentration.

Endpoint detail

Occurrence of at least 1 TEAE., Participants rating acceptability and palatability.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522034-31-00 on CTIS ↗ ← All trials in the EU