CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
TAK-861 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05687903
NCT05687903Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Takeda·interventional·Posted Jan 18, 2023·Updated Jan 9, 2025

In Brief

A Phase 2 clinical trial evaluating TAK-861 and Placebo for Narcolepsy Type 1. Completed, enrolled 112 participants across 57 sites in 12 countries.

Detailed Summary

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy Type 1
CountriesAustralia, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJan 18, 2023
Enrollment StartJan 9, 2023
Primary CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.5 years ago

Interventions

TAK-861drug

TAK-861 oral tablets

Placebodrug

Placebo oral tablets matching TAK-861