NCT07363720

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.

Detailed description

The drug being tested in this study is called TAK-861. This study will look at how effective TAK-861 is for the treatment of narcolepsy type 1 and how well this effect is maintained over time. This study also evaluates how safe TAK-861 is and what adverse events may be associated with taking the drug and stopping the drug in participants with NT1. The study will enroll approximately 88 participants. All participants will take TAK-861 during the open-label (OL) treatment period. Participants who meet certain criteria at the end of the OL Treatment Period will be randomized to one of two treatment groups for the up to 4-week double-blind randomized withdrawal (RW) Period. Participants will be randomized to one of the following treatment groups during the Double-blind RW Period: 1. TAK-861 (same dose participant was taking at the end of the OL Treatment Period) 2. Placebo The randomized withdrawal period may last up to 4 weeks. Participants whose NT1 symptoms get worse during the RW period and whose Epworth Sleepiness Scale score rises above a certain score will stop the treatment and be invited to continue in a separate long term extension study. Participants who choose not to take part in the extension study will be followed-up for 4 weeks after their last dose of study drug. This multi-center trial will be conducted globally.

Conditions

• Narcolepsy Type 1 (NT1)
• Narcolepsy With Cataplexy

Interventions

Type	Name	Description
DRUG	TAK-861	TAK-861 tablets
DRUG	Placebo	TAK-861-matching placebo tablets

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-10-02
• Completion: 2026-10-02
• First posted: 2026-01-23
• Last updated: 2026-03-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study