NCT05687916

A Study of TAK-861 in Participants With Narcolepsy Type 2

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Detailed description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy \[Narcolepsy Type 2 (NT2)\]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861. The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-861 Dose 1 * TAK-861 Dose 2 * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

Conditions

• Narcolepsy Type 2

Interventions

Type	Name	Description
DRUG	Placebo	TAK-861 placebo matching tablets.
DRUG	TAK-861 2 mg	TAK-861 2 mg tablets.
DRUG	TAK-861 2 mg and 5 mg	TAK-861 2 mg and 5 mg tablets.

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-12-13
• Completion: 2023-12-25
• First posted: 2023-01-18
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

56 sites across 12 countries: United States, Australia, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland

Regulatory

• FDA-regulated drug study