At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Placebo, TAK-861 2 mg, and 1 other intervention for Narcolepsy Type 2. Completed, enrolled 71 participants across 56 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
TAK-861 placebo matching tablets.
TAK-861 2 mg tablets.
TAK-861 2 mg and 5 mg tablets.