INFO at: https://clinicaltrials.gov
Clinical Trial #: NCT04096560
Title: A Study of TAK-994 in Participants With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 [NT1] or Narcolepsy Type 2 [NT2])
The drug being tested in this study in participants with IH is called TAK-994. This is a phase 1, randomized, double-blind, placebo-controlled, multiple-rising dose study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple rising oral doses of TAK-994 administered to patients with narcolepsy type 1 (NT1). Up to 3 dose cohorts will be enrolled with 18 patients with NT1 each in the first 2 dose cohorts and 36 patients with NT1 in the last cohort. Each cohort will be randomized in a ratio of 2:1 to receive TAK-994 or matching placebo orally as a tablet formulation. Subjects will receive twice-daily dosing of TAK-994 or matching placebo for 28 days. Blinded data review will be performed by the sponsor at the end of each cohort. Safety and tolerability, progression to the next cohort, and dose will be determined during that review
The multicenter study will be conducted in the US and Japan. The overall duration of treatment in this study is approximately 43 days including up to 28 day screening period and a follow-up safety visit 7 days post last dose for all.