INFO at: https://clinicaltrials.gov  

Clinical Trial #: NCT04091425

Title: Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)

      The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime sleepiness (EDS) despite adequate use of CPAP as the primary OSA therapy. 

     The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat participants who have EDS due to OSA despite using CPAP. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single IV dose of TAK-925 in participants with OSA.

     The study will enroll approximately 42 patients. The study will utilize a three-way cross over design with a 24-hour wash-out between each treatment.

On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.

     The multi-center study will be conducted in United States. The patient's participation in the study will last for up to 43 days and include an 8-day stay in the study clinic and a safety follow-up phone call 7 days after the end of treatment.

Sleep Research INFO at: https://clinicaltrials.gov

Clinical Trial #: NCT04091438

Title: A Pharmacokinetic and Safety Study of a Single Intravenous Dose of TAK-925 in Participants With Idiopathic Hypersomnia (IH)

     The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to participants with idiopathic hypersomnia (IH). 

     The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH.

     The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below:

• TAK-925 + Placebo
• Placebo + TAK-925

On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour infusion.

     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.

INFO at: https://clinicaltrials.gov 

Clinical Trial #: NCT03533114 

TITLE: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Objectives:

Primary objective: to evaluate the efficacy of JZP-258 in the treatment of IH.

Secondary objective: to evaluate the safety of JZP-258 in the treatment of IH.

We are not currently involved in an Insomnia Clinical Trial but you may provide your information for future trials by clicking HERE.

 INFO at: https://clinicaltrials.gov 

Clinical Trial #:  NCT04096560 

Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients with Narcolepsy Type 1

  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.