SPARKLE 1501 for Narcolepsy Type 1 (NT1)

Summary

The purpose of this study is to assess the safety and tolerability of TAK-994 following multiple oral doses in participants with narcolepsy type 1 (NT1).

Description

The drug being tested in this study is called TAK-994.

The study will enroll up to approximately 72 patients. Participants will be randomly assigned (by chance, like flipping a coin) in 2:1 ratio to one of the two treatment groups as 3 Cohorts:

  • Cohort 1: TAK-994 tablets dose Level 1 or placebo
  • Cohort 2: TAK-994 tablets TBD or placebo
  • Cohort 3: TAK-994 tablets TBD or placebo

This multi-center trial will be conducted in the North America and Japan. The overall duration of the study is 35 days. Participants will be followed up for 7 days after the last dose of study drug.

ClinicalTrials.gov Identifier

NCT04096560

SPARKLE 2001 for Obstructive Sleep Apnea (OSA) with Excessive Daytime Sleepiness (EDS)

Summary

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 current use of continuous positive airway pressure (CPAP) as the primary OSA therapy.

Description

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 overall duration of this study is approximately 43 days. Participants will make multiple visits to the clinic and will be followed up for 7 days after the end of treatment for safety follow-up.

ClinicalTrials.gov Identifier

NCT04091425

SPARKLE 2002 for Idiopathic Hypersomnia (IH)

Summary

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).

Description

The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat participants who have IH. 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:

  • 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 multicentre study will be conducted in US and Japan. The overall duration of treatment in this study is approximately 39 days. Participants make multiple visits to the clinic and will be followed up 7 days after the end of treatment for safety follow-up

ClinicalTrials.gov Identifier

NCT04091438