A Study of TAK-994 in Adults With Narcolepsy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy Type 1 (NT 1)

In brief

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994. Participants will take one of 3 different TAK-994 dose for 8 weeks. Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks. Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo. The study doctors will check for side effects from TAK-994 and placebo throughout the study. Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

Key facts

Study ID

NCT04820842

Run by

Takeda

People needed

26

Starts

2021-04-30

Expected to finish

2021-11-03

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

You may not qualify if…

• Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.

Where it is running

• Mayo Clinic Arizona 300151190 — Phoenix, Arizona, United States
• CITrials - Bellflower — Bellflower, California, United States
• Santa Monica Clinical Trials — Los Angeles, California, United States
• Stanford School of Medicine — Redwood City, California, United States
• Pacific Research Network, Inc 150118105 — San Diego, California, United States
• SDS Clinical Trials, Inc. — Santa Ana, California, United States
• Alpine Clinical Research Center 1024762 — Boulder, Colorado, United States
• Delta Waves Sleep Disorders and Research Center 300148510 — Colorado Springs, Colorado, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Sleep Medicine Specialists of South Florida — Miami, Florida, United States
• Clinical Site Partners, LLC — Miami, Florida, United States
• JSV Clinical Research Study, Inc — Tampa, Florida, United States
• Florida Pulmonary Research Institute, LLC 300127039 — Winter Park, Florida, United States
• NeuroTrials Research, Inc. 300116336 — Atlanta, Georgia, United States
• Sleep Practitioners, LLC Macon — Macon, Georgia, United States
• Clinical Research Institute 300169881 — Stockbridge, Georgia, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Fort Wayne Neurological Center 150711262 — Fort Wayne, Indiana, United States
• University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital — Kansas City, Kansas, United States
• Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420 — Chevy Chase, Maryland, United States
• Beth Israel Deaconess Medical Center CardioVascular Institute — Boston, Massachusetts, United States
• Research Carolina Elite — Denver, North Carolina, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• Raleigh Neurology Associates 300209729 — Raleigh, North Carolina, United States
• Wright Clinical Research — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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