๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-03

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions (NCT05816382)

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

๐ŸŸข Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Takeda

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Who can join: Review the eligibility criteria below.

Location: Sleep Disorders Center of Alabama โ€” Birmingham, Alabama

Age range: 16 Years to 70 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (52 Sites)

Showing the first 25 of 52 sites.

  • Sleep Disorders Center of Alabama โ€” Birmingham, Alabama
  • Stanford Center for Sleep Sciences and Medicine โ€” Redwood City, California
  • SDS Clinical Trials, Inc. โ€” Santa Ana, California
  • Delta Waves LLC - Hunt - PPDS โ€” Colorado Springs, Colorado
  • Florida Pediatric Research Institute โ€” Orlando, Florida
  • Neurotrials Research โ€” Atlanta, Georgia
  • Georgia Neuro Center โ€” Gainesville, Georgia
  • Neurocare Inc โ€” Newton, Massachusetts
  • Henry Ford Medical Center - Columbus โ€” Novi, Michigan
  • Research Carolina Elite โ€” Denver, North Carolina
  • ARSM Research, LLC โ€” Huntersville, North Carolina
  • CTI Research Center โ€” Cincinnati, Ohio
  • Intrepid Research โ€” Cincinnati, Ohio
  • The Cleveland Clinic Foundation โ€” Cleveland, Ohio
  • Ohio Sleep Medicine Institute โ€” Dublin, Ohio
  • Medical University of South Carolina - PPDS โ€” Charleston, South Carolina
  • Bogan Sleep Consultants, LLC โ€” Columbia, South Carolina
  • Sleep Therapy and Research Center โ€” San Antonio, Texas
  • Children's Specialty Group โ€” Norfolk, Virginia
  • Woolcock Institute of Medical Research โ€” Glebe, New South Wales
  • Terveystalo Helsinki Sleep Clinic โ€” Helsinki, Uusimaa
  • Hopital Pierre-Paul Riquet โ€” Toulouse, Haute-Garonne
  • CHU Gui De Chauliac โ€” Montpellier, Herault
  • CHU de Grenoble โ€” La Tronche, Isere
  • Hopital de la Pitie Salpetriere โ€” Paris,

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 825-3327

Email: medinfoUS@takeda.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—