A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 70
Healthy Volunteers: f
View:
• 1\. Participant with a diagnosis of NT1 who has completed a controlled study with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
Locations
United States
Alabama
Sleep Disorders Center of Alabama
RECRUITING
Birmingham
California
Stanford Center for Sleep Sciences and Medicine
RECRUITING
Redwood City
SDS Clinical Trials, Inc.
RECRUITING
Santa Ana
Colorado
Delta Waves LLC - Hunt - PPDS
RECRUITING
Colorado Springs
Florida
Florida Pediatric Research Institute
RECRUITING
Orlando
Georgia
Neurotrials Research
RECRUITING
Atlanta
Georgia Neuro Center
RECRUITING
Gainesville
Massachusetts
Neurocare Inc
RECRUITING
Newton
Michigan
Henry Ford Medical Center - Columbus
RECRUITING
Novi
North Carolina
Research Carolina Elite
RECRUITING
Denver
ARSM Research, LLC
RECRUITING
Huntersville
Ohio
CTI Research Center
RECRUITING
Cincinnati
Intrepid Research
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio Sleep Medicine Institute
RECRUITING
Dublin
South Carolina
Medical University of South Carolina - PPDS
RECRUITING
Charleston
Bogan Sleep Consultants, LLC
RECRUITING
Columbia
Texas
Sleep Therapy and Research Center
RECRUITING
San Antonio
Virginia
Children's Specialty Group
RECRUITING
Norfolk
Other Locations
Australia
Woolcock Institute of Medical Research
RECRUITING
Glebe
Finland
Terveystalo Helsinki Sleep Clinic
RECRUITING
Helsinki
France
CHU de Grenoble
RECRUITING
La Tronche
CHU Gui De Chauliac
RECRUITING
Montpellier
Hopital de la Pitie Salpetriere
RECRUITING
Paris
Hopital Pierre-Paul Riquet
RECRUITING
Toulouse
Germany
Charite - Universitatsmedizin Berlin
RECRUITING
Berlin
Klinische Forschung Hamburg
RECRUITING
Hamburg
Universitaet Regensburg am Bezirksklinikum
RECRUITING
Regensburg
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
RECRUITING
Schwerin
Italy
Ospedale Bellaria
RECRUITING
Bellaria
Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Fondazione PTV Policlinico Tor Vergata
RECRUITING
Rome
Japan
Koishikawa Tokyo Hospital
RECRUITING
Bunkyo-ku
Howakai Kuwamizu Hospital
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume-shi
Aichi Medical University Hospital
RECRUITING
Nagakute
YOU ARIYOSHI Sleep Clinic
RECRUITING
Nagasaki
Gokeikai Osaka Kaisei Hospital
RECRUITING
Osaka
Netherlands
Slaap-Waakcentrum SEIN Heemstede
RECRUITING
Heemstede
Kempenhaeghe - PPDS
RECRUITING
Heeze
Norway
University of Oslo
RECRUITING
Oslo
Spain
Hospital de La Ribera
RECRUITING
Alzira
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital General de Castello
RECRUITING
Castellon
Hospital Vithas Madrid Arturo Soria
RECRUITING
Madrid
Instituto de Investigaciones del Sueno
RECRUITING
Madrid
Hospital Universitario Araba Santiago
RECRUITING
Vitoria-gasteiz
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Switzerland
Klinik Barmelweid AG
RECRUITING
Barmelweid
Universitaetsspital Bern - Inselspital
RECRUITING
Bern
Neurocenter of Southern Switzerland
RECRUITING
Lugano
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 500
Treatments
Experimental: TAK-861 Dose 1
Participants will receive TAK-861 dose 1 for up to approximately 5 years.
Experimental: TAK-861 Dose 2
Participants will receive TAK-861 dose 2 for up to approximately 5 years.
Related Therapeutic Areas
Sponsors
Leads: Takeda