RECRUITING

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

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Conditions

Narcolepsy Type 1Drug Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-05
Study Completion:2028-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05816382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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.
  1. 1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
  2. 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  3. 3. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 times the upper limit of normal (ULN).
  4. 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
  5. 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
  6. 6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
  7. 7. Participant has epilepsy or history of seizure.
  8. 8. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
  9. 9. Participant has a history of cerebral ischemia, transient ischemic attack (\<5 years ago), or cerebral hemorrhage.
  10. 10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
  11. 11. Participant has a history of cancer in the past 5 years.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, 94063
United States
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
United States
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, 80918
United States
Florida Pediatric Research Institute
Orlando, Florida, 32803
United States
Neurotrials Research
Atlanta, Georgia, 30342
United States
Georgia Neuro Center
Gainesville, Georgia, 30501
United States
Neurocare Inc
Newton, Massachusetts, 02459
United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
United States
Research Carolina Elite
Denver, North Carolina, 28037
United States
ARSM Research, LLC
Huntersville, North Carolina, 28078
United States
CTI Research Center
Cincinnati, Ohio, 45212
United States
Intrepid Research
Cincinnati, Ohio, 45227
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
United States
Medical University of South Carolina - PPDS
Charleston, South Carolina, 29425
United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
United States
Sleep Therapy and Research Center
San Antonio, Texas, 78229
United States
Children's Specialty Group
Norfolk, Virginia, 23510
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05
Study Completion Date2028-02-28

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2028-02-28

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Narcolepsy Type 1