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

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.

Conditions

Narcolepsy Type 1

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Birmingham

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States, 35213

Redwood City

Stanford Center for Sleep Sciences and Medicine, Redwood City, California, United States, 94063

Santa Ana

SDS Clinical Trials, Inc., Santa Ana, California, United States, 92705

Colorado Springs

Delta Waves LLC - Hunt - PPDS, Colorado Springs, Colorado, United States, 80918

Orlando

Florida Pediatric Research Institute, Orlando, Florida, United States, 32803

Atlanta

Neurotrials Research, Atlanta, Georgia, United States, 30342

Gainesville

Georgia Neuro Center, Gainesville, Georgia, United States, 30501

Newton

Neurocare Inc, Newton, Massachusetts, United States, 02459

Novi

Henry Ford Medical Center - Columbus, Novi, Michigan, United States, 48377

Denver

Research Carolina Elite, Denver, North Carolina, United States, 28037

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. 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. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  • 3. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 times the upper limit of normal (ULN).
  • 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
  • 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
  • 6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
  • 7. Participant has epilepsy or history of seizure.
  • 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. Participant has a history of cerebral ischemia, transient ischemic attack (\<5 years ago), or cerebral hemorrhage.
  • 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. Participant has a history of cancer in the past 5 years.

Ages Eligible for Study

16 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2028-02-28