Study to Evaluate the Efficacy And Safety of Tak-861 for the Treatment of Narcolepsy With Cataplexy

Overview

About this study

The purpose of this study is to evaluate the efficacy and safety of TAK-861 in people with narcolepsy type 1 (NT1).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2).
  2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
  3. The participant has ≥4 partial or complete episodes of cataplexy/week (WCR).
  4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is ≤110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay].

Exclusion Criteria:

  1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
  2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
  3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
  4. The participant has a history of cancer in the past 5 years.
  5. The participant has a clinically significant history of head injury or head trauma.
  6. The participant has a history of epilepsy, seizure, or convulsion.
  7. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/9/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Open for enrollment

Contact information:

Latasha Bunkley

(480) 342-2906

Bunkley.Latasha@mayo.edu

More information

Publications

Publications are currently not available