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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Narcolepsy Type 1
• Intervention / Treatment: Drug: TAK-861

Detailed Description

The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.

This trial was initiated in parallel with the parent phase 2 trials, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) trial enrolled participants with both diagnoses from the two phase 2 trials. As the TAK-861-2002 trial did not meet prespecified criteria, all participants with NT2 were discontinued, and moving forward this extension study only includes participants with NT1 who previously completed a parent trial. Parent trials include all TAK-861 phase 3 trials in addition to the phase 2 trial participants from TAK-861-2001.

The trial will enroll up to 500 participants. All participants in the trial will receive TAK-861. Participants who were previously on a placebo dose will be assigned to one of the TAK-861 doses randomly.

This multi-center trial will be conducted worldwide. Study period is approximately 5 years or until the study is stopped at the sponsor's discretion, or the product is approved and launched. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of trial intervention.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Australia
  • New South Wales
    • Glebe, New South Wales, Australia, 2037
      • Recruiting
      • Woolcock Institute of Medical Research
• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00380
      • Recruiting
      • Terveystalo Helsinki Sleep Clinic
• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital de la Pitié Salpétrière
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31000
      • Recruiting
      • Hôpital Pierre-Paul Riquet
  • Herault
    • Montpellier, Herault, France, 34090
      • Recruiting
      • CHU Gui de Chauliac
  • Isere
    • La Tronche, Isere, France, 38700
      • Recruiting
      • CHU de Grenoble
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
  • Hamburg, Germany, 20253
    • Recruiting
    • Klinische Forschung Hamburg
  • Bavaria
    • Regensburg, Bavaria, Germany, 93053
      • Recruiting
      • Universitaet Regensburg am Bezirksklinikum
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
      • Recruiting
      • Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
• Italy
  • Bellaria, Italy, 40139
    • Recruiting
    • Ospedale Bellaria
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Recruiting
      • Fondazione Ptv Policlinico Tor Vergata
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • Recruiting
      • Istituto Neurologico Mediterraneo Neuromed
• Japan
  • Nagakute, Japan, 480-1195
    • Recruiting
    • Aichi Medical University Hospital
  • Hukuoka
    • Kurume-Shi, Hukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 862-0954
      • Recruiting
      • Howakai Kuwamizu Hospital
  • Nagasaki
    • Nagasaki, Nagasaki, Japan, 850-0045
      • Recruiting
      • YOU ARIYOSHI Sleep Clinic
  • Osaka
    • Osaka, Osaka, Japan, 532-0003
      • Recruiting
      • Gokeikai Osaka Kaisei Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 112-0012
      • Recruiting
      • Koishikawa Tokyo Hospital
• Netherlands
  • North Brabant
    • Heeze, North Brabant, Netherlands, 5591 VE
      • Recruiting
      • Kempenhaeghe - PPDS
  • North Holland
    • Heemstede, North Holland, Netherlands, 2103 SW
      • Recruiting
      • Slaap-Waakcentrum SEIN Heemstede
• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • University of Oslo
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron - PPDS
  • Madrid, Spain, 28036
    • Recruiting
    • Instituto de Investigaciones del Sueño
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Vithas Madrid Arturo Soria
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Recruiting
      • Hospital Universitario Araba Santiago
  • Castellon
    • Castellon, Castellon, Spain, 12004
      • Recruiting
      • Hospital General de Castello
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Recruiting
      • Hospital de La Ribera
• Sweden
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 46
      • Recruiting
      • Sahlgrenska University Hospital
• Switzerland
  • Bern, Switzerland, 43017-3521
    • Recruiting
    • Universitaetsspital Bern - Inselspital
  • Aargau (de)
    • Barmelweid, Aargau (de), Switzerland, 5017
      • Recruiting
      • Klinik Barmelweid AG
  • Ticino (it)
    • Lugano, Ticino (it), Switzerland, 6900
      • Recruiting
      • Neurocenter of Southern Switzerland
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Recruiting
      • Sleep Disorders Center of Alabama
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Center for Sleep Sciences and Medicine
    • Santa Ana, California, United States, 92705
      • Recruiting
      • SDS Clinical Trials, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • Delta Waves LLC - Hunt - PPDS
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Florida Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • NeuroTrials Research
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Georgia Neuro Center
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Recruiting
      • Neurocare Inc
  • Michigan
    • Novi, Michigan, United States, 48377
      • Recruiting
      • Henry Ford Medical Center - Columbus
  • North Carolina
    • Denver, North Carolina, United States, 28037
      • Recruiting
      • Research Carolina Elite
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • ARSM Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Recruiting
      • CTI Research Center
    • Cincinnati, Ohio, United States, 45227
      • Recruiting
      • Intrepid Research
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • The Cleveland Clinic Foundation
    • Dublin, Ohio, United States, 43017
      • Recruiting
      • Ohio Sleep Medicine Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina - PPDS
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • Bogan Sleep Consultants, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Sleep Therapy and Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Recruiting
      • Children's Specialty Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria:

1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
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) and aspartate aminotransferase (AST) values greater than (>) 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 (less than (<) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAK-861; In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.	Drug: TAK-861; TAK-861 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving trial intervention.	From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)	The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.	Baseline (parent trial), Week 26 (current LTE trial)
Change from Baseline in the Parent Trial in Epworth Sleepiness Scale (ESS) Total Score	The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.	Baseline (parent trial); Week 2 through Year 5 (current LTE trial)
Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary	Participants will record episodes of cataplexy in the diary throughout the trial.	Baseline (parent trial); Year 1 through Year 5 (current LTE trial)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: TAK-861-2003; U1111-1283-1888 (Other Identifier: WHO); jRCT2031230135 (Registry Identifier: jRCT); 2023-508462-15-00 (Ctis: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No