A Study of TAK-861 in Participants With Narcolepsy Type 2

Phase 2

Completed

Conditions: Narcolepsy Type 2

Interventions: Drug: Placebo
Drug: TAK-861 2 mg
Drug: TAK-861 2 mg and 5 mg

Registration Number: NCT05687916

Lead Sponsor: Takeda

Brief Summary: The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).

The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Detailed Description: The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy \[Narcolepsy Type 2 (NT2)\]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.

The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-861 Dose 1

* TAK-861 Dose 2

* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

Inclusion Criteria

The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).

Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.

The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.

Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

Exclusion Criteria

The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
The participant has one or more of the following psychiatric disorders:
1. Any current unstable psychiatric disorder.
2. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
3. Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
TAK-861 2 milligrams (mg) BID	TAK-861 2 mg	Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
TAK-861 2 mg and 5 mg	TAK-861 2 mg and 5 mg	Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8	Baseline, Week 8	The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8	Baseline, Week 8	The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. 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. The MMRM was used for analysis.
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)	From first dose of the study drug up to end of the study (up to 3 months)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, 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 was defined as an AE whose date of onset occurred on or after the first dose of study drug.

Trial Locations

Locations (56): SDS Clinical Trials, Inc.
🇺🇸
Santa Ana, California, United States
Ohio Sleep Medicine Institute
🇺🇸
Dublin, Ohio, United States
Stanford Center for Sleep Sciences and Medicine
🇺🇸
Redwood City, California, United States
Georgia Neuro Center
🇺🇸
Gainesville, Georgia, United States
St. Lukes Sleep Medicine and Research Center
🇺🇸
Chesterfield, Missouri, United States
Research Carolina Elite
🇺🇸
Denver, North Carolina, United States
Intrepid Research
🇺🇸
Cincinnati, Ohio, United States
Children's Specialty Group
🇺🇸
Norfolk, Virginia, United States
Woolcock Institute of Medical Research
🇦🇺
Glebe, New South Wales, Australia
Aichi Medical University Hospital
🇯🇵
Nagakute, Japan
Tricoastal Narcolepsy and Sleep Disorders Center, PLLC
🇺🇸
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Comprehensive Sleep Medicine Associates - Sugar Land
🇺🇸
Houston, Texas, United States
Hospital de La Ribera
🇪🇸
Alzira, Valencia, Spain
Istituto Neurologico Mediterraneo Neuromed
🇮🇹
Pozzilli, Molise, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹
Roma, Lazio, Italy
You Ariyoshi Sleep Clinic
🇯🇵
Kitakyushu-city, Hukuoka, Japan
Howakai Kuwamizu Hospital
🇯🇵
Kumamoto-Shi, Kumamoto, Japan
Slaap-Waakcentrum SEIN Heemstede
🇳🇱
Heemstede, Noord-Holland, Netherlands
Neurocenter of Southern Switzerland
🇨🇭
Lugano, Ticino (it), Switzerland
Kurume University Hospital
🇯🇵
Kurume-Shi, Hukuoka, Japan
Gokeikai Osaka Kaisei Hospital
🇯🇵
Osaka-Shi, Osaka, Japan
Mayo Clinic Arizona-PPDS
🇺🇸
Scottsdale, Arizona, United States
Akita University Hospital
🇯🇵
Akita-Shi, Akita, Japan
Kempenhaeghe - PPDS
🇳🇱
Heeze, Noord-Brabant, Netherlands
Medical University of South Carolina - PPDS
🇺🇸
Charleston, South Carolina, United States
Terveystalo Helsinki Sleep Clinic
🇫🇮
Helsinki, Uusimaa, Finland
Bogan Sleep Consultants, LLC
🇺🇸
Columbia, South Carolina, United States
National Center of Neurology and Psychiatry
🇯🇵
Kodaira-Shi, Tokyo, Japan
Ehime University Hospital
🇯🇵
Toon-Shi, Ehime, Japan
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪
Schwerin, Mecklenburg-Vorpommern, Germany
Oslo Universitetssykehus HF Rikshospitalet
🇳🇴
Oslo, Norway
Universitaetsspital Bern - Inselspital
🇨🇭
Bern, Switzerland
Yoyogi Sleep Disorder Center
🇯🇵
Shibuya-Ku, Tokyo, Japan
RESM respiratory and sleep medical-care clinic
🇯🇵
Yokohama, Japan
Klinik Barmelweid AG
🇨🇭
Barmelweid, Aargau (de), Switzerland
Instituto de Investigaciones del Sueno
🇪🇸
Madrid, Spain
Sleep Disorders Center of Alabama
🇺🇸
Birmingham, Alabama, United States
Sleep Therapy and Research Center
🇺🇸
San Antonio, Texas, United States
Florida Pediatric Research Institute
🇺🇸
Orlando, Florida, United States
Delta Waves LLC - Hunt - PPDS
🇺🇸
Colorado Springs, Colorado, United States
Neurotrials Research
🇺🇸
Atlanta, Georgia, United States
Henry Ford Medical Center - Columbus
🇺🇸
Novi, Michigan, United States
ARSM Research, LLC
🇺🇸
Huntersville, North Carolina, United States
Hopital Saint-Eloi
🇫🇷
Montpellier, Herault, France
Hopital de la Pitie Salpetriere
🇫🇷
Paris, France
CHU de Grenoble
🇫🇷
La Tronche, Isere, France
Advanced Sleep Research GmbH
🇩🇪
Berlin, Germany
IRCCS Istituto delle Scienze Neurologiche di Bologna
🇮🇹
Bellaria, Italy
Koishikawa Tokyo Hospital
🇯🇵
Bunkyo-Ku, Tokyo, Japan
Hospital Universitario Araba Santiago
🇪🇸
Vitoria-Gasteiz, Alava, Spain
Hospital General Universitari de Castello
🇪🇸
Castellón De La Plana, Castellon, Spain
Hospital Clinic de Barcelona
🇪🇸
Barcelona, Spain
Sahlgrenska Universitetssjukhuset
🇸🇪
Goteborg, Vastra Gotalands Lan, Sweden
Hospital Vithas Madrid Arturo Soria
🇪🇸
Madrid, Spain
Neurocare Inc.
🇺🇸
Newton, Massachusetts, United States