Clinical trial NCT05687916: A Study of TAK-861 in Participants With Narcolepsy Type 2
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy Type 2
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 71
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
timeFrame: Baseline, Week 8
measure: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: From first dose of the study drug up to end of the study (up to 3 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona-PPDS
state: Arizona
city: Redwood City
country: United States
facility: Stanford Center for Sleep Sciences and Medicine
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Colorado Springs
country: United States
facility: Delta Waves LLC - Hunt - PPDS
state: Colorado
city: Orlando
country: United States
facility: Florida Pediatric Research Institute
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research
state: Georgia
city: Gainesville
country: United States
facility: Georgia Neuro Center
state: Georgia
city: Newton
country: United States
facility: Neurocare Inc.
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Medical Center - Columbus
state: Michigan
city: Chesterfield
country: United States
facility: St. Lukes Sleep Medicine and Research Center
state: Missouri
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Huntersville
country: United States
facility: ARSM Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Tricoastal Narcolepsy and Sleep Disorders Center, PLLC
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina - PPDS
state: South Carolina
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Houston
country: United States
facility: Comprehensive Sleep Medicine Associates - Sugar Land
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
city: Norfolk
country: United States
facility: Children's Specialty Group
state: Virginia
city: Glebe
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
city: Helsinki
country: Finland
facility: Terveystalo Helsinki Sleep Clinic
state: Uusimaa
city: Montpellier
country: France
facility: Hopital Saint-Eloi
state: Herault
city: La Tronche
country: France
facility: CHU de Grenoble
state: Isere
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Schwerin
country: Germany
facility: Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: Advanced Sleep Research GmbH
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Pozzilli
country: Italy
facility: Istituto Neurologico Mediterraneo Neuromed
state: Molise
city: Bellaria
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
city: Akita-Shi
country: Japan
facility: Akita University Hospital
state: Akita
city: Toon-Shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kitakyushu-city
country: Japan
facility: You Ariyoshi Sleep Clinic
state: Hukuoka
city: Kurume-Shi
country: Japan
facility: Kurume University Hospital
state: Hukuoka
city: Kumamoto-Shi
country: Japan
facility: Howakai Kuwamizu Hospital
state: Kumamoto
city: Osaka-Shi
country: Japan
facility: Gokeikai Osaka Kaisei Hospital
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Koishikawa Tokyo Hospital
state: Tokyo
city: Kodaira-Shi
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
city: Shibuya-Ku
country: Japan
facility: Yoyogi Sleep Disorder Center
state: Tokyo
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Yokohama
country: Japan
facility: RESM respiratory and sleep medical-care clinic
city: Heeze
country: Netherlands
facility: Kempenhaeghe - PPDS
state: Noord-Brabant
city: Heemstede
country: Netherlands
facility: Slaap-Waakcentrum SEIN Heemstede
state: Noord-Holland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF Rikshospitalet
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba Santiago
state: Alava
city: Castellón De La Plana
country: Spain
facility: Hospital General Universitari de Castello
state: Castellon
city: Alzira
country: Spain
facility: Hospital de La Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Madrid
country: Spain
facility: Hospital Vithas Madrid Arturo Soria
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Vastra Gotalands Lan
city: Barmelweid
country: Switzerland
facility: Klinik Barmelweid AG
state: Aargau (de)
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland
state: Ticino (it)
city: Bern
country: Switzerland
facility: Universitaetsspital Bern - Inselspital
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: