Clinical trial NCT05816382: A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Official title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Narcolepsy Type 1
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 500
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 safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Detailed description: The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This study 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 study was initiated in parallel with the parent phase 2 studies, 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) study enrolled participants with both diagnoses from the two phase 2 studies. As the TAK-861-2002 study did not meet prespecified criteria, all participants with NT2 have been discontinued, and this extension study will only include participants with NT1 who previously completed a parent study. Additional parent studies include all TAK-861 phase 3 studies.

The study will enroll up to 500 patients. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.

Participants with NT1 will receive the following dose from the parent study:

* TAK-861 Dose 1
* TAK-861 Dose 2

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to approximately 5 years. 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 study drug.

Eligibility criteria: Inclusion 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.

Exclusion criteria:

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.

Primary outcomes:
measure: Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
Secondary outcomes:
measure: Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
timeFrame: Baseline (parent study), Week 26 (current LTE study)
measure: Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score
timeFrame: Baseline (parent study); Week 2 through Year 5 (current LTE study)
measure: Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary
timeFrame: Baseline (parent study); Year 1 through Year 5 (current LTE study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
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: 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: CTI Research Center
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: 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: Toulouse
country: France
facility: Hopital Pierre-Paul Riquet
state: Haute-Garonne
city: Montpellier
country: France
facility: CHU Gui De Chauliac
state: Herault
city: La Tronche
country: France
facility: CHU de Grenoble
state: Isere
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Regensburg
country: Germany
facility: Universitaet Regensburg am Bezirksklinikum
state: Bayern
city: Schwerin
country: Germany
facility: Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
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: Ospedale Bellaria
city: Kurume-Shi
country: Japan
facility: Kurume University Hospital
state: Hukuoka
city: Kumamoto-Shi
country: Japan
facility: Howakai Kuwamizu Hospital
state: Kumamoto
city: Nagasaki-Shi
country: Japan
facility: YOU ARIYOSHI Sleep Clinic
state: Nagasaki
city: Osaka-Shi
country: Japan
facility: Gokeikai Osaka Kaisei Hospital
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Koishikawa Tokyo Hospital
state: Tokyo
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
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: University of Oslo
city: Vitoria
country: Spain
facility: Hospital Universitario Araba Santiago
state: Alava
city: Castellón De La Plana
country: Spain
facility: Hospital General de Castello
state: Castellon
city: Alzira
country: Spain
facility: Hospital de La Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
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 University Hospital
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: Study Director
role: STUDY_DIRECTOR
References: