Clinical trial NCT04820842: A Study of TAK-994 in Adults With Narcolepsy
Official title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Narcolepsy Type 1 (NT 1)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

Detailed description: The drug being tested in the study is called TAK-994. TAK-994, is being tested to treat participants with NT1. Participants who completed Part B of TAK-994-1501(NCT04096560) will be eligible for enrollment in this study.

This study will enroll approximately 112 patients to receive one of three different TAK 994 dose for 8 weeks (active drug extension period). Participants will be randomly assigned to one of these different TAK 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Following the 8-week Active Drug Extension Period, participants will continue into a 4-week Double-blind Randomized Withdrawal Period and will receive TAK-994 or Placebo.

Participants randomized to TAK-994 will continue to receive the same dose as before.

This multi-center trial will be conducted worldwide. The duration of treatment in this study is 12 weeks plus a 2 week safety follow up period. Participants will visit the clinic 10 times after the first dosing.

Eligibility criteria: Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.

Primary outcomes:
measure: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period
timeFrame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)
measure: Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
timeFrame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)
measure: Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
timeFrame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)
measure: Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
timeFrame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)
Secondary outcomes:
measure: Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period
timeFrame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)
measure: Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period
timeFrame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)
measure: Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period
timeFrame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)
measure: Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period
timeFrame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Wright Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona 300151190
state: Arizona
city: Bellflower
country: United States
facility: CITrials - Bellflower
state: California
city: Los Angeles
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Redwood City
country: United States
facility: Stanford School of Medicine
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc 150118105
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center 1024762
state: Colorado
city: Colorado Springs
country: United States
facility: Delta Waves Sleep Disorders and Research Center 300148510
state: Colorado
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research Study, Inc
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC 300127039
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc. 300116336
state: Georgia
city: Macon
country: United States
facility: Sleep Practitioners, LLC Macon
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute 300169881
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center 150711262
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital
state: Kansas
city: Chevy Chase
country: United States
facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center CardioVascular Institute
state: Massachusetts
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates 300209729
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates,300209729
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation 100428
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine and Neuroscience Institute 186
state: Ohio
city: Wyomissing
country: United States
facility: Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC) PARENT
state: South Carolina
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC 150711087
state: South Carolina
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center 300151246
state: Texas
city: Sugar Land
country: United States
facility: Comprehensive Sleep Medicine Associates
state: Texas
city: Ottawa
country: Canada
facility: West Ottawa Sleep Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sleep Institute
state: Ontario
city: Toronto
country: Canada
facility: Jodha Tishon Inc.
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze
city: Helsinki
country: Finland
facility: Terveystalo Helsinki Uniklinikka 300186257
city: Turku
country: Finland
facility: Turku University Hospital
city: Montpellier
country: France
facility: Hopital Gui de Chauliac Service de Neurologie
state: Herault
city: Lille Cedex
country: France
facility: Hopital Roger Salengro - CHU Lille service de neurologie D
state: Nord
city: Budapest
country: Hungary
facility: SomnoCenter Budapest
city: Troina
country: Italy
facility: IRCCS Oasi Maria SS 300206751
state: Enna
city: Bologna
country: Italy
facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
city: Milano
country: Italy
facility: Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia
city: Fukuoka-shi
country: Japan
facility: SOUSEIKAI PS Clinic Dept of Internal Medicine
state: Fukuoka-Ken
city: Kitakyushu-shi
country: Japan
facility: You Ariyoshi Sleep Clinic Dept of Psychiatry
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital Dept of Neuropsychiatry
state: Fukuoka-Ken
city: Yokohama-shi
country: Japan
facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Howakai Kuwamizu Hospital Dept of Internal Medicine
state: Kumamoto-Ken
city: Isahaya-shi
country: Japan
facility: Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry
state: Nagasaki-Ken
city: Nagasaki-shi
country: Japan
facility: Shunkaikai Inoue Hospital Dept of Respiratory Medicine
state: Nagasaki-Ken
city: Osaka-shi
country: Japan
facility: Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine
state: Osaka-Fu
city: Sakai-shi
country: Japan
facility: Kyowakai Hannan Hospital Dept of Psychiatry
state: Osaka-Fu
city: Bunkyo-ku
country: Japan
facility: Koishikawa Tokyo Hospital Dept of Psychiatry
state: Tokyo-To
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital Dept of Neuropsychiatry
state: Tokyo-To
city: Shibuya-ku
country: Japan
facility: Yoyogi Sleep Disorder Center Dept of Psychiatry
state: Tokyo-To
city: Shinagawa-ku
country: Japan
facility: Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry
state: Tokyo-To
city: Shinagawa-ku
country: Japan
facility: Sleep & Stress Clinic Dept of Psychiatry
state: Tokyo-To
city: Sumida-ku
country: Japan
facility: Sumida Hospital Phase I
state: Tokyo-To
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital 300187879
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital 300144594
city: Vitoria
country: Spain
facility: Hospital Universitario Araba Sede Santiago Sleep Unit
state: Alava
city: Castellon de la Plana
country: Spain
facility: Hospital General de Castellon Servicio de Neurofisiologia
state: Castellon
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: