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A Study of TAK-994 in Adults With Narcolepsy

Sponsor
Takeda (Industry)
Overall Status
Terminated
CT.gov ID
NCT04820842
Collaborator
(none)
26
Enrollment
70
Locations
7
Arms
6.1
Actual Duration (Months)
0.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 30, 2021
Actual Primary Completion Date :
Nov 3, 2021
Actual Study Completion Date :
Nov 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Drug Extension Period: TAK-994 Dose 1

TAK-994 dose 1, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.

Drug: TAK-994
TAK-994 tablets.
Experimental: Active Drug Extension Period: TAK-994 Dose 2

TAK-994 dose 2, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.

Drug: TAK-994
TAK-994 tablets.
Experimental: Active Drug Extension Period: TAK-994 Dose 3

TAK-994 dose 3, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.

Drug: TAK-994
TAK-994 tablets.
Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 1

Following the Active Drug Extension Period, participants randomized to active treatment Dose 1 will continue to receive same dose (TAK-994, dose 1, tablets, orally) from Day 57 to Day 84.

Drug: TAK-994
TAK-994 tablets.
Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 2

Following the Active Drug Extension Period, participants randomized to active treatment Dose 2 will continue to receive same dose (TAK-994, dose 2, tablets, orally) from Day 57 to Day 84.

Drug: TAK-994
TAK-994 tablets.
Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 3

Following the Active Drug Extension Period, participants randomized to active treatment Dose 3 will continue to receive same dose (TAK-994, dose 3, tablets, orally) from Day 57 to Day 84.

Drug: TAK-994
TAK-994 tablets.
Placebo Comparator: Double-blind Randomized Withdrawal Period: Placebo

Following the Active Drug Extension Period participants will receive placebo-matching tablets for 4 weeks (from Day 57 to Day 84).

Drug: Placebo
Placebo-matching tablets.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period [Up to Week 8]

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participants 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 (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 is defined as an AE with an onset that occurs after receiving study drug.

  2. Number of Participants with at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period [Baseline up to Week 8]

    Markedly abnormal values for laboratory tests (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.

  3. Number of Participants with at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period [Baseline up to Week 8]

    Markedly abnormal values for vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.

  4. Number of Participants with at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period [Baseline up to Week 8]

    A 12 lead ECG will be performed and markedly abnormal values. will be collected as per pre-specified criteria.

Secondary Outcome Measures

  1. Number of Participants with at Least One TEAE During the Randomized Withdrawal Period of the Study [Weeks 8 to 14]

    An AE is defined as any untoward medical occurrence in a clinical investigation participants 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, 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 AE with an onset that occurs after receiving study drug.

  2. Number of Participants with at Least One Post-dose MAV for Laboratory Test During the Randomized Withdrawal Period [Weeks 8 to 14]

    Markedly abnormal values for laboratory tests for (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.

  3. Number of Participants with at Least One Post-dose MAV for Vital Signs During the Randomized Withdrawal Period [Weeks 8 to 14]

    Markedly abnormal values (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.

  4. Number of Participants with at Least One Post-dose MAV for ECG Parameters During the Randomized Withdrawal Period [Weeks 8 to 12]

    A 12 lead ECG will be performed and markedly abnormal values will be collected as per pre-specified criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wright Clinical Research Alabaster Alabama United States 35007
2 Mayo Clinic Arizona 300151190 Phoenix Arizona United States 85054
3 CITrials - Bellflower Bellflower California United States 90706
4 Santa Monica Clinical Trials Los Angeles California United States 90025
5 Stanford School of Medicine Redwood City California United States 94063
6 Pacific Research Network, Inc 150118105 San Diego California United States 92103
7 SDS Clinical Trials, Inc. Santa Ana California United States 92705
8 Alpine Clinical Research Center 1024762 Boulder Colorado United States 80301
9 Delta Waves Sleep Disorders and Research Center 300148510 Colorado Springs Colorado United States 80918
10 St. Francis Medical Institute Clearwater Florida United States 33765
11 Sleep Medicine Specialists of South Florida Miami Florida United States 33176
12 Clinical Site Partners, LLC Miami Florida United States 33186
13 JSV Clinical Research Study, Inc Tampa Florida United States 33624
14 Florida Pulmonary Research Institute, LLC 300127039 Winter Park Florida United States 32789
15 NeuroTrials Research, Inc. 300116336 Atlanta Georgia United States 30342
16 Sleep Practitioners, LLC Macon Macon Georgia United States 31210
17 Clinical Research Institute 300169881 Stockbridge Georgia United States 30281
18 Hawaii Pacific Neuroscience Honolulu Hawaii United States 96817
19 Fort Wayne Neurological Center 150711262 Fort Wayne Indiana United States 46804
20 University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital Kansas City Kansas United States 66160
21 Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420 Chevy Chase Maryland United States 20815
22 Beth Israel Deaconess Medical Center CardioVascular Institute Boston Massachusetts United States 02215
23 Research Carolina Elite Denver North Carolina United States 28037
24 Clinical Research of Gastonia Gastonia North Carolina United States 28054
25 Raleigh Neurology Associates 300209729 Raleigh North Carolina United States 27607
26 Raleigh Neurology Associates,300209729 Raleigh North Carolina United States 27607
27 CTI Clinical Research Center Cincinnati Ohio United States 45245
28 Intrepid Research Cincinnati Ohio United States 45245
29 The Cleveland Clinic Foundation 100428 Cleveland Ohio United States 44195
30 Ohio Sleep Medicine and Neuroscience Institute 186 Dublin Ohio United States 43017
31 Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd Wyomissing Pennsylvania United States 19610
32 Medical University of South Carolina (MUSC) PARENT Charleston South Carolina United States 29425
33 Bogan Sleep Consultants, LLC 150711087 Columbia South Carolina United States 29201
34 Sleep Therapy & Research Center 300151246 San Antonio Texas United States 78229
35 Comprehensive Sleep Medicine Associates Sugar Land Texas United States 77478
36 West Ottawa Sleep Centre Ottawa Ontario Canada K2A 3Z3
37 Toronto Sleep Institute Toronto Ontario Canada M4P 1P2
38 Jodha Tishon Inc. Toronto Ontario Canada M5S 3A3
39 Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika Hradec Kralove Czechia 50005
40 Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze Praha 2 Czechia 128 21
41 Terveystalo Helsinki Uniklinikka 300186257 Helsinki Finland 00380
42 Turku University Hospital Turku Finland 20521
43 Hopital Gui de Chauliac Service de Neurologie Montpellier Herault France 34295
44 Hopital Roger Salengro - CHU Lille service de neurologie D Lille Cedex Nord France 59037
45 SomnoCenter Budapest Budapest Hungary 1012
46 IRCCS Oasi Maria SS 300206751 Troina Enna Italy 94018
47 Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Bologna Italy 40123
48 Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno Milano Italy 20127
49 Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia Roma Italy 00133
50 SOUSEIKAI PS Clinic Dept of Internal Medicine Fukuoka-shi Fukuoka-Ken Japan 812-0025
51 You Ariyoshi Sleep Clinic Dept of Psychiatry Kitakyushu-shi Fukuoka-Ken Japan 802-0084
52 Kurume University Hospital Dept of Neuropsychiatry Kurume-shi Fukuoka-Ken Japan 830-0011
53 Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine Yokohama-shi Kanagawa-Ken Japan 223-0059
54 Howakai Kuwamizu Hospital Dept of Internal Medicine Kumamoto-shi Kumamoto-Ken Japan 862-0954
55 Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry Isahaya-shi Nagasaki-Ken Japan 854-0081
56 Shunkaikai Inoue Hospital Dept of Respiratory Medicine Nagasaki-shi Nagasaki-Ken Japan 850-0045
57 Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine Osaka-shi Osaka-Fu Japan 532-0003
58 Kyowakai Hannan Hospital Dept of Psychiatry Sakai-shi Osaka-Fu Japan 599-8263
59 Koishikawa Tokyo Hospital Dept of Psychiatry Bunkyo-ku Tokyo-To Japan 112-0012
60 Nihon University Itabashi Hospital Dept of Neuropsychiatry Itabashi-ku Tokyo-To Japan 173-8610
61 Yoyogi Sleep Disorder Center Dept of Psychiatry Shibuya-ku Tokyo-To Japan 151-0053
62 Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry Shinagawa-ku Tokyo-To Japan 140-0011
63 Sleep & Stress Clinic Dept of Psychiatry Shinagawa-ku Tokyo-To Japan 141-6003
64 Sumida Hospital Phase I Sumida-ku Tokyo-To Japan 130-0004
65 The Catholic University of Korea, St. Vincent's Hospital 300187879 Suwon-si Gyeonggi-do Korea, Republic of 16247
66 Keimyung University Dongsan Hospital 300144594 Daegu Korea, Republic of 42601
67 Hospital Universitario Araba Sede Santiago Sleep Unit Vitoria Alava Spain 01004
68 Hospital General de Castellon Servicio de Neurofisiologia Castellon de la Plana Castellon Spain 12004
69 Hospital Clinic de Barcelona Servicio de Neurologia Barcelona Spain 08036
70 Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica Madrid Spain 28043

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT04820842
Other Study ID Numbers:
  • TAK-994-1504
  • 2021-000251-39
First Posted:
Mar 29, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeda
Drug Therapy
Additional relevant MeSH terms:
Narcolepsy

Study Results

No Results Posted as of Dec 7, 2021