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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000251-39 | EudraCT Number |
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A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drug Extension Period: TAK-994 30 mg | Experimental | TAK-994 30 mg, twice daily (BID) tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
|
| Active Drug Extension Period: TAK-994 90 mg | Experimental | TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
|
| Active Drug Extension Period: TAK-994 180 mg | Experimental | TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
|
| Double-blind Randomized Withdrawal Period: TAK-994 30 mg | Experimental | Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
|
| Double-blind Randomized Withdrawal Period: TAK-994 90 mg | Experimental | Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-994 | Drug | TAK-994 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period | 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. | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period | Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin <0.8×lower limit of normal (LLN), >1.2×upper limit of normal (ULN); Hematocrit <0.8×LLN, >1.2×ULN; Red blood cells (RBC) count <0.8×LLN, >1.2×ULN; White blood cells (WBC) count <0.5xLLN, >1.5xULN; Platelet count <75x10^9/liter (L), >600x10^9/L; alanine aminotransferase (ALT) >3xULN; aspartate aminotransferase (AST) >3xULN; gamma-glutamyl transferase (GGT) >3xULN; Alkaline phosphatase >3xULN; Total bilirubin >1.5xULN; Albumin <25 grams per liter (g/L); Total protein <0.8xLLN, >1.2xULN; Creatinine >1.5xULN; Blood urea nitrogen >40 milligrams per deciliters (mg/dL); Sodium <130 milliequivalents per liter (mEq/L), >150 mEq/L; Potassium <3.0 millimoles per liter (mmol/L), >5.3 mmol/L; creatine phosphokinase (CPK) >3xULN; Glucose <50 mg/dL, >300 mg/dL; Calcium <7.7 mg/dL, >11.1 mg/dL. Only categories with at least one participant with event are reported. | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period | MAV criteria for vital signs were: Pulse <40 beats per minute (bpm), >115 bpm; Systolic blood pressure <90 millimeters of mercury (mmHg), ≥160 mmHg; Diastolic blood pressure <50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of >20, >30 mmHg from Baseline, Body temperature >38.5 degree Celsius, Respiratory Rate >21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Active Drug Extension Period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period | 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 (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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright Clinical Research | Alabaster | Alabama | 35007 | United States | ||
| Mayo Clinic Arizona 300151190 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37494485 | Derived | Dauvilliers Y, Mignot E, Del Rio Villegas R, Du Y, Hanson E, Inoue Y, Kadali H, Koundourakis E, Meyer S, Rogers R, Scammell TE, Sheikh SI, Swick T, Szakacs Z, von Rosenstiel P, Wu J, Zeitz H, Murthy NV, Plazzi G, von Hehn C. Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1. N Engl J Med. 2023 Jul 27;389(4):309-321. doi: 10.1056/NEJMoa2301940. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https:// clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/ takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with narcolepsy type 1 (NT 1) who completed Part B of TAK-994-1501(NCT04096560) were enrolled in this study to receive TAK-994 or placebo.
Participants took part in the study at 13 investigative sites in Spain, Italy, Japan, Korea, and the United States from 30 April 2021 to 03 November 2021 [early termination date].
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug Extension Period: TAK-994 30 mg | TAK-994 30 mg, twice daily (BID) tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| FG001 | Active Drug Extension Period: TAK-994 90 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Active Drug Extension Period (8 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Nov 3, 2023 |
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|
| Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Experimental | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
|
| Double-blind Randomized Withdrawal Period: Placebo | Placebo Comparator | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
|
| Placebo | Drug | Placebo-matching tablets. |
|
| Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period | MAV criteria for ECG were: Heart rate <40 bpm, >115 bpm; PR interval ≤80 milliseconds (msec), ≥200 msec; QT interval with Fridericia correction method (QTcF) Interval ≤300 msec, >500 msec or ≥30 msec change from baseline and >450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported. | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
| Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period | Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin <0.8×LLN, >1.2×ULN; Hematocrit <0.8×LLN, >1.2×ULN; RBC count <0.8×LLN, >1.2×ULN; WBC count <0.5xLLN, >1.5xULN; Platelet count <75x10^9/L, >600x10^9/L; ALT >3xULN; AST >3xULN; GGT >3xULN; Alkaline phosphatase >3xULN; Total bilirubin >1.5xULN; Albumin <25 g/L; Total protein <0.8x LLN, >1.2xULN; Creatinine >1.5xULN; Blood urea nitrogen >40 mg/dL; Sodium <130 mEq/L, >150 mEq/L; Potassium <3.0 mmol/L, >5.3 mmol/L; CPK >3xULN; Glucose <50 mg/dL, >300 mg/dL; Calcium <7.7 mg/dL, >11.1 mg/dL. | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
| Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period | MAV criteria for vital signs were: Pulse <40 bpm, >115 bpm; Systolic blood pressure <90 mmHg, ≥160 mmHg; Diastolic blood pressure <50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of >20, >30 mmHg from Baseline, Body temperature >38.5 degree Celsius, Respiratory Rate >21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Double-blind Randomized Withdrawal Period (Day 57 of this study). | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
| Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period | MAV criteria for ECG were: Heart rate <40 bpm, >115 bpm; PR interval ≤80 msec, ≥200 msec; QTcF Interval ≤300 msec, >500 msec or ≥30 msec change from baseline and >450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported. | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| CITrials - Bellflower | Bellflower | California | 90706 | United States |
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | United States |
| Stanford School of Medicine | Redwood City | California | 94063 | United States |
| Pacific Research Network, Inc 150118105 | San Diego | California | 92103 | United States |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | United States |
| Alpine Clinical Research Center 1024762 | Boulder | Colorado | 80301 | United States |
| Delta Waves Sleep Disorders and Research Center 300148510 | Colorado Springs | Colorado | 80918 | United States |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | United States |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33176 | United States |
| Clinical Site Partners, LLC | Miami | Florida | 33186 | United States |
| JSV Clinical Research Study, Inc | Tampa | Florida | 33624 | United States |
| Florida Pulmonary Research Institute, LLC 300127039 | Winter Park | Florida | 32789 | United States |
| NeuroTrials Research, Inc. 300116336 | Atlanta | Georgia | 30342 | United States |
| Sleep Practitioners, LLC Macon | Macon | Georgia | 31210 | United States |
| Clinical Research Institute 300169881 | Stockbridge | Georgia | 30281 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Fort Wayne Neurological Center 150711262 | Fort Wayne | Indiana | 46804 | United States |
| University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420 | Chevy Chase | Maryland | 20815 | United States |
| Beth Israel Deaconess Medical Center CardioVascular Institute | Boston | Massachusetts | 02215 | United States |
| Research Carolina Elite | Denver | North Carolina | 28037 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Raleigh Neurology Associates 300209729 | Raleigh | North Carolina | 27607 | United States |
| Raleigh Neurology Associates,300209729 | Raleigh | North Carolina | 27607 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45245 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| The Cleveland Clinic Foundation 100428 | Cleveland | Ohio | 44195 | United States |
| Ohio Sleep Medicine and Neuroscience Institute 186 | Dublin | Ohio | 43017 | United States |
| Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd | Wyomissing | Pennsylvania | 19610 | United States |
| Medical University of South Carolina (MUSC) PARENT | Charleston | South Carolina | 29425 | United States |
| Bogan Sleep Consultants, LLC 150711087 | Columbia | South Carolina | 29201 | United States |
| Sleep Therapy & Research Center 300151246 | San Antonio | Texas | 78229 | United States |
| Comprehensive Sleep Medicine Associates | Sugar Land | Texas | 77478 | United States |
| West Ottawa Sleep Centre | Ottawa | Ontario | K2A 3Z3 | Canada |
| Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
| Jodha Tishon Inc. | Toronto | Ontario | M5S 3A3 | Canada |
| Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika | Hradec Králové | 50005 | Czechia |
| Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze | Prague | 128 21 | Czechia |
| Terveystalo Helsinki Uniklinikka 300186257 | Helsinki | 00380 | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| Hopital Gui de Chauliac Service de Neurologie | Montpellier | Herault | 34295 | France |
| Hopital Roger Salengro - CHU Lille service de neurologie D | Lille | Nord | 59037 | France |
| SomnoCenter Budapest | Budapest | 1012 | Hungary |
| IRCCS Oasi Maria SS 300206751 | Troina | Enna | 94018 | Italy |
| Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche | Bologna | 40123 | Italy |
| Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno | Milan | 20127 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia | Roma | 00133 | Italy |
| SOUSEIKAI PS Clinic Dept of Internal Medicine | Fukuoka | Fukuoka | 812-0025 | Japan |
| You Ariyoshi Sleep Clinic Dept of Psychiatry | Kitakyushu-shi | Fukuoka | 802-0084 | Japan |
| Kurume University Hospital Dept of Neuropsychiatry | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine | Yokohama | Kanagawa | 223-0059 | Japan |
| Howakai Kuwamizu Hospital Dept of Internal Medicine | Kumamoto | Kumamoto | 862-0954 | Japan |
| Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry | Isahaya-shi | Nagasaki | 854-0081 | Japan |
| Shunkaikai Inoue Hospital Dept of Respiratory Medicine | Nagasaki | Nagasaki | 850-0045 | Japan |
| Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine | Osaka | Osaka | 532-0003 | Japan |
| Kyowakai Hannan Hospital Dept of Psychiatry | Sakai-shi | Osaka | 599-8263 | Japan |
| Koishikawa Tokyo Hospital Dept of Psychiatry | Bunkyō City | Tokyo-To | 112-0012 | Japan |
| Nihon University Itabashi Hospital Dept of Neuropsychiatry | Itabashi-ku | Tokyo-To | 173-8610 | Japan |
| Yoyogi Sleep Disorder Center Dept of Psychiatry | Shibuya-ku | Tokyo-To | 151-0053 | Japan |
| Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry | Shinagawa-ku | Tokyo-To | 140-0011 | Japan |
| Sleep & Stress Clinic Dept of Psychiatry | Shinagawa-ku | Tokyo-To | 141-6003 | Japan |
| Sumida Hospital Phase I | Sumida-ku | Tokyo-To | 130-0004 | Japan |
| The Catholic University of Korea, St. Vincent's Hospital 300187879 | Suwon | Gyeonggi-do | 16247 | South Korea |
| Keimyung University Dongsan Hospital 300144594 | Daegu | 42601 | South Korea |
| Hospital Universitario Araba Sede Santiago Sleep Unit | Vitoria-Gasteiz | Alava | 01004 | Spain |
| Hospital General de Castellon Servicio de Neurofisiologia | Castellon | Castellon | 12004 | Spain |
| Hospital Clinic de Barcelona Servicio de Neurologia | Barcelona | 08036 | Spain |
| Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica | Madrid | 28043 | Spain |
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
| FG002 | Active Drug Extension Period: TAK-994 180 mg | TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| FG003 | Double-blind Randomized Withdrawal Period: TAK-994 30 mg | Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| FG004 | Double-blind Randomized Withdrawal Period: TAK-994 90 mg | Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| FG005 | Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| FG006 | Double-blind Randomized Withdrawal Period: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized Withdrawal Period (4 Weeks) |
|
|
Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug Extension Period: TAK-994 30 mg | TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| BG001 | Active Drug Extension Period: TAK-994 90 mg | TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| BG002 | Active Drug Extension Period: TAK-994 180 mg | TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
| |||||||||||||||
| Body Mass Index (BMI) | BMI=weight (kg) / [height (m)]^2 | Mean | Standard Deviation | kilograms per meter square (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period | 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. | Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period. | Posted | Count of Participants | Participants | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period | Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin <0.8×lower limit of normal (LLN), >1.2×upper limit of normal (ULN); Hematocrit <0.8×LLN, >1.2×ULN; Red blood cells (RBC) count <0.8×LLN, >1.2×ULN; White blood cells (WBC) count <0.5xLLN, >1.5xULN; Platelet count <75x10^9/liter (L), >600x10^9/L; alanine aminotransferase (ALT) >3xULN; aspartate aminotransferase (AST) >3xULN; gamma-glutamyl transferase (GGT) >3xULN; Alkaline phosphatase >3xULN; Total bilirubin >1.5xULN; Albumin <25 grams per liter (g/L); Total protein <0.8xLLN, >1.2xULN; Creatinine >1.5xULN; Blood urea nitrogen >40 milligrams per deciliters (mg/dL); Sodium <130 milliequivalents per liter (mEq/L), >150 mEq/L; Potassium <3.0 millimoles per liter (mmol/L), >5.3 mmol/L; creatine phosphokinase (CPK) >3xULN; Glucose <50 mg/dL, >300 mg/dL; Calcium <7.7 mg/dL, >11.1 mg/dL. Only categories with at least one participant with event are reported. | Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period. | Posted | Count of Participants | Participants | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period | MAV criteria for vital signs were: Pulse <40 beats per minute (bpm), >115 bpm; Systolic blood pressure <90 millimeters of mercury (mmHg), ≥160 mmHg; Diastolic blood pressure <50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of >20, >30 mmHg from Baseline, Body temperature >38.5 degree Celsius, Respiratory Rate >21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Active Drug Extension Period. | Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period. | Posted | Count of Participants | Participants | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
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| Primary | Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period | MAV criteria for ECG were: Heart rate <40 bpm, >115 bpm; PR interval ≤80 milliseconds (msec), ≥200 msec; QT interval with Fridericia correction method (QTcF) Interval ≤300 msec, >500 msec or ≥30 msec change from baseline and >450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported. | Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period. | Posted | Count of Participants | Participants | Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period | 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 (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. | Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period. | Posted | Count of Participants | Participants | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
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| Secondary | Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period | Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin <0.8×LLN, >1.2×ULN; Hematocrit <0.8×LLN, >1.2×ULN; RBC count <0.8×LLN, >1.2×ULN; WBC count <0.5xLLN, >1.5xULN; Platelet count <75x10^9/L, >600x10^9/L; ALT >3xULN; AST >3xULN; GGT >3xULN; Alkaline phosphatase >3xULN; Total bilirubin >1.5xULN; Albumin <25 g/L; Total protein <0.8x LLN, >1.2xULN; Creatinine >1.5xULN; Blood urea nitrogen >40 mg/dL; Sodium <130 mEq/L, >150 mEq/L; Potassium <3.0 mmol/L, >5.3 mmol/L; CPK >3xULN; Glucose <50 mg/dL, >300 mg/dL; Calcium <7.7 mg/dL, >11.1 mg/dL. | Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period. | Posted | Count of Participants | Participants | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
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| Secondary | Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period | MAV criteria for vital signs were: Pulse <40 bpm, >115 bpm; Systolic blood pressure <90 mmHg, ≥160 mmHg; Diastolic blood pressure <50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of >20, >30 mmHg from Baseline, Body temperature >38.5 degree Celsius, Respiratory Rate >21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Double-blind Randomized Withdrawal Period (Day 57 of this study). | Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period. | Posted | Count of Participants | Participants | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
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| Secondary | Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period | MAV criteria for ECG were: Heart rate <40 bpm, >115 bpm; PR interval ≤80 msec, ≥200 msec; QTcF Interval ≤300 msec, >500 msec or ≥30 msec change from baseline and >450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported. | Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period. | Posted | Count of Participants | Participants | Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12) |
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From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: TAK-994 30 mg BID | TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG001 | Period 1: TAK-994 90 mg BID | TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. | 0 | 9 | 1 | 9 | 4 | 9 |
| EG002 | Period 1: TAK-994 180 mg BID | TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. | 0 | 9 | 1 | 9 | 3 | 9 |
| EG003 | Period 2: TAK-994 30 mg BID | Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Period 2: TAK-994 90 mg BID | Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Period 2: TAK-994 180 mg BID | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | Period 2: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. | 0 | 3 | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 24 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 24 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 24 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 24 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Temperature intolerance | General disorders | MedDRA 24 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2021 | Nov 3, 2023 | SAP_001.pdf |
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Italy |
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| Japan |
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| Korea, South |
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| United States |
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| OG001 |
| Active Drug Extension Period: TAK-994 90 mg |
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
| OG002 | Active Drug Extension Period: TAK-994 180 mg | TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
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TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. |
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| OG002 | Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| OG003 | Double-blind Randomized Withdrawal Period: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
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|
Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| OG002 | Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| OG003 | Double-blind Randomized Withdrawal Period: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
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| OG002 | Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| OG003 | Double-blind Randomized Withdrawal Period: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
|
|
| OG002 | Double-blind Randomized Withdrawal Period: TAK-994 180 mg | Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period. |
| OG003 | Double-blind Randomized Withdrawal Period: Placebo | Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period. |
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