chufangao/CTO huggingface dataset:
Clinical trial NCT02999906: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
Sponsor: United Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: For business reasons.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-31
Primary completion date: 2021-12-31
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT04325061: Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19
Official title: Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19
Acronym: DEXA-COVID19
Sponsor: Dr. Negrin University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-03
Primary completion date: 2020-06-19
Completion date: 2020-06-19
Plan to share individual participant data: NO
Clinical trial NCT04546828: A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea
Official title: A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in Korea
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: problem of sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-01
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Clinical trial NCT04303572: The Hemophilia Inhibitor Eradication Trial
Official title: Phase III Multi-Center, Randomized, Controlled Inhibitor Eradication Trial, Comparing Eloctate Immune Tolerance Induction (ITI) Plus Emicizumab vs. Eloctate ITI Alone to Eradicate Inhibitor Formation in Severe Hemophilia A
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-01
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: YES
IPD sharing description: A biologic specimen and data repository for this trial will be available at the Graduate School of Public Health (GSPH) Data Center repository for investigators who make formal application request and is formally approved by the Coordinating Center (Pitt) and Data Center (GSPH).
IPD time frame: Within one year of trial completion.
IPD access criteria: Access will be determined by the Study Team.
Clinical trial NCT03902509: A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Official title: A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The protocol revision is needed.
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-24
Primary completion date: 2022-06-13
Completion date: 2022-06-13
Plan to share individual participant data: NO
Clinical trial NCT03127345: Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health
Official title: Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2023-09-30
Completion date: 2023-09-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05303909: The Immunostimulatory Effects of Gentamicin
Official title: The Immunostimulatory Effects of Gentamicin: Translating Aminoglycoside Antibiotics Into Antiviral Therapeutics for Pandemic Response (Part B)
Sponsor: Singapore General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: slow recruitment due to COVID19
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-11
Primary completion date: 2024-05-13
Completion date: 2024-05-13
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04633447: A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Official title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Acronym: THEIA
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study primary endpoint was not met.
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-10
Primary completion date: 2024-05-22
Completion date: 2024-05-22
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04294277: Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery
Official title: Open-label, Single-arm, Phase II Study, Evaluating Safety and Efficacy of INCB054828 (Pemigatinib) as Adjuvant Therapy for Molecularly-selected, High-risk Patients With Urothelial Carcinoma Who Have Received Radical Surgery
Acronym: PEGASUS
Sponsor: European Association of Urology Research Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Screening success and patient recruitment was much lower than projected and a clinical/scientific interpretation will not be possible.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-13
Primary completion date: 2021-11-15
Completion date: 2022-11-15
Clinical trial NCT05413902: Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
Official title: Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
Sponsor: University of Puerto Rico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-05
Primary completion date: 2022-01-28
Completion date: 2022-03-23
Plan to share individual participant data: NO
IPD sharing description: There is no plan to make individual participant data (IPD) available to other researchers. However, data could be shared upon individual researchers' reasonable request.
Clinical trial NCT04004325: A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-17
Primary completion date: 2020-01-20
Completion date: 2020-01-20
Clinical trial NCT03924245: Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers
Official title: A Phase I/II Study of Olaparib With Entinostat in the Treatment of Recurrent, Platinum-Refractory or Resistant, Homologous Recombination Repair Proficient Ovarian, Primary Peritoneal, and Fallopian Tube Cancers
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Change in participant landscape and other treatment availability
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-01
Primary completion date: 2022-02-04
Completion date: 2022-02-04
Plan to share individual participant data: NO
Clinical trial NCT03805178: Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization
Official title: Lung Transplant Plasmapheresis (PLEX)/Belatacept/Carfilzomib Protocol for Treatment of Antibody Mediated Rejection (AMR) and Desensitization
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Not activated at Duke
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2020-08-01
Completion date: 2020-10-30
Plan to share individual participant data: NO
Clinical trial NCT04385264: #StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
Official title: #StayHome: Efficacy of Early Hydroxychloroquine in Outpatients to Reduce Secondary Hospitalisation and Household Transmission of COVID-19 in Switzerland: A Double-blind, Randomised, Placebo-controlled Trial
Acronym: #StayHome
Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: Sufficient number of subjects would probably not reach
Enrollment: 800.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2022-01-31
Primary completion date: 2022-08-31
Completion date: 2022-12-31
Plan to share individual participant data: YES
IPD sharing description: The aim is to share data, protocols, information sheets, CRFs and analytical code as soon as possible. Data will first be cleaned and anonymised and then subjected to rigorous assessments to secure patient privacy and analytical robustness according to the FAIR principles.
IPD time frame: Unknown (determined by the evolution of the epidemic)
IPD access criteria: On request by researchers agreeing to use the data for it intended purpose: i.e. to further knowledge of the efficacy and safety of HCQ in COVID-19 and to better understand the disease.
Clinical trial NCT03105128: A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 931.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-05-10
Primary completion date: 2020-11-09
Completion date: 2021-04-14
Baseline population: Consists of all subjects who received at least 1 dose of study medication.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03523091: OnabotulinumtoxinA Bladder Injection Study
Official title: Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
Sponsor: William Beaumont Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-08
Primary completion date: 2020-09-01
Completion date: 2020-09-01
Baseline population: Of the initial 6 subjects consented, 1 subject was randomized to the 3 injection site arm and 5 were randomized to the 10 injection site arm.
Plan to share individual participant data: NO
IPD sharing description: Participant data will not be available
Clinical trial NCT03120130: Study of Amblyomin-X in Advanced Solid Tumor
Official title: Phase I Study (First in Humans) of the Amblyomin-X in the Treatment of Patients With Advanced Solid Tumors Refractory or Without Indication / Access to Standard Treatment
Acronym: Amblyomin-X
Sponsor: União Química Farmacêutica Nacional S/A (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Delay in the R \& D stage
Enrollment: 24.0 (ESTIMATED)
Number of arms: 6.0
Start date: 2021-02-15
Primary completion date: 2021-08-20
Completion date: 2022-05-22
Plan to share individual participant data: NO
Clinical trial NCT04700176: A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma
Official title: A Multi-Center Phase 2 Study of Daratumumab With Pomalidomide and Dexamethasone in Combination With All-Transretinoic Acid in Patients With Multiple Myeloma Previously Exposed to Daratumumab-Based Regimens
Sponsor: Hackensack Meridian Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low Accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-02
Primary completion date: 2023-11-15
Completion date: 2023-11-15
Plan to share individual participant data: NO
Clinical trial NCT04362124: Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.
Official title: Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020
Sponsor: Universidad de Antioquia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was stopped because Principal Investigator did not obtain sponsorship to carry it out
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2021-06-30
Completion date: 2021-11-30
Plan to share individual participant data: NO
Clinical trial NCT04303559: The Hemophilia Inhibitor Prevention Trial
Official title: Multicenter, Randomized Phase III Inhibitor Prevention Trial, Comparing Eloctate vs. Emicizumab to Prevent Inhibitor Formation in Severe Hemophilia A
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-11
Primary completion date: 2022-04-06
Completion date: 2022-06-16
Plan to share individual participant data: YES
IPD sharing description: A biologic specimen and data repository for this trial will be available at the Graduate School of Public Health (GSPH) Data Center repository for investigators who make formal application request and is formally approved by the Coordinating Center (Pitt) and Data Center (GSPH).
IPD time frame: Within one year of trial completion.
IPD access criteria: Access will be determined by Study Team.
Clinical trial NCT02572453: Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL
Official title: Phase 2 Trial of the Heat Shock Protein-90 (Hsp90) Inhibitor AT13387 (Onalespib) in Patients With Relapsed/Refractory ALK+ ALCL, Mantle Cell Lymphoma, and BCL6+ DLBCL
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Drug supply issues
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-04
Primary completion date: 2021-03-18
Completion date: 2021-03-18
Clinical trial NCT05027867: KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Official title: An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Sponsor: Kartos Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-06
Primary completion date: 2022-08-26
Completion date: 2022-08-26
Clinical trial NCT03845322: Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence
Official title: Clinical Action of Curcumin/Turmeric in Chronic Subdural Hematoma Recurrence
Acronym: CACTIS
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: 12 Screen failures and Changes in PI and loss of residency program.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-18
Primary completion date: 2020-02-26
Completion date: 2020-02-26
Plan to share individual participant data: NO
Clinical trial NCT03558516: Magnesium and Intraoperative Blood Loss in Meningioma Surgery
Official title: The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
Sponsor: Mahidol University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-01
Primary completion date: 2020-02-03
Completion date: 2020-02-18
Plan to share individual participant data: NO
Clinical trial NCT03670953: A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
Official title: A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations
Sponsor: Impax Laboratories, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 630.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-11-06
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Baseline population: The Safety Analysis Set included all participants who were treated with any study drug.
Plan to share individual participant data: NO
Clinical trial NCT03933449: Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
Official title: A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-29
Primary completion date: 2019-02-13
Completion date: 2022-03-14
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05366855: Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
Official title: A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Acronym: GEMINI-2
Sponsor: AnaptysBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest patient having been treated through 92 weeks
Enrollment: 42.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-21
Primary completion date: 2024-02-08
Completion date: 2024-07-17
Plan to share individual participant data: NO
Clinical trial NCT03964207: A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Open-label, Two-way Crossover Study to Compare Patient Acceptability/Preference of Tiotropium Respimat® With Tiotropium Handihaler® in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-25
Primary completion date: 2021-10-19
Completion date: 2021-11-16
Baseline population: Treated set (TS) is defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03176771: Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Fixed-Dose Study to Evaluate the Efficacy and Safety of MT-5199 for the Treatment in Patients With Tardive Dyskinesia (J-KINECT)
Sponsor: Mitsubishi Tanabe Pharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-06-21
Primary completion date: 2020-09-29
Completion date: 2020-09-29
Baseline population: Safety analysis set