chufangao/CTO huggingface dataset:
Clinical trial NCT03403725: MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
Official title: Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma
Acronym: CD205SHUTTLE
Sponsor: Menarini Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-28
Primary completion date: 2019-10-22
Completion date: 2020-01-08
Clinical trial NCT04602065: Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial
Official title: Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-24
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Clinical trial NCT04862143: Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
Official title: Open-label, Multicenter, Pilot-trial Evaluating the Safety and Utility of a Hybrid Decentralized Clinical Trial (DCT) Approach Using a TELEmedicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
Acronym: TELEPIK
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study early terminated due to low enrollment compared to the anticipated figures
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-08
Primary completion date: 2022-09-19
Completion date: 2022-09-19
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT03829696: Advance Provision of Medication Abortion
Official title: Alternative Provision of Medication Abortion Via Advance Provision
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The study is not proceeding at this time.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
Clinical trial NCT03771105: The Impact of Phosphate Metabolism on Healthy Aging
Official title: The Impact of Phosphate Metabolism on Healthy Aging
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: SUSPENDED 
Why stopped: lack of funding
Enrollment: 30.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2019-01-01
Primary completion date: 2024-08-31
Completion date: 2024-08-31
Clinical trial NCT03695172: Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Official title: Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Decline of eligible participants
Enrollment: 12.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-12
Primary completion date: 2021-03-18
Completion date: 2021-03-20
Plan to share individual participant data: NO
Clinical trial NCT04300140: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Official title: A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Sponsor: Aravive, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to business reasons
Enrollment: 72.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-02-26
Primary completion date: 2023-08-14
Completion date: 2023-08-14
Plan to share individual participant data: NO
Clinical trial NCT03291353: Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia
Official title: Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: This study has closed due to slow accrual.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-17
Primary completion date: 2019-08-19
Completion date: 2022-08-19
Clinical trial NCT04168190: A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)
Official title: A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 600.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-12-06
Primary completion date: 2021-07-12
Completion date: 2021-07-12
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02576574: Avelumab in First-line NSCLC (JAVELIN Lung 100)
Official title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1214.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-10-29
Primary completion date: 2021-12-06
Completion date: 2024-01-29
Clinical trial NCT02976766: Gypenosides Treatment for Optic Neuritis
Official title: Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial
Sponsor: First Affiliated Hospital of Guangxi Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrolment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-04
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT04475601: Enzalutamide Treatment in COVID-19
Official title: A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
Acronym: COVIDENZA
Sponsor: Region Västerbotten (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: By sponsor, based on DSMB recommendations
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-15
Primary completion date: 2021-03-24
Completion date: 2021-05-29
Plan to share individual participant data: UNDECIDED
IPD sharing description: The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
Clinical trial NCT03057951: EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Official title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 5988.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-02
Primary completion date: 2021-04-26
Completion date: 2021-04-26
Baseline population: Randomised Set (RS), including all randomised patients.
Clinical trial NCT03567694: Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers
Official title: Randomized Double-Blind Placebo-controlled Ascending Dose FIH Study to Evaluate Single and Multiple Doses of HA115 in Healthy Volunteers and to Investigate Food Effect on Pharmacokinetics After Single Oral Doses of HA115
Sponsor: Conjupro Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2022-10-10
Completion date: 2022-10-12
Plan to share individual participant data: NO
Clinical trial NCT04991753: A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-14
Primary completion date: 2022-08-10
Completion date: 2022-08-10
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 NCT05332678: SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease
Official title: An Open-Label, Proof-of-Concept Study to Evaluate the Safety and Treatment Effects of SLS-005 (Trehalose Injection, 90.5 mg/mL for Intravenous Infusion) in Participants With Alzheimer's Disease (AD)
Acronym: [STRIVE-AD]
Sponsor: Seelos Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-03
Primary completion date: 2023-04-10
Completion date: 2023-04-10
Plan to share individual participant data: NO
Clinical trial NCT01639001: A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
Official title: PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 207.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-09-29
Primary completion date: 2015-06-30
Completion date: 2020-01-08
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03123861: Gabapentin for Postop Pain After SSLF
Official title: Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-01
Primary completion date: 2020-07-25
Completion date: 2020-07-25
Plan to share individual participant data: NO
Clinical trial NCT04580121: A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.
Official title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 59.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-11-04
Primary completion date: 2023-08-09
Completion date: 2023-08-09
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT03582280: The Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare in Late-stage Solid Cancer Subjects
Official title: Study to Improve the Function and Welfare of Late-stage Solid Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation
Acronym: ONCO-004-1
Sponsor: Amorphical Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-18
Primary completion date: 2022-06-30
Completion date: 2022-10-31
Clinical trial NCT04614246: Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb
Official title: A Randomized, Double-blind, Open for Active Comparator, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Three Different Doses of P2X3 Antagonist (BAY1817080) Versus Placebo and Elagolix 150 mg in Women With Symptomatic Endometriosis
Acronym: SCHUMANN
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated by Sponsor
Enrollment: 215.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-01-29
Primary completion date: 2022-01-17
Completion date: 2022-05-03
Baseline population: Full analysis set (FAS) includes all 215 participants who were randomized to 5 treatment arms.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Clinical trial NCT04256655: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients
Official title: A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 After Multiple Ascending Oral Dose Administration to Patients With Phenylketonuria (PKU).
Sponsor: Société des Produits Nestlé (SPN) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: study product composition to move from liquid to solid
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-01
Primary completion date: 2021-12-30
Completion date: 2021-12-30
Clinical trial NCT04001101: Anti-PD-1 +/- RT for MSI-H Solid Tumors
Official title: A Randomized Phase II Study of Anti-PD-1 and Limited Metastatic Site Radiation Therapy Versus Anti-PD-1 Alone for Patients With Microsatellite Instability-high (MSI-H) and Mismatch Repair Deficient (dMMR) Metastatic Solid Tumors
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI has decided to withdraw the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-10
Primary completion date: 2021-11-17
Completion date: 2021-11-17
Plan to share individual participant data: NO
Clinical trial NCT02304991: FARE Peanut SLIT and Early Tolerance Induction
Official title: Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children
Acronym: FARE/SLIT
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT03050060: Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer
Official title: ImmunoRad: Stratified Phase II Trial of Image Guided Hypofractionated Radiotherapy With Concurrent Nelfinavir and Immunotherapy in Advanced Melanoma, Lung Cancer, and Renal Cell Carcinoma
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-09
Primary completion date: 2018-10-01
Completion date: 2020-07-12
Plan to share individual participant data: NO
Clinical trial NCT04409834: Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial
Official title: A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients
Acronym: COVID-PACT
Sponsor: The TIMI Study Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 390.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-05
Primary completion date: 2022-03-10
Completion date: 2022-03-10
Plan to share individual participant data: NO
Clinical trial NCT05845008: A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Official title: An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The study is no longer required due to change in development program strategy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-01-15
Primary completion date: 2024-07-15
Completion date: 2024-07-26
Plan to share individual participant data: YES
IPD sharing description: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Clinical trial NCT03416244: A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer
Official title: A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer
Acronym: RAMONA
Sponsor: AIO-Studien-gGmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-21
Primary completion date: 2021-11-19
Completion date: 2021-11-19
Plan to share individual participant data: NO
Clinical trial NCT03757351: Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Amyotrophic Lateral Sclerosis
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to change in Sanofi's development strategy for DNL747/SAR443060 - not due to any safety concerns
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-14
Primary completion date: 2020-06-18
Completion date: 2020-06-18
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04016792: Classroom Study of SPN-812 in Children With ADHD
Official title: An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder
Sponsor: Supernus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study stopped before enrollment due to non-safety related corporate decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-31
Primary completion date: 2020-09-30
Completion date: 2020-11-30
Plan to share individual participant data: NO