chufangao/CTO huggingface dataset:
Clinical trial NCT02394795: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
Official title: A Phase III, Randomized, Controlled Study of mFOLFOX6 + Bevacizumab Combination Therapy Versus mFOLFOX6 + Panitumumab Combination Therapy in Chemotherapy-naive Patients With KRAS/NRAS Wild-type, Incurable/Unresectable, Advanced/Recurrent Colorectal Cancer
Acronym: PARADIGM
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 823.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-29
Primary completion date: 2022-01-14
Completion date: 2022-01-14
Baseline population: Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation.
Plan to share individual participant data: YES
IPD sharing description: 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.
IPD access criteria: 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.
Clinical trial NCT03720574: Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients
Official title: Efficacy and Safety of Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Adult Obese Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Sponsor: Kanion & Huawe Medicine Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Reassess safety risks and benefits
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-17
Primary completion date: 2020-12-06
Completion date: 2020-12-12
Plan to share individual participant data: NO
Clinical trial NCT04303377: Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
Official title: Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
Acronym: ExOTIC
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The sponsor required early termination of the economic agreement due to a supposed extension of the enrollment period for bureaucracy reasons and for the concomitant Covid -19 Pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-18
Primary completion date: 2020-01-02
Completion date: 2020-07-24
Clinical trial NCT02729805: Intraoperative Ketamine on Chronic Pain After Mastectomy
Official title: Effects of Intraoperative Intravenous Ketamine on Chronic Pain After Mastectomy
Sponsor: The University of Hong Kong (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Not enough patients
Enrollment: 135.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2015-08-18
Primary completion date: 2024-06-30
Completion date: 2024-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03565406: A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
Official title: A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-25
Primary completion date: 2020-01-13
Completion date: 2020-01-13
Clinical trial NCT03864328: A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Official title: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
Acronym: SCENIC
Sponsor: Respivant Sciences Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19 Pandemic
Enrollment: 108.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-29
Primary completion date: 2020-05-29
Completion date: 2020-06-05
Plan to share individual participant data: NO
Clinical trial NCT03920878: Cataract DME - Peri vs. Intraop
Official title: Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study team was unable to secure sufficient funding and administrative support.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
IPD sharing description: No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.
Clinical trial NCT02486406: A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Official title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)
Acronym: ZIRCON
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-10-28
Primary completion date: 2020-11-19
Completion date: 2020-11-19
Baseline population: Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or Part 2
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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT05144347: Study of XL114 in Subjects With Non-Hodgkin's Lymphoma
Official title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL114 Administered in Subjects With Non-Hodgkin's Lymphoma
Sponsor: Exelixis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to Sponsor reasons.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-12
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Clinical trial NCT03512262: Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
Sponsor: Radius Health, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 228.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-03
Primary completion date: 2021-08-17
Completion date: 2021-09-08
Baseline population: ITT Population: All participants randomized into the study.
Clinical trial NCT04539483: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
Official title: A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion
Acronym: MATCH-1
Sponsor: Heidelberg ImmunoTherapeutics GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: stopped for futility in interim analysis
Enrollment: 761.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-08
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT02566993: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
Official title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Acronym: ATLANTIS
Sponsor: PharmaMar (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 613.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-08-30
Primary completion date: 2020-02-24
Completion date: 2020-02-24
Clinical trial NCT05320380: A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat
Official title: A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn per CS0150757
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-08-01
Primary completion date: 2023-09-01
Completion date: 2023-09-01
Clinical trial NCT05106335: A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC
Official title: A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor R \& D Strategy Adjustment
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-06
Primary completion date: 2022-05-11
Completion date: 2022-05-11
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04518137: A Study of Evaluating the Safety and Efficacy of ATG-008 for Advanced Solid Tumors (BUNCH)
Official title: An Open-Label, Single-Arm Basket Study of ATG-008 for the Treatment of Patients With Advanced Solid Tumors Harboring NFE2L2, STK11, RICTOR or Other Specific Genetic Alterations
Sponsor: Antengene Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the low popularity of NGS testing in China and the small number of target subjects, our company decided to adjust the research and development strategy, terminate this study and not apply for new drug registration after careful consideration.
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-09
Primary completion date: 2022-05-30
Completion date: 2022-05-30
Clinical trial NCT05372783: Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
Official title: A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was never launched
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-30
Primary completion date: 2024-06-30
Completion date: 2024-10-31
Clinical trial NCT04154150: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Official title: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-19
Primary completion date: 2022-03-15
Completion date: 2022-03-15
Limitations and caveats: Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.
Plan to share individual participant data: NO
Clinical trial NCT04460729: A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases
Official title: A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, Non Small-Cell Lung Cancer That Has Metastasized to the Brain
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: company decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-11
Primary completion date: 2023-11-17
Completion date: 2023-11-17
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 NCT05053126: Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users
Official title: A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users
Sponsor: Viatris Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-07-27
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Baseline population: The randomized population included all participants who were randomized to a treatment sequence in the Treatment Phase
Plan to share individual participant data: NO
Clinical trial NCT03977974: A Study of LY3526318 in Healthy Participants
Official title: A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: COVID-19 pandemic.
Enrollment: 76.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-21
Primary completion date: 2020-03-05
Completion date: 2020-03-05
Plan to share individual participant data: NO
Clinical trial NCT04476628: Efficacy of Budesonide Via Delayed Release vs Immediate Release
Official title: Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via Delayed Release vs Immediate Release After Administration in the Lying Head Back Position
Sponsor: St. Paul's Hospital, Canada (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Due to COVID-19, we didn't start this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-01
Primary completion date: 2022-01-31
Completion date: 2022-02-28
Plan to share individual participant data: NO
IPD sharing description: We will publish final outcomes as scientific paper.
Clinical trial NCT03950856: Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)
Acronym: PNEU-TRUE
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2340.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-12
Primary completion date: 2020-04-03
Completion date: 2020-04-03
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02790034: Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms
Official title: A Randomised, Double-Blind, Placebo-Controlled 6-month Study to Evaluate the Efficacy, Safety, and Tolerability of Sarizotan in Patients With Rett Syndrome With Respiratory Symptoms
Acronym: STARS
Sponsor: Newron Pharmaceuticals SPA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The study did not demonstrate evidence of efficacy on the primary or secondary efficacy variables
Enrollment: 129.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-10-26
Primary completion date: 2019-08-06
Completion date: 2020-05-04
Limitations and caveats: No efficacy evaluation was performed for the open label extension, as the study was terminated prematurely by the Sponsor based on lack of demonstrated efficacy in the double-blind period.
Clinical trial NCT03410927: A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
Official title: A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities
Sponsor: Taiho Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was stopped due to unacceptable toxicity during the dose-escalation portion (Phase 1) of the study and did not progress to Phase 2
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-06
Primary completion date: 2022-06-09
Completion date: 2022-06-09
Clinical trial NCT01296555: A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
Official title: An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.
Enrollment: 674.0 (ACTUAL)
Number of arms: 6.0
Start date: 2011-03-16
Primary completion date: 2021-06-25
Completion date: 2021-06-25
Baseline population: The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.
Clinical trial NCT03295695: PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Official title: Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: closure of radiolaboratory
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-31
Primary completion date: 2021-12-31
Completion date: 2022-12-31
Clinical trial NCT03347994: Minnelide in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase I Pilot Study of Minnelide, A Novel Heat Shock Protein 70 Inhibitor, in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Discordance in contractual language and terms.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-04-30
Primary completion date: 2021-04-30
Completion date: 2022-04-30
Clinical trial NCT03431974: Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial to Establish the Efficacy and Safety of Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis
Sponsor: Syntrix Biosystems, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2021-01-11
Completion date: 2021-01-11
Plan to share individual participant data: NO
Clinical trial NCT03434028: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Official title: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Acronym: CLOVERS
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1563.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-07
Primary completion date: 2022-05-10
Completion date: 2022-08-24
Limitations and caveats: All cause mortality: To clarify, we did not classify death as anticipated or not anticipated; nor did we collect cause of death for this trial.
Clinical trial NCT01048138: Use of Biperiden for the Prevention of Post-traumatic Epilepsy
Official title: Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
Sponsor: Federal University of São Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-31
Primary completion date: 2022-12-02
Completion date: 2022-12-02