chufangao/CTO huggingface dataset:
Clinical trial NCT03915067: BOTOX® for the Treatment of Platysma Prominence
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 171.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-23
Primary completion date: 2020-04-16
Completion date: 2020-04-16
Baseline population: mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol.
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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT04287348: Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept
Official title: Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept
Acronym: ROBIN
Sponsor: Vista Klinik (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: due to safety letter beovu from Novartis
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-20
Primary completion date: 2021-11-22
Completion date: 2021-11-22
Plan to share individual participant data: NO
Clinical trial NCT04243278: Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC)
Official title: Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC)
Acronym: PAPVASC
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Poor Recruitment Rates
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-14
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04061330: Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Official title: Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was terminated prior to enrollment due to lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03704077: An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Official title: A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Replaced it with another clinical trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-10-31
Primary completion date: 2022-02-27
Completion date: 2024-09-30
Plan to share individual participant data: YES
IPD sharing description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Clinical trial NCT03108690: Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
Official title: Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
Sponsor: Hvidovre University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Logistics
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-01
Primary completion date: 2023-03-09
Completion date: 2023-03-09
Clinical trial NCT03137199: Allogeneic Human Cells (hMSC) Via Intravenous Delivery in Patients With Mild Asthma
Official title: A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Mild Asthma
Acronym: ASTEC
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: First cohort completed. Per sponsor decision.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-22
Primary completion date: 2020-03-03
Completion date: 2020-04-29
Plan to share individual participant data: NO
Clinical trial NCT03656380: Mepo for Eosinophilic Esophagitis (EoE) Study
Official title: A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-20
Primary completion date: 2022-06-06
Completion date: 2022-12-09
Plan to share individual participant data: NO
Clinical trial NCT02814019: A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids
Official title: A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids
Acronym: SIDEROS
Sponsor: Santhera Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Interim analysis concluded to futility
Enrollment: 255.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-30
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT03894813: Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Sponsor: Peking University Shenzhen Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-26
Primary completion date: 2020-12-30
Completion date: 2020-12-30
Plan to share individual participant data: NO
Clinical trial NCT04603027: A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
Sponsor: Evelo Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 249.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-21
Primary completion date: 2021-07-02
Completion date: 2021-12-06
Plan to share individual participant data: NO
Clinical trial NCT02873351: A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
Official title: Pilot Study of L-DOPA Safety and Tolerability in Patients With AMD, and Proof of Concept That L-DOPA Improves Surrogate Biomarkers in Patients With Moderate to Advanced AMD
Sponsor: Snyder, Robert W., M.D., Ph.D., P.C. (INDIV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Decided to do studies in patients with AMD
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04459338: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Official title: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-04
Primary completion date: 2022-06-14
Completion date: 2022-06-14
Baseline population: Subjects without diabetes to enable evaluation of insulin secretory capacity
Plan to share individual participant data: NO
Clinical trial NCT04287179: SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Official title: Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs
Acronym: SUSTAIN SWITCH
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-09
Primary completion date: 2020-11-16
Completion date: 2021-01-25
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
Clinical trial NCT04229901: Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
Official title: Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF
Acronym: DHELIVER
Sponsor: Cellaion SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 133.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-21
Primary completion date: 2024-05-10
Completion date: 2024-05-10
Plan to share individual participant data: NO
Clinical trial NCT03122106: Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen DNA Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-05
Primary completion date: 2021-09-03
Completion date: 2022-08-13
Plan to share individual participant data: NO
Clinical trial NCT02065557: Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 101.0 (ACTUAL)
Number of arms: 6.0
Start date: 2014-10-13
Primary completion date: 2020-02-07
Completion date: 2020-02-07
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 NCT01532089: Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Official title: A Randomized Phase II Trial of Erlotinib Alone or in Combination With Bevacizumab in Patients With Non-Small Cell Lung Cancer and Activating Epidermal Growth Factor Receptor Mutations
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-03-16
Primary completion date: 2018-02-13
Completion date: 2020-08-18
Clinical trial NCT03006679: A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
Official title: A Phase IIIb, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia in Hospitalized Adults (TANGO III)
Acronym: TANGOIII
Sponsor: Melinta Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-31
Primary completion date: 2020-06-30
Completion date: 2020-12-31
Clinical trial NCT04666298: Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Official title: A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Acronym: ORION-15
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 312.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-01-29
Primary completion date: 2022-04-18
Completion date: 2022-10-19
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 NCT02204462: FBnTP Imaging of Breast Cancer
Official title: FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lock of funding
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-03-12
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Plan to share individual participant data: YES
IPD sharing description: via manuscripts publication
Clinical trial NCT05417113: Erector Spinae Block for Spine Surgery
Official title: Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment difficulty
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-31
Primary completion date: 2024-02-27
Completion date: 2024-02-27
Limitations and caveats: Very limited enrollment due to volume of relevant surgeries and patient eligibility. Opioid consumption confounded by nonuniform usage of PCAs post-operatively.
Plan to share individual participant data: NO
IPD sharing description: IRB approval was not obtained to share IPD.
Clinical trial NCT03104413: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 618.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-12-18
Primary completion date: 2020-11-30
Completion date: 2021-05-19
Baseline population: The safety population (SA) 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 NCT02256280: A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
Official title: Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
Acronym: DATA
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low recruiting rate due to not activation of some collaborator centers
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Clinical trial NCT03158285: A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 741.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-07-12
Primary completion date: 2019-02-25
Completion date: 2020-11-10
Clinical trial NCT04373252: FMT as a Treatment for Severe Motility Disorder
Official title: Fecal Microbiota Transplant as a Treatment for Severe Motility Disorder
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Source of FMT preps is no longer able to provide us with necessary preps.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-31
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Plan to share individual participant data: NO
Clinical trial NCT04296838: Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF
Official title: Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
Sponsor: Peking Union Medical College Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-12
Primary completion date: 2020-04-12
Completion date: 2022-02-12
Clinical trial NCT04341870: Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO
Official title: Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial
Acronym: CORIMUNO-VIRO
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: DSMB recommendation (futility)
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-11
Primary completion date: 2020-05-08
Completion date: 2020-08-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04195373: A Safety Study of TMV-018 in Patients With Tumors of the Gastrointestinal Tract
Official title: A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract
Sponsor: Themis Bioscience GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study not started, no subjects recruited.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-11-23
Primary completion date: 2020-11-23
Completion date: 2020-11-23
Plan to share individual participant data: NO
Clinical trial NCT04314713: A Study to Evaluate the Intramuscular Administration of Scopolamine
Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluated The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection
Sponsor: Battelle Memorial Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: DSMB decision due to adverse events
Enrollment: 32.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-06-02
Primary completion date: 2021-04-06
Completion date: 2021-05-06
Plan to share individual participant data: UNDECIDED