chufangao/CTO huggingface dataset:
Clinical trial NCT03227432: An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Official title: An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn before enrollment due to issues around the FDA hold on PD-1/PD-L1 drugs in combination with IMIDs.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-31
Primary completion date: 2021-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05067972: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors
Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN ADVANCED OR METASTATIC SOLID TUMORS
Acronym: C4431001
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.
Enrollment: 30.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-07
Primary completion date: 2023-10-17
Completion date: 2023-10-17
Plan to share individual participant data: NO
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 NCT03201952: Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans
Official title: Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Difficulty in participant recruitment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-01
Primary completion date: 2020-05-01
Completion date: 2020-05-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03257631: A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors
Official title: A PHASE 2 CLINICAL STUDY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR CHILDREN AND YOUNG ADULTS WITH RECURRENT OR PROGRESSIVE PRIMARY BRAIN TUMORS
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-18
Primary completion date: 2023-09-14
Completion date: 2023-09-14
Baseline population: The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
Clinical trial NCT03945799: A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
Official title: A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.
Sponsor: Zhejiang University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study has gotten preliminary results and stopped advanced.
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-22
Primary completion date: 2022-06-25
Completion date: 2022-06-25
Plan to share individual participant data: YES
Clinical trial NCT02911935: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
Official title: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
Acronym: APW-RSV-II
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Limitations and caveats: 1. Our ultimate goal was to examine an asthma prevention strategy. However, the primary outcome was defined as recurrent wheeze during 2-4 years of follow-up. This was previously done in other studies in this field.~2. The study primary outcome measure was wheeze assessed by the parents, which has a relatively low correlation with wheeze assessed by physicians. However, a systematic bias is unlikely as both groups were evaluated by the same method
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to study documents, including the study protocol with any amendments and blank case report forms.~Upon reasonable request, these data will be provided by Dr. Charles Goss, the study statistician. email: cwgoss@wustl.edu
IPD time frame: A month after publication
IPD access criteria: See above
Clinical trial NCT03282799: Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
Official title: Pharmacokinetic and Pharmacodynamic Evaluation of Etonogestrel Dose Escalation With Efavirenz-based Antiretroviral Therapy in HIV-infected Ugandan
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-19
Primary completion date: 2020-12-22
Completion date: 2022-10-25
Baseline population: All enrolled participants
Plan to share individual participant data: NO
Clinical trial NCT05225558: A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
Official title: A Multicenter, Double-blinded, Randomized, Parallel Design, Phase IIa Clinical Trial to Evaluate the Efficacy, Safety and PK of LCB01-0371 With Vancomycin Versus Vancomycin Monotherapy in Patients With MRSA Bacteremia
Sponsor: LigaChem Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-26
Primary completion date: 2024-02-16
Completion date: 2024-02-16
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First results will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.
IPD time frame: IPD will be provided 1-2 years after and up to 5 years after the publication of the article on the results of the trial.
IPD access criteria: IPD access will be provided for analyses of the related to the aims of research described in the protocol and for individual patient data meta analyses to researches who provide a methodologically sound proposal to lcb_pv@legochembio.com
Clinical trial NCT04155008: Nutrition and Pharmacological Algorithm for Oncology Patients Study
Official title: Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-01
Primary completion date: 2021-04-05
Completion date: 2021-04-05
Baseline population: Only 1 participant was enrolled in this study.
Limitations and caveats: The primary and secondary outcomes were unable to be assessed as only 1 patient (out of a planned 30) was enrolled into the study. No analyses were therefore conducted.
Plan to share individual participant data: NO
Clinical trial NCT04142619: Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)
Official title: Phase I, Open-label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A (Allogenic Engineered T-cells Expressing Anti-CS1 Chimeric Antigen Receptor) Administered in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor: Cellectis S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-21
Primary completion date: 2023-06-18
Completion date: 2023-06-18
Plan to share individual participant data: NO
Clinical trial NCT01961804: PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
Official title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment
Acronym: PREVACT
Sponsor: University Hospital, Angers (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Enrollment: 202.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-31
Primary completion date: 2020-02-28
Completion date: 2020-09-03
Clinical trial NCT04398199: Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
Official title: A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accruals
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-16
Primary completion date: 2020-11-20
Completion date: 2020-11-20
Limitations and caveats: One patient was accrued to this trial. He was assigned to the intervention arm. He began on study on 10/16/2020, and began treatment on 10/19/2020. He went off treatment 11/20/2020 due to a fall-he did not return for follow-up after week 3. He expired on 1/8/2021. The study was terminated early due to slow accruals which did not allow enough time for data collection for any outcome measures to properly assess the clinical trial.
Plan to share individual participant data: NO
Clinical trial NCT04944888: GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor in Previously Treated Blood and Solid Tumor
Official title: Phase ⅠStudy of GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor in Treating Patients With Advanced Relapsed or Refractory Hematological Malignancies and Previously Treated Solid Tumors
Sponsor: Chinese PLA General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-01
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: NO
Clinical trial NCT05683860: Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
Official title: A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
Sponsor: Wave Life Sciences Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Despite robust, sustained reductions in poly(GP), no clinical benefit was seen at 24 weeks, and reductions in poly(GP) were not associated with stabilization in functional outcomes. Based on these data, Wave decided to stop development of WVE-004.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-14
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Clinical trial NCT04438850: COVidIVERmectin: Ivermectin for Treatment of Covid-19
Official title: Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the Early Treatment of COVID-19
Acronym: COVER
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Incidence has dramatically dropped and there is lack of eligible patients
Enrollment: 93.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-31
Primary completion date: 2021-06-08
Completion date: 2021-06-08
Plan to share individual participant data: YES
IPD sharing description: The anonymized database will be uploaded into a public repository
IPD time frame: The database will be available upon publication of the results
IPD access criteria: The data will be available in a public repository
Clinical trial NCT03794037: Montelukast for Prevention & Treatment of OHSS
Official title: Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
Sponsor: Benha University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: no fund
Enrollment: 20.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-12-05
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: study protocol, results,statistics
IPD time frame: 6 months
IPD access criteria: drahmedsaad@live.com
Clinical trial NCT02662985: Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
Official title: A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis
Acronym: PDUS
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 166.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-08-22
Primary completion date: 2020-11-10
Completion date: 2020-11-10
Plan to share individual participant data: UNDECIDED
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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 NCT03639766: The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Official title: The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
Sponsor: University of Central Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Time and resource constraints
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Plan to share individual participant data: NO
Clinical trial NCT05127122: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS
Official title: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Acute Respiratory Distress Syndrome: A Phase I/II Clinical Trial
Acronym: EXIT-ARDS
Sponsor: Direct Biologics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Change in development plan
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2024-12-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT04694300: OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
Official title: Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients
Sponsor: Hersh, Elliot V., DMD, MS, PhD (INDIV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-07
Primary completion date: 2022-08-28
Completion date: 2022-08-28
Limitations and caveats: Research study as described in the results manuscript only evaluated 30 subjects but it is the first of it's kind. Our analysis was not powered to comprehensively evaluate the clinical and demographic factors that influence the local and systemic inflammatory response to implant placement surgery or drug response. In addition, we excluded smokers and patients with diabetes, autoimmune diseases, or other comorbidities that might influence the inflammatory response to implant placement surgery.
Plan to share individual participant data: NO
IPD sharing description: IPD will not be shared. This is a pilot, exploratory study.
Clinical trial NCT05366439: Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model
Sponsor: Atea Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision to deprioritize the dengue program
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-22
Primary completion date: 2023-03-16
Completion date: 2023-03-16
Clinical trial NCT05294328: Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Official title: A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Sponsor: LENZ Therapeutics, Inc (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-05-05
Primary completion date: 2022-08-22
Completion date: 2022-09-10
Plan to share individual participant data: NO
Clinical trial NCT04314843: Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
Official title: A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)
Acronym: ZUMA-19
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Development program terminated and the decision was not due to any safety concerns.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-26
Primary completion date: 2021-03-16
Completion date: 2022-07-27
Baseline population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel and/or any dose of lenzilumab.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT04012099: the Hypertrophic Scar Prevention of BMT101.
Official title: An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar
Sponsor: Hugel (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Internal reasons
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-21
Primary completion date: 2023-05-10
Completion date: 2023-05-10
Plan to share individual participant data: NO
Clinical trial NCT04332991: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Official title: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Acronym: ORCHID
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 479.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-02
Primary completion date: 2020-06-19
Completion date: 2020-07-23
Clinical trial NCT03478865: Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
Official title: An Investigation of Vitamin A Palmitate Supplementation in Patients With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-20
Primary completion date: 2023-06-16
Completion date: 2023-06-16
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05222178: Safety and Efficacy of HMI-103 in Participants With Classical PKU Due to PAH Deficiency
Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of HMI-103 Administered Intravenously in Adult Participants With Classical PKU Due to PAH Deficiency
Sponsor: Homology Medicines, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Homology Medicines Inc. has discontinued the development of this program.
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-06-03
Primary completion date: 2023-09-14
Completion date: 2023-09-14
Clinical trial NCT04271475: A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Official title: A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Acronym: MACiTEPH
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Sponsor decided to stop the study for futility based on a recommendation by the IDMC following a pre-planned interim analysis
Enrollment: 127.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-07
Primary completion date: 2023-12-21
Completion date: 2023-12-21
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 NCT01838174: A Trial of Neuroprotection With ACTH in Acute Optic Neuritis
Official title: A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis
Acronym: ACTHAR
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor requested
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-31
Primary completion date: 2022-01-13
Completion date: 2022-01-13
Plan to share individual participant data: NO