chufangao/CTO huggingface dataset:
Clinical trial NCT04366739: Repurposing of Chlorpromazine in Covid-19 Treatment
Official title: Repurposing of Chlorpromazine in Covid-19 Treatment
Acronym: reCoVery
Sponsor: Centre Hospitalier St Anne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No favourable opinion obtained from the Ethics Committee
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-29
Primary completion date: 2020-08-30
Completion date: 2020-09-30
Clinical trial NCT04493684: GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
Official title: A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3739937 in Healthy Participants
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 91.0 (ACTUAL)
Number of arms: 15.0
Start date: 2020-07-31
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT03152084: The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
Official title: DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Either Preserved or Impaired Renal Function and Non-Diabetics With Impaired Renal Function
Acronym: DAPASALT
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Poor recruitment.
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-07-12
Primary completion date: 2020-03-20
Completion date: 2020-03-20
Baseline population: Safety Set: All patients who received at least one dose of study drug and had data from at least one post-dose safety assessment available were included in the safety set.
Limitations and caveats: The study was prematurely closed due to unsatisfactory recruitment rate. Of 5 patients enrolled in the Group 1, none were enrolled into the Run-in set due to failure to meet inclusion/exclusion criteria, screen failure, withdrawal or other reason and hence it was decided that no more Group 1 patients would be enrolled in the study. In Group 2 and 3, 17 and 7 patients received the investigational product and completed the study, respectively.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT05061693: A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 146.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-04
Primary completion date: 2023-08-11
Completion date: 2024-02-28
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT03674320: Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
Official title: Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
Sponsor: The University of Texas Medical Branch, Galveston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: No Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2024-08-01
Completion date: 2024-12-01
Plan to share individual participant data: NO
Clinical trial NCT02363374: Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer
Official title: Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer: A Randomized Phase II Trial of the German Rectal Cancer Study Group
Acronym: CAOAROAIO-12
Sponsor: Goethe University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 311.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-03-25
Primary completion date: 2018-09-30
Completion date: 2023-06-16
Clinical trial NCT03861390: Woodsmoke Particulate + Prednisone
Official title: Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke
Acronym: Smokisone
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-22
Primary completion date: 2023-05-12
Completion date: 2023-05-12
Plan to share individual participant data: NO
Clinical trial NCT04054115: Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow
Official title: The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection
Acronym: Alprostadil
Sponsor: The Hospital for Sick Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Covid 19 and difficulty with recruitment
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-23
Primary completion date: 2021-02-24
Completion date: 2022-11-09
Clinical trial NCT01712659: Ruxolitinib for Adult T-Cell Leukemia
Official title: Phase I/II Trial Evaluating the Safety and Efficacy of Ruxolitinib in Subjects With Smoldering and Chronic Adult T-cell Leukemia (ATL)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The adult T-cell leukemia (ATL) research program was terminated after the death of the T-cell malignancy group Lead investigator.
Enrollment: 19.0 (ACTUAL)
Number of arms: 3.0
Start date: 2012-10-26
Primary completion date: 2021-11-12
Completion date: 2022-01-18
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.
IPD time frame: Clinical data available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT03546400: Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
Official title: A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The study was cancelled prior to the enrollment of any participants.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-25
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Clinical trial NCT04862650: Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Enrollment goal met
Enrollment: 42.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2021-11-30
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT04048876: Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 56.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-14
Primary completion date: 2021-09-28
Completion date: 2021-09-28
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT03006926: A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
Official title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-13
Primary completion date: 2019-10-31
Completion date: 2022-11-22
Baseline population: The efficacy analysis set included all participants who had received at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT04381325: A Study of MSB0254 Injection in Advanced Solid Tumors
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability and Pharmacokinetics of MSB0254 Injection in Patients With Advanced Solid Tumors
Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-01
Primary completion date: 2022-06-08
Completion date: 2022-06-08
Plan to share individual participant data: NO
Clinical trial NCT03657420: Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Official title: A Phase Ib Investigation of the Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding withdrawn by sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-30
Primary completion date: 2021-09-30
Completion date: 2024-09-30
Plan to share individual participant data: NO
Clinical trial NCT04476251: E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer
Official title: A Pilot Study of E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Multiple logistical challenges
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-14
Primary completion date: 2021-09-15
Completion date: 2021-09-15
Plan to share individual participant data: NO
Clinical trial NCT04305327: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
Official title: A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis
Acronym: EMBRACE 1
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Early terminated due to difficulty recruiting participants
Enrollment: 12.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-12-07
Primary completion date: 2023-05-05
Completion date: 2023-05-05
Baseline population: Due to low enrollment, baseline data are not reported to protect participant confidentiality.
Plan to share individual participant data: YES
IPD access criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT03847272: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)
Official title: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)
Acronym: USTEKINISU
Sponsor: Centre Hospitalier Universitaire Dijon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The long inclusion period meant that the question could not be answered within an appropriate timeframe.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-01
Primary completion date: 2023-10-25
Completion date: 2023-10-25
Clinical trial NCT04560166: Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
Official title: Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor in Combination With Irinotecan and Temozolomide in Patients With High-Risk Neuroblastoma With Primary Refractory Disease or in First Relapse. An International, Single-Arm, Multicenter Phase 2 Trial.
Sponsor: Y-mAbs Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to business priorities
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-08
Primary completion date: 2022-09-21
Completion date: 2022-09-21
Limitations and caveats: Terminated due to business priorities resulting from slow recruitment.
Clinical trial NCT02691182: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Official title: Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
Sponsor: Supernus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The program was shut down due to a lack of efficacy.
Enrollment: 491.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-30
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Baseline population: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.
Clinical trial NCT00321698: Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
Official title: Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding withdrawal
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2006-04-21
Primary completion date: 2009-10-01
Completion date: 2023-08-18
Limitations and caveats: Patient accrual was not completed due to the sponsor withdrawing funding.
Clinical trial NCT03897946: Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC
Official title: Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 569.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-20
Primary completion date: 2021-02-05
Completion date: 2021-02-05
Plan to share individual participant data: NO
Clinical trial NCT03366103: Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors
Official title: Phase 1/2 Study of Navitoclax Plus Vistusertib in Patients With Relapsed Small Cell Lung Cancer (SCLC) and Other Solid Tumors
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Drug supply issues
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-20
Primary completion date: 2021-07-28
Completion date: 2022-09-21
Limitations and caveats: Only 1 participant was enrolled to Phase 2 before the study was closed to accrual for low accrual.
Clinical trial NCT02395848: Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
Official title: Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient resource to complete the study
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-07-31
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Clinical trial NCT03242772: Impact of Combined Medication and Behavioral Treatment for ASD & ADHD
Official title: Impact of Combined Medication and Behavioral Treatment in Young Children With Comorbid ASD and ADHD
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study stopped recruitment of new participants due to COVID. A substudy was developed with adaptations to the main design.
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-14
Primary completion date: 2020-12-28
Completion date: 2021-04-19
Plan to share individual participant data: YES
IPD sharing description: Through NDAR, core assessment and diagnostic data that is de-identified, including measures such as ADOS and Vineland.
IPD time frame: 1 year after publication of the results for each of the specific aims or 3 years after the statistical analyses are completed
IPD access criteria: determined by committee of researchers/administrator at NDAR
Clinical trial NCT05270265: Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine
Official title: A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-02-09
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Clinical trial NCT05405439: To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer
Official title: Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor voluntarily terminated the study
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-25
Primary completion date: 2023-07-19
Completion date: 2023-07-19
Clinical trial NCT04988867: An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Official title: An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Acronym: DAFFODIL™
Sponsor: ACADIA Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-22
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Baseline population: All patients enrolled and treated
Limitations and caveats: As a result of marketing approval of trofinetide on 10 March 2023, the study was terminated by the Sponsor with the intent of switching patients to commercially available product. The study was terminated on 31 May 2023.
Plan to share individual participant data: NO