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ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Chimerix
H3 K27M
Glioma
This is a randomized, double-blind, placebo-controlled, parallel-group, international,
Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess
whether treatment with ONC201 following frontline radiotherapy will extend overall
survival and progression-free survival in... expand
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Type: Interventional Start Date: Jan 2023 |
A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute...
Biogen
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab)
compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus
Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)]
and the Cutaneous Lupus Erythematosus... expand
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B]. Type: Interventional Start Date: Sep 2022 |
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
Pfizer
Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, efficacy,
pharmacokinetics and pharmacodynamics of osivelotor. expand
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor. Type: Interventional Start Date: Sep 2022 |
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Occlutech International AB
Stroke
Patent Foramen Ovale
The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke,
and device/procedure related Serious... expand
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE). Type: Interventional Start Date: Apr 2022 |
Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
University of Colorado, Denver
Turner Syndrome
INSIGHTS is a registry research study that collects key information on medical history
for girls and women with Turner syndrome and the clinical care they receive. This
includes genetic tests, imaging, medications, and more for hundreds of patients seen at a
number of clinics across the US. In addition... expand
INSIGHTS is a registry research study that collects key information on medical history for girls and women with Turner syndrome and the clinical care they receive. This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. In addition to learning a lot about the current state of health for individuals with TS, INSIGHTS serves as an infrastructure to conduct future studies are meaningful to patients and their families. Type: Observational [Patient Registry] Start Date: May 2020 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Jason Sperry
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize... expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
American Thrombosis and Hemostasis Network
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with
Hemophilia A or B with inhibitors12 years of age and older, who are either on long term
prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding
event (BE), or who are not on prophylactic... expand
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE. Type: Interventional Start Date: Jun 2021 |
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Forma Therapeutics, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of
etavopivat and test how well etavopivat works compared to placebo to improve the amount
of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when
the blood vessels become blocked and... expand
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain). Type: Interventional Start Date: Mar 2021 |
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess...
AbbVie
Endometriosis
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of
childbearing age. Endometriosis affects daily activities, social relationships, sexuality
and sexual activity, and mental health. This study will evaluate how well elagolix in
combination with combined oral contraceptives... expand
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Aug 2020 |
MitraClip REPAIR MR Study
Abbott Medical Devices
Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical
outcome of MitraClip™ device versus surgical repair in patients with severe primary MR
who are at moderate surgical risk and whose mitral valve has been determined to be
suitable for correction by MV repair surgery... expand
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Type: Interventional Start Date: Jul 2020 |
Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents...
The University of Texas Health Science Center, Houston
Child Obesity
Cardiometabolic Health
The purpose of this study is to examine the effects of the (Brighter Bites (BB)
intervention compared to a wait-list control group 9 months after the intervention on
changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary
outcomes (household food security status, parent... expand
The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes. Type: Interventional Start Date: Aug 2024 |
A Study of Auxora in Patients with AKI and Injurious Lung "Crosstalk"
CalciMedica, Inc.
Acute Kidney Injury
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic
respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be
randomly assigned to either Auxora or matching placebo. Study drug infusions will occur
every 24 hours for five consecutive days... expand
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. Type: Interventional Start Date: Jul 2024 |
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women With Substance Use Disorders
The University of Texas Health Science Center, Houston
Substance Use
The goal of this clinical trial is to test an addiction-clinic based behavioral
intervention for increasing PrEP uptake and adherence among women who engage in high-risk
sexual behaviors and problematic substance use. The main question it aims to answer is:
• If the integrated intervention increase... expand
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: • If the integrated intervention increase PrEP uptake and adherence compared to standard treatment Participants will - receive provision of PrEP information through 4 counseling sessions - prevention navigation - receive nurse practitioner prescribed PrEP in an addiction treatment setting Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence Type: Interventional Start Date: Jun 2022 |
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects with Relapsing-Remitting Multiple Sclerosis
Contineum Therapeutics
Relapsing Remitting Multiple Sclerosis
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with
relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate
cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total
duration of approximately 30 weeks. expand
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks. Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Emalex Biosciences Inc.
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability
of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12
years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age)
with Tourette's Syndrome (TS). expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
The PROTEMBO Trial
Protembis GmbH
Severe Aortic Valve Stenosis
The goal of this prospective, multi-center, randomized, controlled study is to compare
the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid
control (no embolic protection device ('No Device') and the Sentinel device) in subjects
with severe symptomatic native aortic... expand
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure. Type: Interventional Start Date: Mar 2024 |
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Stryker Trauma and Extremities
Rotator Cuff Tears
Rheumatoid Arthritis Shoulder
Osteoarthritis Shoulder
Avascular Necrosis of the Head of Humerus
Fracture, Humeral
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to
collect safety and performance data on the commercially available Shoulder iD™ Primary
Reversed Glenoid device. The study will learn about standard device use in adult patients
who have a functional deltoid muscle... expand
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: - What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and - What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes. Type: Observational Start Date: Oct 2023 |
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease...
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Celiac Disease
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic
(PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD). expand
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD). Type: Interventional Start Date: Nov 2022 |
Study of Inupadenant (EOS100850) with Chemotherapy As Second Line Treatment for Nonsquamous Non-small...
iTeos Therapeutics
Metastatic NSCLC - Non-Small Cell Lung Cancer
Locally Advanced NSCLC - Non-Small Cell Lung Cancer
The study will first determine the optimal dose of inupadenant to be given in combination
with carboplatin and pemetrexed to patients that progressed after receiving first line
anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The
efficacy and safety of the combination... expand
The study will first determine the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving first line anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The efficacy and safety of the combination is then compared to standard of care carboplatin and pemetrexed in the same populations. Type: Interventional Start Date: Aug 2022 |
Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment...
AbbVie
Migraine
Migraine is a common neurological disorder typically characterized by attacks of
throbbing, moderate to severe headache, often associated with nausea, vomiting, and
sensitivity to light and sound. Migraine is extremely common and disabling in children.
The purpose of this study is to evaluate how... expand
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jan 2022 |
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Neovasc Inc.
Refractory Angina
To demonstrate the safety and effectiveness of the Reducer system for treatment of
patients with refractory angina pectoris treated with maximally tolerated
guideline-directed medical therapy who demonstrate objective evidence of reversible
myocardial ischemia in the distribution of the left coronary... expand
To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm will further assess the safety and effectiveness of the Neovasc Reducer System in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects with reversible myocardial ischemia without documented obstructive coronary disease and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation. Type: Interventional Start Date: Jan 2022 |
A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)
ModernaTX, Inc.
Glycogen Storage Disease
The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via
intravenous (IV) administration in adult and pediatric participants with GSD1a. expand
The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a. Type: Interventional Start Date: Jun 2022 |
CHIlled Platelet Study "CHIPS"
Philip Spinella
Acute Blood Loss
A phase 3 randomized partial blind storage duration ranging study in patients undergoing
complex cardiac surgery that will compare the transfusion of cold stored platelets to
standard room temperature stored platelets. The primary objective is to establish that
cold stored platelets have a non-inferiority... expand
A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets. Type: Interventional Start Date: Oct 2021 |
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Eisai Inc.
Epilepsies, Myoclonic
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy
compared to placebo on percent change in frequency of convulsive seizures per 28 days in
participants with Dravet syndrome. expand
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome. Type: Interventional Start Date: Sep 2020 |
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
The University of Texas Health Science Center, Houston
Spinal Cord Injuries
The purpose of this study is to determine if electric stimulation to the leg, called
transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute
spinal cord injury. expand
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury. Type: Interventional Start Date: Jun 2020 |
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