Search Clinical Trials
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Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program
Ultragenyx Pharmaceutical Inc
Glycogen Storage Disease Type Ia
The main objective of this observational study is to evaluate the long-term safety and
effectiveness of DTX401 for at least 10 years after DTX401 administration. expand
The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration. Type: Observational Start Date: Nov 2024 |
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Non1
Incyte Corporation
NonSegmental Vitiligo
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream
in pediatric participants with nonsegmental vitiligo. expand
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo. Type: Interventional Start Date: Jan 2025 |
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pe1
AbbVie
Episodic Migraine
A migraine is a moderate to severe headache on one side of the head. A migraine attack is
a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light
and sound, or other symptoms. A number of treatments are available for adults with
migraine but there are limited approve1 expand
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Type: Interventional Start Date: May 2023 |
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediat1
Denali Therapeutics Inc.
Mucopolysaccharidosis II
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active
(standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa
(DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement
therapy (ERT) for mucopolysaccharidosis type II (M1 expand
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria. Type: Interventional Start Date: Jul 2022 |
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P21
The University of Texas Health Science Center, Houston
Acute Kidney Injury
The central hypothesis of this research study is that perioperative administration of the
proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney
injury (AKI) following cardiac surgery by activation molecular pathways for kidney
protection. The investigators propose a1 expand
The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce the incidence of AKI, some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 3 days perioperatively. Our study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine. Type: Interventional Start Date: Jan 2025 |
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque P1
Alumis Inc
Plaque Psoriasis
The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe
plaque psoriasis. The main questions it aims to answer are:
- Does ESK-001 reduce the severity of people's psoriasis?
- How safe is ESK-001 in people with moderate to severe plaque psoriasis?
The study1 expand
The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: - Does ESK-001 reduce the severity of people's psoriasis? - How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: - take drug every day for 24 weeks. - visit the clinic for checkups and tests. - fill out questionnaires about their psoriasis, itch severity, and change in quality of life. - be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. - provide blood and urine samples. Type: Interventional Start Date: Jul 2024 |
INDV-6001 Multiple-Dose Pharmacokinetic Study
Indivior Inc.
Moderate to Severe Opioid Use Disorder
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants
with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental
Disorders, 5th edition (DSM-5).
The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of1 expand
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment. Type: Interventional Start Date: Sep 2024 |
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestatio1
Ohio State University
Gestational Diabetes Mellitus
Pregnancy, High Risk
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness
pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up
through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized
to oral metformin versus injectable in1 expand
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum. Type: Interventional Start Date: Aug 2024 |
StrokeNet Thrombectomy Endovascular Platform
Medical University of South Carolina
Ischemic Stroke
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the
care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel
occlusions (MVO). expand
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). Type: Interventional Start Date: Jan 2025 |
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disor1
The University of Texas Health Science Center, Houston
Cocaine Use Disorder
The purpose of this study is to assess effects of intermittent theta burst stimulation
(iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex
(dmPFC) compared to sham on electrophysiological indices of reward sensitivity and
motivated attention in adults with cocain1 expand
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder. Type: Interventional Start Date: Nov 2024 |
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Hope Biosciences
Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the
potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences
adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional
outcomes, and neuroinflammation after traumati1 expand
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury. Type: Interventional Start Date: Apr 2024 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolesc1
Amgen
Atopic Dermatitis
The primary objective of this study is to describe the long-term safety and tolerability
of rocatinlimab in participants with moderate-to-severe AD. expand
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD. Type: Interventional Start Date: May 2023 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage1
NRG Oncology
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph
node dissection in reducing the risk of swelling in the legs (lymphedema) in patients
undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection
removes lymph nodes around the ute1 expand
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs. Type: Interventional Start Date: Dec 2022 |
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of1
Genelux Corporation
Platinum-resistant Ovarian Cancer
Platinum-refractory Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
High-grade Serous Ovarian Cancer
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the
safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab
compared to the Active Comparator Arm with Physician's Choice of chemotherapy and
bevacizumab in women diagnosed with pla1 expand
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population. Type: Interventional Start Date: Aug 2022 |
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
DiaMedica Therapeutics Inc
Acute Stroke
Ischemic Stroke
Stroke
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase
alfa) in treating participants with moderate stroke severity, who present within 24 hours
of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This
study focuses on participants with limi1 expand
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites. Type: Interventional Start Date: Nov 2021 |
AlloSure Lung Assessment and Metagenomics Outcomes Study
CareDx
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
ALAMO is a prospective, multi-center, perspective, registry of patients receiving
LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung
(dd-cfDNA) to detect a spectrum of rejec1 expand
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic). Type: Observational [Patient Registry] Start Date: Oct 2021 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Ri1
NRG Oncology
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salp1 expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in C1
Epizyme, Inc.
Relapsed/Refractory Follicular Lymphoma
Follicular Lymphoma
Refractory Follicular Lymphoma
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the
disease has come back after a period of improvement after that follows a treatment
regimen and 'refractory' when treatment no l1 expand
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. Type: Interventional Start Date: Jun 2020 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 251 expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitat1 expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Se1
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande1
The University of Texas Health Science Center, Houston
Stroke
The purpose of this study is to investigate the feasibility of a mobile
telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke
survivors with community health worker (CHW) at-home support and to estimate the
functional health, mental health (depression), and careg1 expand
The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities. Type: Interventional Start Date: Mar 2025 |
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Takeda
Plaque Psoriasis
The main aim of this study is to check the side effects of TAK-279 and how well it is
tolerated in participants with moderate-to-severe plaque psoriasis.
All participants will be assigned to study treatments of TAK-279 and will be treated with
TAK-279 if the participants meet the study rules.
Par1 expand
The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times. Type: Interventional Start Date: Sep 2024 |
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