Search Clinical Trials
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Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of refractory focal epilepsy. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: May 2024 |
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Boehringer Ingelheim
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse
cutaneous systemic sclerosis. People with another subtype called limited cutaneous
systemic sclerosis can also participate if they are... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
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 |
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 |
Evaluate the Neurological Effects of EryDex on Subjects With A-T
Quince Therapeutics S.p.A.
Ataxia Telangiectasia
This is an international, multi-center, randomized, prospective, double-blind,
placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone
sodium phosphate [DSP] in autologous erythrocytes), administered by intravenous (IV)
infusion once every 28 days, on neurological... expand
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate [DSP] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangectasia (A-T). Type: Interventional Start Date: Jun 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 Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to...
Merck Sharp & Dohme LLC
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in
participants with moderately to severely active ulcerative colitis. Study 1's primary
hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the
proportion of participants achieving clinical... expand
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 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 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
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 |
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 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 |
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 |
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 |
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 |
Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine...
David Ilan Sandberg
Recurrent Ependymoma
Recurrent Medulloblastoma
CNS Malignancies
The goal of this clinical trial is to assess the safety, toxicity, and antitumor activity
of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma
and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies.
Additionally, the study will... expand
The goal of this clinical trial is to assess the safety, toxicity, and antitumor activity of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies. Additionally, the study will explore immunologic responses to nivolumab. The hypothesis is that local administration of nivolumab, an immune checkpoint inhibitor, is safe and will lead to even more robust treatment responses when administered following 5-azacytidine in patients with recurrent ependymoma or methotrexate in patients with medulloblastoma or other CNS tumors. Type: Interventional Start Date: Jul 2024 |
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
The University of Texas Health Science Center, Houston
Stimulant Use Disorder
The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep,
stress, and drug craving during early abstinence from stimulants and to determine the
effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30)
residential program length of stay (LOS)... expand
The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate. Type: Interventional Start Date: Jul 2024 |
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe...
Nektar Therapeutics
Moderate to Severe Atopic Dermatitis
This is an interventional, randomized, parallel group, treatment, Phase IIb, double
blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2
(rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening... expand
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period. Type: Interventional Start Date: Oct 2023 |
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