Fiche société
University of South Florida
Traitements, essais et publications liés.
Traitements23programmes
Essais17liés
Publications8liées
SourceDBlocale
Traitements
23| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Levadopa/Carbidopa eyedropsThis study is being conducted at the Morsani College of Medicine to determine whether signals recorded from the eyes and brain can be used as a noninvasive way to monitor dopamine function. Approximately 50 adults (25 with Parkinson's disease and 25 without Parkinson's disease) will participate. Participants will undergo electroretinography (ERG) and electroencephalography (EEG), which are FDA-approved, noninvasive devices that measure electrical activity from the retina and brain using sensors placed on the skin around the eyes and scalp. Participants with Parkinson's disease will be tested before and after taking their prescribed Parkinson's medication (e.g., Sinemet® \[carbidopa/levodopa\]). Participants without Parkinson's disease will receive a single dose of compounded levodopa/carbidopa eye drops (an FDA-approved drug used in an unapproved ophthalmic formulation) in one eye and a placebo eye drop in the other eye. The placebo consists of the same vehicle solution without levodopa/carbidopa and contains 0.1% ascorbic acid, 0.001% benzalkonium chloride, and phosphate-buffered saline. Randomization will be used to determine which eye receives the levodopa/carbidopa eye drop and which eye receives the placebo. Researchers will compare measurements obtained before and after treatment to evaluate whether blue-light visual responses are associated with dopamine activity. | Parkinson | À vérifier | À vérifier | À vérifier | |
| Levodopa/Carbidopa (Sinemet)This study is being conducted at the Morsani College of Medicine to determine whether signals recorded from the eyes and brain can be used as a noninvasive way to monitor dopamine function. Approximately 50 adults (25 with Parkinson's disease and 25 without Parkinson's disease) will participate. Participants will undergo electroretinography (ERG) and electroencephalography (EEG), which are FDA-approved, noninvasive devices that measure electrical activity from the retina and brain using sensors placed on the skin around the eyes and scalp. Participants with Parkinson's disease will be tested before and after taking their prescribed Parkinson's medication (e.g., Sinemet® \[carbidopa/levodopa\]). Participants without Parkinson's disease will receive a single dose of compounded levodopa/carbidopa eye drops (an FDA-approved drug used in an unapproved ophthalmic formulation) in one eye and a placebo eye drop in the other eye. The placebo consists of the same vehicle solution without levodopa/carbidopa and contains 0.1% ascorbic acid, 0.001% benzalkonium chloride, and phosphate-buffered saline. Randomization will be used to determine which eye receives the levodopa/carbidopa eye drop and which eye receives the placebo. Researchers will compare measurements obtained before and after treatment to evaluate whether blue-light visual responses are associated with dopamine activity. | Parkinson | À vérifier | À vérifier | À vérifier | |
| MiaGB — Microbiome in Aging of Gut and BrainThe Microbiome in Aging Gut and Brain (MiaGB) Study is an observational study designed to examine whether differences in the microorganisms living in the gut and mouth are associated with cognitive health and cognitive decline. The study includes young healthy adults, cognitively healthy older adults, older adults with mild cognitive impairment (MCI), and older adults with Alzheimer's disease or related dementia. At the baseline visit, participants complete assessments of medical history, cognitive function, physical function, and diet and provide biological samples that may include stool, saliva, oral swabs, blood, and urine. Researchers will study the gut and oral microbiome and related biological factors, including metabolites and markers of intestinal permeability and inflammation, to determine whether these measures differ according to cognitive status. Young healthy adults, cognitively healthy older adults, and participants with MCI will be followed annually for up to 5 years to evaluate changes in the microbiome and cognitive function over time. Participants with Alzheimer's disease or related dementia will participate in the baseline assessment only. No drug, treatment, or other research intervention is assigned as part of this study. | Alzheimer | À vérifier | Immunomodulation | United States | À vérifier |
| PFM — Probiotic Milk Drink for Gut and Brain Health in Older Adults and CaregiversThis double-blind, randomized, placebo-controlled clinical trial will evaluate the effects of a probiotic fermented milk (PFM) drink on gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. Up to 40 participants will be enrolled. Participants will be randomly assigned to consume either the PFM drink or a matched placebo daily for 30 days. The primary objective is to determine whether PFM consumption improves gut microbiome abnormalities. Secondary objectives include evaluating effects on nutrient absorption, gut microbiome diversity and composition, and systemic inflammation. The study will also explore relationships between changes in nutrient absorption, microbiome profiles, inflammation, and behavioral outcomes in participants with ADRD and their caregivers. Each participant will participate in the study for approximately 30 days. This pilot study is intended to generate preliminary clinical and biological data regarding the potential role of probiotic nutrition in supporting gut and brain health and to inform the design of future larger clinical trials. | Alzheimer | Non applicable | Immunomodulation | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 1 | À vérifier | United States | À vérifier |
| ZavegepantProspective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials. | Migraine | Phase 1 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 2/3 | À vérifier | United States | À vérifier |
| Levadopa/Carbidopa eyedropsThis study is being conducted at the Morsani College of Medicine to determine whether signals recorded from the eyes and brain can be used as a noninvasive way to monitor dopamine function. Approximately 50 adults (25 with Parkinson's disease and 25 without Parkinson's disease) will participate. Participants will undergo electroretinography (ERG) and electroencephalography (EEG), which are FDA-approved, noninvasive devices that measure electrical activity from the retina and brain using sensors placed on the skin around the eyes and scalp. Participants with Parkinson's disease will be tested before and after taking their prescribed Parkinson's medication (e.g., Sinemet® \[carbidopa/levodopa\]). Participants without Parkinson's disease will receive a single dose of compounded levodopa/carbidopa eye drops (an FDA-approved drug used in an unapproved ophthalmic formulation) in one eye and a placebo eye drop in the other eye. The placebo consists of the same vehicle solution without levodopa/carbidopa and contains 0.1% ascorbic acid, 0.001% benzalkonium chloride, and phosphate-buffered saline. Randomization will be used to determine which eye receives the levodopa/carbidopa eye drop and which eye receives the placebo. Researchers will compare measurements obtained before and after treatment to evaluate whether blue-light visual responses are associated with dopamine activity. | Parkinson | À vérifier | À vérifier | À vérifier | |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 2 | À vérifier | China | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States, Canada, China, Czechia, Finland, Hungary, India, Italy, Japan, Poland, Slovakia, Spain | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 4 | À vérifier | United States, Israel | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States, Canada, France, Italy, Japan, Poland, Spain | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 4 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 1 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States, Argentina, Canada, China, Denmark, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, United Kingdom | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | À vérifier | À vérifier | United States | À vérifier |
| MiaGB — Microbiome in Aging of Gut and BrainThe Microbiome in Aging Gut and Brain (MiaGB) Study is an observational study designed to examine whether differences in the microorganisms living in the gut and mouth are associated with cognitive health and cognitive decline. The study includes young healthy adults, cognitively healthy older adults, older adults with mild cognitive impairment (MCI), and older adults with Alzheimer's disease or related dementia. At the baseline visit, participants complete assessments of medical history, cognitive function, physical function, and diet and provide biological samples that may include stool, saliva, oral swabs, blood, and urine. Researchers will study the gut and oral microbiome and related biological factors, including metabolites and markers of intestinal permeability and inflammation, to determine whether these measures differ according to cognitive status. Young healthy adults, cognitively healthy older adults, and participants with MCI will be followed annually for up to 5 years to evaluate changes in the microbiome and cognitive function over time. Participants with Alzheimer's disease or related dementia will participate in the baseline assessment only. No drug, treatment, or other research intervention is assigned as part of this study. | Alzheimer | À vérifier | Immunomodulation | United States | À vérifier |
| PFM — Probiotic Milk Drink for Gut and Brain Health in Older Adults and CaregiversThis double-blind, randomized, placebo-controlled clinical trial will evaluate the effects of a probiotic fermented milk (PFM) drink on gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. Up to 40 participants will be enrolled. Participants will be randomly assigned to consume either the PFM drink or a matched placebo daily for 30 days. The primary objective is to determine whether PFM consumption improves gut microbiome abnormalities. Secondary objectives include evaluating effects on nutrient absorption, gut microbiome diversity and composition, and systemic inflammation. The study will also explore relationships between changes in nutrient absorption, microbiome profiles, inflammation, and behavioral outcomes in participants with ADRD and their caregivers. Each participant will participate in the study for approximately 30 days. This pilot study is intended to generate preliminary clinical and biological data regarding the potential role of probiotic nutrition in supporting gut and brain health and to inform the design of future larger clinical trials. | Alzheimer | Non applicable | Immunomodulation | United States | À vérifier |
| RimegepantThe purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant). | Migraine | Phase 3 | À vérifier | China | À vérifier |
Essais cliniques
17| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Rimegepant | Migraine | Phase 3 | NCT05810038 | A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects. | COMPLETED |
| PFM — Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers | Alzheimer | Non applicable | NCT07800195 | PFM — Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers | NOT_YET_RECRUITING |
| MiaGB — Microbiome in Aging of Gut and Brain | Alzheimer | À vérifier | NCT07799402 | MiaGB — Microbiome in Aging of Gut and Brain | RECRUITING |
| Rimegepant | Migraine | À vérifier | NCT05198245 | Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy | ACTIVE_NOT_RECRUITING |
| Rimegepant | Migraine | Phase 3 | NCT03235479 | Safety and Efficacy Study in Adult Subjects With Acute Migraines | COMPLETED |
| Rimegepant | Migraine | Phase 3 | NCT03237845 | Safety and Efficacy in Adult Subjects With Acute Migraines | COMPLETED |
| Rimegepant | Migraine | Phase 3 | NCT03461757 | Trial in Adult Subjects With Acute Migraines | COMPLETED |
| Rimegepant | Migraine | Phase 3 | NCT06641466 | A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | RECRUITING |
| Rimegepant | Migraine | Phase 1 | NCT07667621 | A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department | NOT_YET_RECRUITING |
| Rimegepant | Migraine | Phase 4 | NCT05207865 | Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention | COMPLETED |
| Rimegepant | Migraine | Phase 3 | NCT07729462 | A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine | NOT_YET_RECRUITING |
| Rimegepant | Migraine | Phase 3 | NCT05156398 | Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects | RECRUITING |
| Rimegepant | Migraine | Phase 4 | NCT07609914 | A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine | RECRUITING |
| Rimegepant | Migraine | Phase 3 | NCT06616194 | A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine | ACTIVE_NOT_RECRUITING |
| Rimegepant | Migraine | Phase 2 | NCT07751497 | VERIFY — A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority Study | NOT_YET_RECRUITING |
| Levadopa/Carbidopa eyedrops | Parkinson | À vérifier | NCT07748715 | B3-4D — Brain Dopamine Biomarker | NOT_YET_RECRUITING |
| Rimegepant | Migraine | Phase 2/3 | NCT03266588 | Open Label Safety Study in Acute Treatment of Migraine | COMPLETED |
Publications
8| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Zavegepant | Real-world outcomes of zavegepant use in a tertiary care setting using the Migraine Treatment Optimization Questionnaire-5. | Headache | ||
| Zavegepant | Post Hoc Subgroup Analyses of the Efficacy and Safety of Zavegepant for the Acute Treatment of Migraine According to Baseline Triptan Experience. | Journal of pain research | ||
| Rimegepant | Halting neuron-fibroblast crosstalk disarms tumor and augments immunotherapy. | Trends in pharmacological sciences | ||
| Levodopa/Carbidopa (Sinemet) | The catechol-O-methyltransferase (COMT) inhibitor entacapone enhances the pharmacokinetic and clinical response to Sinemet CR in Parkinson's disease. | Journal of neurology, neurosurgery, and psychiatry | ||
| Rimegepant | Innovations in conservative and surgical therapy for Ménière's disease-narrative review. | Frontiers in neurology | ||
| Levodopa/Carbidopa (Sinemet) | The effect of levodopa or levodopa-carbidopa (sinemet) on fracture healing. | Journal of orthopaedic trauma | ||
| Levodopa/Carbidopa (Sinemet) | Pharmaceutical and pharmacokinetic evaluation of a newly formulated multiparticulate matrix of levodopa and carbidopa. | ADMET & DMPK | ||
| Rimegepant | Onabotulinumtoxin A Is an Effective Preventative Treatment of Chronic and Daily Pediatric Migraine. | Pediatric neurology |