Type Condition

Holly Hill, FL

203 Clinical Trials near Holly Hill, FL

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Pentosan Polysulfate Sodium for Osteoarthritis

Daytona Beach, Florida
The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

466 Participants Needed

Ofatumumab for Multiple Sclerosis

Ormond Beach, Florida
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

180 Participants Needed

Radiation Therapy for Cancer with Bone Metastasis

Daytona Beach, Florida
This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

280 Participants Needed

Buntanetap for Alzheimer's Disease

Daytona Beach, Florida
The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are: * Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13? * Does buntanetap/Posiphen improve function as measured by ADCS-iADL? * What medical issues do participants have, if any, when taking buntanetap/Posiphen? Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease. Participants will: * Take buntanetap/Posiphen or a placebo every day for 18 months * Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18 * Complete pre- and post-clinic visit phone calls
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 85

760 Participants Needed

Zasocitinib for Psoriatic Arthritis

Ormond Beach, Florida
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

1088 Participants Needed

BI 690517 + Empagliflozin for Heart Failure

Daytona Beach, Florida
This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

6000 Participants Needed

Retatrutide vs Semaglutide for Type 2 Diabetes

Daytona Beach, Florida
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

1250 Participants Needed

Cretostimogene Grenadenorepvec for Bladder Cancer

Daytona Beach, Florida
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

367 Participants Needed

Remibrutinib vs Teriflunomide for Multiple Sclerosis

Daytona Beach, Florida
This trial compares remibrutinib and teriflunomide in patients with relapsing multiple sclerosis. It aims to find out which medication is more effective and safer. Both drugs work by controlling the immune system to reduce relapses. Teriflunomide is an approved treatment for adults with this condition.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55

800 Participants Needed

Olanzapine vs Megestrol Acetate for Cancer-Related Anorexia

Ormond Beach, Florida
This trial tests whether olanzapine or megestrol acetate is better at increasing appetite in patients with advanced cancer. These patients often struggle with eating and weight loss. Both medications aim to make them feel hungrier, helping them eat more and gain weight. Megestrol acetate is known for its effectiveness in increasing appetite in patients with cancer.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

360 Participants Needed

Tirzepatide + Retatrutide for Fatty Liver Disease

Daytona Beach, Florida
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

4500 Participants Needed

Olpasiran for Cardiovascular Disease

Ormond Beach, Florida
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:50+

11000 Participants Needed

IMVT-1402 for Myasthenia Gravis

Ormond Beach, Florida
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

231 Participants Needed

Maridebart Cafraglutide for Heart Failure

Ormond Beach, Florida
This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

5056 Participants Needed

Retatrutide for Chronic Low Back Pain

Daytona Beach, Florida
The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

586 Participants Needed

Vicadrostat + Empagliflozin for Heart Failure

Daytona Beach, Florida
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between 1 and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

4200 Participants Needed

CYB704 vs Ocrevus for Multiple Sclerosis

Ormond Beach, Florida
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will: * Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU) * Visit the clinic for at least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55

175 Participants Needed

Bimekizumab for Psoriatic Arthritis

Ormond Beach, Florida
The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

684 Participants Needed

KarXT for Psychosis in Alzheimer's Disease

Daytona Beach, Florida
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90

406 Participants Needed

AD109 for Obstructive Sleep Apnea

Daytona Beach, Florida
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 3

1280 Participants Needed

Why Other Patients Applied

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

ACP-204 for Alzheimer's Disease

Daytona Beach, Florida
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:55 - 95

1074 Participants Needed

Dazodalibep for Sjögren's Syndrome

Ormond Beach, Florida
This trial is testing dazodalibep, a medication, to see if it can help people with moderate-to-severe Sjögren's Syndrome. The goal is to reduce their symptoms and improve their quality of life. Researchers will also check if the medication is safe and well-tolerated by patients.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

651 Participants Needed

KarXT for Alzheimer's-Related Psychosis

Ormond Beach, Florida
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027, CN012-0056 or CN012-0034. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study, 14-week CN012-0056 or 14 week CN012-0034 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT and KarXT + KarX-EC in subjects with psychosis associated with Alzheimer's Disease.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90

800 Participants Needed

ADT + Apalutamide for Prostate Cancer

Daytona Beach, Florida
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male

420 Participants Needed

Upadacitinib for Lupus

Daytona Beach, Florida
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. 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, checking for side effects and completing questionnaires.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 63

1000 Participants Needed

Upadacitinib vs Adalimumab for Rheumatoid Arthritis

Daytona Beach, Florida
This trial is testing two medications, upadacitinib (a daily pill) and adalimumab (an injection), for adults with rheumatoid arthritis who haven't responded to other treatments. The study aims to see which drug is safer and more effective. Both medications work by reducing inflammation through different mechanisms in the immune system. Adalimumab, an injection, has been extensively studied and used for treating rheumatoid arthritis, showing significant improvements in patients who have not responded to other treatments.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

487 Participants Needed

AD109 for Obstructive Sleep Apnea

Daytona Beach, Florida
This trial is testing a specific combination of medications called AD109 to see if it helps people with Obstructive Sleep Apnea. The goal is to find out if AD109 can keep airways open during sleep. The study will last for several months and compare the effects of AD109.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

660 Participants Needed

Milvexian vs Apixaban for Atrial Fibrillation

Daytona Beach, Florida
This trial is testing a new medication called milvexian to see if it can prevent strokes and blood clots as well as an existing drug, apixaban. Apixaban (Eliquis™) was developed by Bristol-Myers Squibb and Pfizer and has been approved for the prevention of stroke in patients with certain heart conditions. The study focuses on patients who are at risk of these serious conditions. Milvexian works by helping to keep the blood flowing smoothly, reducing the chances of dangerous clots forming.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

20296 Participants Needed

Inclisiran for Cardiovascular Disease Prevention

Daytona Beach, Florida
This trial tests whether inclisiran injections can prevent serious heart problems in high-risk adults who haven't had a major heart event yet by lowering their cholesterol levels. Inclisiran is a long-acting treatment that significantly lowers cholesterol.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40 - 79

14082 Participants Needed

Abelacimab for Atrial Fibrillation

Ormond Beach, Florida
This trial is testing abelacimab, a medication aimed at preventing strokes and blood clots in people with Atrial Fibrillation. These patients are either unsuitable for or have chosen not to use common medications for thinning blood. Abelacimab works by reducing the blood's ability to form dangerous clots.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:65+

1900 Participants Needed

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