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SUNY Downstate Clinical Trial Office provides a wide spectrum of research opportunities for the promotion of innovative and quality healthcare within the Brooklyn community. These services include numerous clinical trials that explore new medications, treatments and therapeutic devices that may help our patients dealing with a wide variety of diseases.

What Is a Clinical Trial?

A clinical trial is a thorough and carefully controlled evaluation of a new medical test or treatment.

A clinical trial is a health-related research study in human beings that follows a pre-defined protocol. Interventional studies aim to answer specific questions about new therapies or new ways of using known treatments, while observational studies are those in which patients are observed and their outcomes are measured by the investigators. Carefully conducted clinical trials are the safest and most efficient way to identify treatments that work in people.

Before a clinical trial begins, the treatment must show that it has potential benefit. It also must meet rigorous government standards and scientific requirements for safety and have acceptable side effects before the study can be done on humans.

Ultimately, the only way to determine the true benefit and safety of a treatment is to test it on people with the disease or condition for which the treatment was developed. Clinical trials are one of the steps in determining how effective a drug or treatment is in improving the outcome a disease or medical condition.

Examples of What a Clinical Trial May Investigate:

  • New treatments (drug or devices)
  • New ways to use existing treatments
  • New screening and diagnostic techniques
  • Healthy participants only
  • Participants with specific illnesses/conditions

 

Why Do We Have Clinical Trials?

Due to improvements in medical treatments, many more patients are surviving serious illnesses that they might not have years ago. These improvements were accomplished through research, both in the laboratory and in the clinical setting. However, there are still many questions to be answered about treatments for patients and the care they receive. Finding answers to these questions is why research is an essential part of SUNY Downstate.

 

Types of Clinical Trials

There are many different types of clinical trials and many ways patients and their families can participate. A clinical trial can:

  • Compare two medications or treatments to learn which works better for patients
  • Examine how well a medication works and what side effects may occur
  • Observe the general condition of the patient to learn about a specific disease process or group of symptoms, and how they affect patients
  • Test new medical devices

Clinical Trials Open to Enrollment

Please review the following disciplines for available clinical trials. If interested in a trial, contact information is provided.

Treatment of Social Communication and Language Deficits with Leucovorin for Young Children with ASD

Study to treat young children with ASD with Leucovorin - Full Text View - ClinicalTrials.gov (NCT # 04060030)

Harris Huberman, MD
(718) 270-4657

Early Treatment of Language Impairment in Young Children with Autism Spectrum Disorder with Levoleucovorin

NCT# 04060017

Harris Huberman, MD
(718) 270-4657

S Nocturia Associated With an Abnormal Valsalva Maneuver Blood Pressure Response 

Jason Lazar, MD
(718) 270-1568

We Care About Brooklyn (WeCAB)

A Digitital Behavioral Intervention to Optimize Engagement in Maternal Healthcare

NCT# 05916534

Aimee Afable, PhD
(718) 270-6937

(INCB 18424-312): A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

NCT#06548360

Jeannette Jakus, MD

Coordinator: Beatrice Wojuola
718-270-1229

Beta Cell Function in Type 2 diabetes in Black Patients: Differential Metabolic Effects of GLP-1 Receptor Agonists and SGLT-1 inhibitors

Maryann Banerji, MD
718-270-4697 x4693

Coordinator:  (718) 270-4693

Human Immunology Biosciences, Inc. (HI-Bio) / “An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis

NCT # NCT06064929

Subodh Saggi, MD
(718) 270-1565

Coordinator: (718) 221-6594

An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmocokinetics, and Pharmadynamics of Different Dose Levels of Povetacicept in Subjects with Autoantibody  Associated Glomerular Diseases (RUBY-3) 

NCT # 05732402

Subodh Saggi, MD
(718) 270-1565

Coordinator: (718) 221-6594

A Phase 2/3 Adaptive, Double-blind, PlaceboControlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease

NCT # 05312879

Subodh Saggi, MD
(718) 270-1565

Coordinator: (718) 221-6594

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

Steve Levine, MD
(718) 270-3188

Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

NCT # 05047172

Nikolaos Papamitsakis, MD
Coordinator: (718) 270-7786

Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination with Gemcitabine in Subjects with Recurrent / Refractory Metastatic Advanced Pancreatic Cancer

NCT# 06030622

Mohan Preet, MD
(718) 270-1500

Coordinator:  (718) 270-1290; (718) 221-6594 

(TEN-01-304) A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Pediatric Patients 12 to Less than 18 Years Old

NCT # 05643534

Thomas Wallach, MD
Coordinator: 718-270-1364