The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Institute of Global Health and Infectious Disease

Clinical Research Center

Reunion Neuroscience

In this study, researchers will learn for the first time about the safety of a study drug called BIIB145 and how the body responds to it. This is a "Phase 1" study. This kind of study is an early step in clinical research where the goal is to focus on the safety of the study drug. Another goal may be to learn how the study drug is processed by the body. BIIB145 was designed to help people with multiple sclerosis (MS). But, before it can be tested in people with MS, it must first be tested in healthy volunteers to learn about its safety and other effects.

The main goal of this study is to learn about the safety of BIIB145 and how it is processed by the body, with or without food.

The main questions researchers want to answer are:

* How many participants have adverse events and serious adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug.
* How does BIIB145 affect the participants' overall health?

Researchers will also learn more about:

* How BIIB145 is processed by the body, with or without food.

This study will be done as follows:

* Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into the study research center.
* There will be 3 parts to this study.
* Part 1: Participants will take a single dose of BIIB145 or a placebo after not eating overnight. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. Participants in Part 1 will be in the study for up to 42 days.
* Part 2: This part of the study will have a "crossover" design. This means that all participants in Part 2 will all take BIIB145 twice, once with food and once without food. When taken with food, they will finish a meal about 30 minutes before their dose. Without food, they will not eat overnight before taking their dose. But, the order in which they take BIIB145 with or without food depends on the group to which they are randomly assigned. Participants in Part 2 will be in the study for up to 56 days.
* Part 3: Participants will take a dose of BIIB145 or the placebo once a day for 14 days. For each dose, participants will not eat overnight before taking it. Participants in Part 3 will be in the study for up to 56 days.
* For Part 1, participants will stay at the study research center for 4 days after screening. There will be 2 other visits to the center to check on participants' health on Day 7 and Day 14.
* For Part 2, at 2 different times, participants will stay at the center for a period of 4 days at a time, after screening. There will be a break of about 7 days between stays. There will be 3 other visits to the center to check on their health on Day 7 (of each period) and on Day 14.
* For Part 3, participants will stay at the center for 17 days after screening. There will be 2 other visits to the center to check on their health on Day 21 and Day 28.

A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants

Biogen

The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Hulse Spinal Cord Injury Lab

SetPoint Medical

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

ARC Far West Medical Tower

Naples, FL

Raleigh, NC

Clinical Research Department

Novartis

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Find clinical trials for Multiple Sclerosis (MS) in Austin, TX

Related conditions:

Multiple Sclerosis (MS) trials near Austin, TX, USA:

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Find clinical trials for Multiple Sclerosis (MS) in .css-epvm6{white-space:nowrap;}Austin, TX

Related conditions:

Multiple Sclerosis (MS) trials near Austin, TX, USA:

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Find clinical trials for Multiple Sclerosis (MS) in Austin, TX