Clinical Trials Directory
We are doing this study to find out if the combination of an experimental drug called ONC201 (the study drug) with paxalisib is an effective option for patients with a diffuse midline glioma (DMG). We also want to see how much of these drugs are absorbed by tumor tissue in patients with brain tumors.
This study is for people with type 1 diabetes (T1D). Their immune system attacks cells in the body that make insulin. A new treatment called GNTI-122 is made from their own blood cells and may help stop this attack. People will be in one of three groups: low dose, high dose, or high dose with another medicine called rapamycin. The study includes several visits to check if the treatment works and is safe.
The person in the study will take part for about 5 years and 2 months. During this time, doctors will check their health in many ways. These checks include a physical exam, blood tests, breathing tests, heart tests, muscle scans, and other special tests. The study has four parts: 1. First, there is a screening visit to make sure the person can join. 2. Next, the person will get the study medicine. 3. Then, there is an active observation period for 1 year. During this time, there will be about 19 visits at home and at the clinic. 4. Finally, there is a long-term follow-up for 4 years. This part has 8 visits.
If people join this study, they will first have tests to see if they can take part. If they qualify, they will be placed into one of two groups by chance. Most participants will receive a new medicine called OCS 05, while a smaller number will receive a placebo, which has no active medicine. Neither the participants nor the study doctors will know which treatment is being given. Everyone in the study will receive the standard treatment for optic neuritis, which is a steroid medicine given through a vein. In addition, participants will receive either OCS 05 or the placebo through a vein once a day for five doses. The study lasts about one year. During that time, participants will have regular visits for eye exams, vision tests, brain scans, neurological exams, and safety checks. Researchers want to learn if OCS 05 is safe and if it can help protect vision and improve recovery in people with optic neuritis.
Participants will attend 7 visits at Duke Medical Center. They will first complete a training visit, then have 2 MRI visits about 1 to 4 weeks apart. Between the MRI visits, participants will attend up to 5 treatment visits on consecutive days. The study is testing a noninvasive treatment called transcranial magnetic stimulation (TMS) to see if it may help treat fibromyalgia.