Gocovri for Radiation Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Gocovri, a medicine designed to improve disability and thinking skills in people with brain injuries from radiation treatment. The researchers aim to determine if Gocovri can enhance daily life for those who have undergone brain radiation and now experience challenges such as memory problems or difficulty with daily tasks. It suits individuals who have had brain radiation, show noticeable brain changes on an MRI, and have a caregiver to assist with study surveys. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
You may need to stop taking certain medications to join this trial. Specifically, you cannot take Amantadine or other drugs that affect dopamine, GABA, glutamate, or norepinephrine.
Is there any evidence suggesting that Gocovri is likely to be safe for humans?
Studies have shown that Gocovri, a long-acting form of amantadine, is generally well-tolerated. In earlier trials, some participants experienced side effects such as constipation, dizziness, and hallucinations. Most hallucinations were mild, a few were moderate, and only a couple were severe.
The FDA has already approved Gocovri for other uses, indicating it has undergone sufficient study to be considered safe. This approval provides additional confidence in its safety. However, as with any treatment, discussing any concerns with a doctor is important.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for radiation brain injury, which typically involve corticosteroids and physical rehabilitation, Gocovri is unique because it utilizes extended-release amantadine. This feature allows for a more consistent and prolonged therapeutic effect, potentially offering better management of symptoms such as cognitive and motor impairments. Researchers are excited about Gocovri because it targets neurotransmitter imbalances in the brain, which might address the root causes of symptoms more effectively than current options. Additionally, Gocovri's convenient dosing schedule could improve patient adherence compared to more frequent medication regimens.
What evidence suggests that Gocovri might be an effective treatment for radiation brain injury?
Studies have shown that Gocovri, a long-acting form of amantadine, can enhance physical abilities and cognitive skills in individuals with brain injuries. Research has indicated that amantadine is effective and safe for treating symptoms related to traumatic brain injuries (TBI), which resemble brain injuries caused by radiation. In one study, patients taking amantadine demonstrated significantly better improvements in their disability scores compared to those not receiving the treatment. This trial will assess whether Gocovri might also benefit individuals with radiation-related brain injuries, potentially enhancing their daily activities and mental abilities.36789
Who Is on the Research Team?
Rajiv S Magge, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for individuals who have experienced brain injury due to radiation therapy. Participants should be able to complete cognitive assessments and have a measurable level of disability from the encephalopathy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Gocovri (extended-release amantidine) and undergo clinical and neuropsychological assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gocovri
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Supernus Pharmaceuticals
Collaborator