Gocovri for Radiation Brain Injury

Overseen By Rajiv S Magge, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Amantadine, Dopaminergic, GABAergic, others

Disqualifiers: Pregnancy, Brain lesions, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

I am 18 years old or older.

My MRI shows significant white matter changes in the brain.

My caregiver can complete surveys for this study.

Exclusion Criteria

I am currently taking Amantadine or have taken it before.

My brain cancer is getting worse or needs more treatment.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Gocovri (extended-release amantidine) and undergo clinical and neuropsychological assessments

24 weeks

Regular office visits for medication adjustments and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gocovri

Trial Overview

The study tests if Gocovri (extended-release amantadine) can improve disabilities and cognition in patients with radiation-induced brain injury, using scales like the Disability Rating Scale (DRS) and Montreal Cognitive Assessment (MoCA).

How Is the Trial Designed?

Group I: Gocovri (extended-release amantidine) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Supernus Pharmaceuticals

Collaborator

Citations

1.

withpower.com

withpower.com/trial/phase-2-radiation-encephalopathy-8-2025-4ef8d

Gocovri for Radiation Brain Injury · Info for Participants

Trial Overview The study tests if Gocovri (extended-release amantadine) can improve disabilities and cognition in patients with radiation-induced brain injury, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04387773?term=AMANTADINE&rank=3

Effect of GOCOVRI (Amantadine, Extended Release ...

The purpose of the study is to learn about the effect of GOCOVRI ( Amantadine extended release) on activity levels and measures of gait and balance quality ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/b9096981fb243379/nct07125222-gocovri-improve-disability-radiation-encephalopathy

Use of Gocovri to Improve Disability Due to Radiation ...

A study to assess the effect of Gocovri (extended-release amantidine) to improve disability as assessed by the disability rating scale (DRS) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11274811/

Amantadine for Traumatic Brain Injury—Supporting Evidence ...

There is some robust, though limited, evidence that amantadine is effective and safe in the treatment of consequences of TBI. The results of the largest ...

5.

researchgate.net

researchgate.net/publication/352356337_A_placebo-controlled_randomized_clinical_trial_of_amantadine_hydrochloride_for_evaluating_the_functional_improvement_of_patients_following_severe_acute_traumatic_brain_injury

(PDF) A placebo-controlled randomized clinical trial of ...

Results: Although both groups had improvement in their DRS, the change from baseline was significantly better in the Amantadine group (10.88 ± ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07125222

Use of Gocovri to Improve Disability Due to Radiation ...

This is a prospective study to assess the effect of Gocovri (extended-release amantidine) on disability and cognition in patients with radiation ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf

GOCOVRI (amantadine) extended release capsules

Of the 100 patients in the safety population described below, 39 patients were treated with GOCOVRI for 24 weeks. The safety data for these trials were pooled.

8.

gocovrihcp.com

gocovrihcp.com/safety

Safety Profile | GOCOVRI® (amantadine)

POOLED SAFETY DATA. Schema showing hallucinations data from pivotal trials. Investigator rating: 13 (62%) as mild; 6 (29%) as moderate; 2 (10%) as severe.

9.

touchneurology.com

touchneurology.com/parkinsons-disease/journal-articles/development-efficacy-and-safety-of-once-daily-bedtime-extended-release-amantadine-gocovri-to-treat-dyskinesia-and-off-time-in-parkinsons-disease/

Development, Efficacy and Safety of Once-daily, Bedtime, ...

The safety profile of amantadine ER(Go) was acceptable; AEs of constipation, dizziness and hallucinations were more common with amantadine ER(Go) ...