Use of Gocovri to Improve Disability Due to Radiation Encephalopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gocovri (extended-release amantidine).
- Who it may be relevant to
- Registry conditions: Encephalopathy, Radiation Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A study to assess the effect of Gocovri (extended-release amantidine) to improve disability as assessed by the disability rating scale (DRS) and cognition as assessed by the Montreal Cognitive Assessment (MoCA) test in patients with radiation encephalopathy.
Detailed description
This is a prospective study to assess the effect of Gocovri (extended-release amantidine) on disability and cognition in patients with radiation encephalopathy. Patients with radiation encephalopathy will be seen in the office, and both clinical and short structured neuropsychological assessments will be collected longitudinally as medication adjustments are performed over time. The investigators will also measure functional glutamate activity in these subjects through use of F-FPEB PET/CT, which identifies mGluR5 expression in the brain. This imaging tracer serves as a surrogate for neurodegeneration in other conditions, such as Parkinson's Disease.
Interventions
- Drug Gocovri (extended-release amantidine)
Gocovri is extended release formulation of amantidine. Starting on Day 1, patients will start Gocovri 137mg daily. If there is no dose-limited event after 28 days, the dose will be increased to 274mg daily which will become the new standard dose for the remaining 20 weeks of the patient's participation in the study.
Primary outcome measures
- Change in the level of disability as measured by the Disability Rating Scale(DRS) [Time frame: Baseline - 24 weeks.]
Secondary outcome measures (2)
- Change in cognition based on the MoCA test. [Time frame: Baseline - 24 weeks.]
- Change in 18F-FPEB avidity on PET/CT. [Time frame: Baseline - 24 weeks.]
Eligibility criteria
Inclusion criteria
- Individuals ≥ 18 years of age.
- Individuals with caregivers who are able to complete survey assessments for this study.
- Prior brain radiation treatment.
- Evidence of moderate-severe confluent white matter hyperintensity on MRI brain scan as judged by neuroradiology impression 0-5 years prior to enrollment.
- DRS > 6
- The effects of Gocovri on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; female subjects will be required to demonstrate a negative urine pregnancy test prior to study entry and subjects who are lactating should be excluded.
Exclusion criteria
- Pregnant or breastfeeding.
- Patients with growing brain lesions or those requiring escalating doses of tumor-directed treatment..
- Patients requiring doses of Dexamethasone higher than 4 mg or escalating doses of Dexamethasone
- Patients taking Amantadine or with prior usage of Amantadine.
- Patients taking other dopaminergic, GABAergic, glutamatergic, or noradrenergic drugs.
- Patients with a history of suicidality and depression.
- Patients with end stage renal disease (creatinine clearance less than 15 mL/min/1.73 m2).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT07125222 · 23-10026601