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NCT Number: NCT07125222

Use of Gocovri to Improve Disability Due to Radiation Encephalopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location contact

Rajiv S Magge, MD

CONTACT

[email protected]

Rajiv S Magge, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gocovri (extended-release amantidine)

Drug

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 outcomes

  1. Change in the level of disability as measured by the Disability Rating Scale(DRS)

    Time frame: Baseline - 24 weeks.

    The Disability Rating Scale (DRS) is a tool used to evaluate impairment, disability and handicap caused by brain injury. Scores range from 0 (No disability) to a maximum of 29 (indicating an extreme vegetative state).

Secondary outcomes

  1. Change in cognition based on the MoCA test.

    Time frame: Baseline - 24 weeks.

    The Montreal Cognitive Assessment (MoCA) is a brief screening tool to assess cognitive function and identify potential cognitive impairment. A score of 26-30 is considered normal, 18-25 as mild cognitive impairment, 10-17 as moderate cognitive impairment and below 10 as severe cognitive impairment.

  2. Change in 18F-FPEB avidity on PET/CT.

    Time frame: Baseline - 24 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Rajiv S Magge, MD

CONTACT

[email protected]

646-962-2185

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Supernus Pharmaceuticals

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.