NCT07125222

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
23mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

August 8, 2025

Last Update Submit

July 30, 2026

Conditions

EncephalopathyRadiation Effect

Keywords

Radiation encephalopathyAmantadineGocovri

Outcome Measures

Primary Outcomes (1)

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

    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).

    Baseline - 24 weeks.

Secondary Outcomes (2)

  • Change in cognition based on the MoCA test.

    Baseline - 24 weeks.

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

    Baseline - 24 weeks.

Study Arms (1)

Gocovri (extended-release amantidine)

EXPERIMENTAL
Drug: Gocovri (extended-release amantidine)

Interventions

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.

Gocovri (extended-release amantidine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Rajiv S Magge, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajiv S Magge, MD

CONTACT

646-962-2185ram9116@med.cornell.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 15, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)