Use of Gocovri to Improve Disability Due to Radiation Encephalopathy

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07125222
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Radiation Encephalopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gocovri (extended-release amantidine)

Primary Outcome Measure

Change in the level of disability as measured by the Disability Rating Scale(DRS) [ Time Frame: Baseline - 24 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Rajiv S Magge, MD
[email protected]
Rajiv S Magge, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY