Health TrialsbyHealthPanel

Use of Gocovri to Improve Disability Due to Radiation Encephalopathy

ConditionsEncephalopathyRadiation Effect
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Gocovri (extended-release amantidine)Experimental treatment 1 intervention

Trial outcomes

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).

Time frame
Baseline - 24 weeks.

Secondary outcomes

1

Change in cognition based on the MoCA test.

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.

Time frame
Baseline - 24 weeks.
2

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

Time frame
Baseline - 24 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: