Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT03194906
Eligibility Criteria:
Inclusion Criteria:
* Age 6 years to 21 years at time of study enrollment
* Diagnosis of localized low grade glioma \[e.g., pilocytic astrocytoma, optic pathway glioma, ogligodendroglioma, ganglioglioma, pleomorphic xanthoastrocytoma (PXA)\], craniopharyngioma, ependymoma, or germ cell tumor
* Initiating focal cranial radiation therapy (photon or proton)
* Laboratory tests \[transaminases (ALT, AST, ALP), BUN and creatinine not greater than twice normal\] and normal ECG
* Speak, read and understand English sufficiently to complete study assessments
* Adequate vision and hearing for valid completion of study measures
* Negative βHCG pregnancy test among females of childbearing age
* Participant must be able to swallow pills (psychology staff will be available to assist with pill swallowing training if needed)
* Parent/Legal guardian available and able to speak, read and understand English
Exclusion Criteria:
* Medical disorder that would endanger subject's well-being (e.g., uncorrected hypothyroidism, cardiac arrhythmia, hypertension requiring treatment, sick sinus syndrome, prolonged QTc)
* History of significant neurological disease including poorly controlled seizures (i.e., \> 1 seizure per month; anti-epileptic medications are acceptable), stroke, or head injury with loss of consciousness
* Psychiatric condition that would preclude or take precedence over study participation (e.g., active psychosis, suicidal ideation)
* IQ below 70 based on baseline/screening assessment
* Treatment with psychotropic medication (psychostimulant, antidepressant, anxiolytic, antipsychotic) within the past two weeks, unless being prescribed specifically as an anti-emetic
* History of substance abuse
* History of hypersensitivity or reaction to NMDA receptor antagonists
* History of prior cranial radiation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT03194906
Study Brief:
Protocol Section:
NCT03194906