Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning (NCT00418691) | Clinical Trial Compass
TerminatedPhase 3
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
Stopped: Closed early due to slow accrual.
United States34 participantsStarted 2004-02
Plain-language summary
Primary Objective:
* To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient diagnosed with a brain tumor, either primary or metastatic
. Patient had prior radiation treatment to the brain
. Patient is \> or = 18 years of age
. Patient has a Karnofsky performance status (KPS) performance of 70 at baseline
. Patient is using acceptable birth control methods. Female participants (if of child bearing age and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control, including abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization.
. Patient must speak and understand English or Spanish
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
Timeframe: Baseline to 4-5 weeks on study medication
2
Patient Cognitive Test Scores at End of Treatment Period
Timeframe: Baseline to end of Week 4 treatment period
. Patient has reported cognitive decline and is being considered for stimulant therapy by their neurologist
. Patient has provided written informed consent to participate in the study prior to enrollment to the study
Exclusion criteria
. History of hypersensitivity reaction to methylphenidate or modafinil
. History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, marked anxiety, tension or agitation
. History of clinically significant pulmonary or cardiac disease
. Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently greater than 140 mm Hg or diastolic pressure consistently greater than 90 mm Hg
. Patients with uncontrolled seizures will be excluded
. Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential
. Moderate to severe depression (\> 20 on Beck Depression Inventory II)
. If taking antidepressants, patient must be on a stable dose