Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
Stopped early · Phase 3
Conditions studied: Brain Tumor
In brief
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.
Key facts
- Study ID
- NCT00418691
- Run by
- M.D. Anderson Cancer Center
- People needed
- 34
- Starts
- 2004-02-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2020-09-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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
- Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or anticoagulants
- Current use of the following herbals or supplements for fatigue relief (dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St. John's Wort)
- Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate. Any potential interactions or coexisting medical condition not specified by the protocol will be determined by the prescribing physician as being exclusionary or not.
- Patients currently taking any erythropoietin type drugs
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.