Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418691
Status:
TERMINATED
Last Update Posted:
2020-09-23
First Post:
2007-01-03
Brief Title:
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Assessing the Efficacy of Immediate Release Methylphenidate Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed early due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
All three drugs used in this clinical research study are widely used stimulants to help cancer patients who have fatigue and problems with concentration
Before treatment starts you will have a physical exam including measurement of blood pressure and neuropsychological and symptom evaluations The neuropsychological evaluation is made up of tests of attention memory speech and other brain functions and takes about 30 minutes to complete The other test evaluates symptoms you may be experiencing such as fatigue or depression and takes about 10 minutes to complete
You will be randomly assigned as in the toss of a coin to one of three treatment groups Participants in the first group will receive Immediate Release IR methylphenidate Participants in the second group will receive Sustained Release SR methylphenidate Participants in the third group will receive modafinil There is an equal chance of being assigned to any of the groups After you are randomized you will contact the M D Anderson pharmacy to receive your assigned medication You will receive a total of 5 weeks worth of medication The extra week of medication is to allow for buffer should there be any conflict in rescheduling the follow-up evaluation
IR methylphenidate is a pill taken twice a day Both SR methylphenidate and modafinil are pills taken once a day The amount of the medicine is the same for all three groups You will take the medication every day for a total of 4 weeks
You will be asked to complete a study calendar which will be provided by the research staff In the study calendar you will be asked to initial after you take the study drug each day and to record any side effects you may experience You will be required to return the completed study calendar at the final evaluation visit along with the empty bottles and any of the study drugs that may be left over
You will remain on treatment for 4 weeks and return for a final evaluation A follow-up neuropsychological evaluation and evaluation of symptoms will be performed At the end of the study treatment period you will be allowed to remain on active treatment if you wish to You can discuss with your doctor whether to continue on the same medication or to try another one
This is an investigational study All of the study drugs are FDA approved and currently are used to help brain tumor patients A total of 75 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will have a physical exam including measurement of blood pressure and neuropsychological and symptom evaluations The neuropsychological evaluation is made up of tests of attention memory speech and other brain functions and takes about 30 minutes to complete The other test evaluates symptoms you may be experiencing such as fatigue or depression and takes about 10 minutes to complete
You will be randomly assigned as in the toss of a coin to one of three treatment groups Participants in the first group will receive Immediate Release IR methylphenidate Participants in the second group will receive Sustained Release SR methylphenidate Participants in the third group will receive modafinil There is an equal chance of being assigned to any of the groups After you are randomized you will contact the M D Anderson pharmacy to receive your assigned medication You will receive a total of 5 weeks worth of medication The extra week of medication is to allow for buffer should there be any conflict in rescheduling the follow-up evaluation
IR methylphenidate is a pill taken twice a day Both SR methylphenidate and modafinil are pills taken once a day The amount of the medicine is the same for all three groups You will take the medication every day for a total of 4 weeks
You will be asked to complete a study calendar which will be provided by the research staff In the study calendar you will be asked to initial after you take the study drug each day and to record any side effects you may experience You will be required to return the completed study calendar at the final evaluation visit along with the empty bottles and any of the study drugs that may be left over
You will remain on treatment for 4 weeks and return for a final evaluation A follow-up neuropsychological evaluation and evaluation of symptoms will be performed At the end of the study treatment period you will be allowed to remain on active treatment if you wish to You can discuss with your doctor whether to continue on the same medication or to try another one
This is an investigational study All of the study drugs are FDA approved and currently are used to help brain tumor patients A total of 75 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None