Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359723
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2006-07-31
Brief Title:
Methylphenidate and Parkinsons Disease
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Subacute Trial of Methylphenidate in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to determine if methylphenidate MPD a drug marketed in the US to treat hyperactivity and narcolepsy added to levodopa will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinsons disease PD
Detailed Description:
Parkinsons disease PD is a common disorder caused by the loss of dopamine-producing brain cells The disorder is generally treated with levodopa combined with carbidopa Nerve cells use levodopa to make dopamine Carbidopa delays the conversion of levodopa into dopamine until it reaches the brain Motor fluctuations the wearing off effects of levodopa characterized by sometimes rapid changes between uncontrolled and normal movements are a common and often difficult to manage source of disability in people with PD
In this trial researchers will study the effects of methylphenidate MPD also known as Ritalin-a drug marketed in the US to treat hyperactivity and narcolepsy-on carbidopalevodopa and other antiparkinson medications taken orally by individuals with Parkinsons disease who experience motor fluctuations when they take levodopa The overall goal of this project is to develop better symptomatic therapies for PD
After 2 screening visits to the treatment clinic to evaluate the wearing on and off effects of levodopa eligible participants will be scheduled for 3 admissions to the General Clinical Research Center at Oregon Health Science University during which they randomly will receive the study drug MPD or placebo along with their usual carbidopalevodopa therapy andor other antiparkinson medications Also participants will have their parkinsonism tremor rigidity postural instability and bradykinesia rated and blood pressure and pulse measured at regular intervals
Duration of the study for participants is about 3 weeks and includes 2 outpatient clinic visits for screening and 3 inpatient clinic visits with overnight stays
In this trial researchers will study the effects of methylphenidate MPD also known as Ritalin-a drug marketed in the US to treat hyperactivity and narcolepsy-on carbidopalevodopa and other antiparkinson medications taken orally by individuals with Parkinsons disease who experience motor fluctuations when they take levodopa The overall goal of this project is to develop better symptomatic therapies for PD
After 2 screening visits to the treatment clinic to evaluate the wearing on and off effects of levodopa eligible participants will be scheduled for 3 admissions to the General Clinical Research Center at Oregon Health Science University during which they randomly will receive the study drug MPD or placebo along with their usual carbidopalevodopa therapy andor other antiparkinson medications Also participants will have their parkinsonism tremor rigidity postural instability and bradykinesia rated and blood pressure and pulse measured at regular intervals
Duration of the study for participants is about 3 weeks and includes 2 outpatient clinic visits for screening and 3 inpatient clinic visits with overnight stays
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS021062 | NIH | None | httpsreporternihgovquickSearchR01NS021062 |