Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459420
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2007-04-11
Brief Title:
Caffeine for Excessive Daytime Somnolence in Parkinsons Disease
Sponsor:
Ron Postuma
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Caffeine for Excessive Daytime Somnolence in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Many patients with Parkinsons disease PD have sleep problems including excessive sleepiness during the day This is probably due to degeneration of sleep-regulating areas in the brain At present the only treatment for sleepiness in PD is modafinil which is expensive and only partially effective There is another potential treatment for sleepiness that is used worldwide is inexpensive well tolerated and safe - namely caffeine There have also been suggestions that caffeine may slow the progression of degeneration in PD since coffee non-drinkers are at higher risk of developing PD PD patients even with severe sleepiness often do not use caffeine It is unclear whether this is because their PD makes their sleepiness unresponsive to caffeine because they cannot tolerate it or whether this reflects their lifelong habit of non-use This proposal outlines a trial in which patients with excessive sleepiness will be given caffeine or placebo no therapy in a blinded fashion In this way the effect of caffeine on sleepiness and motor symptoms can be directly analyzed In addition these findings can be used to test the tolerability of caffeine to help plan a larger-scale study testing whether caffeine can slow the progression of PD
Detailed Description:
Parkinsons disease PD is a common neurodegenerative disorder characterized by motor disability and many disabling non-motor symptoms Excessive daytime somnolence EDS is found in up to 50 of patients with PD and can cause considerable impairment of quality of life At present the only proven treatment for EDS in PD is modafinil an alerting agent with an unknown mechanism of action However modafinil is only moderately effective and is very expensive Caffeine is a very well tolerated and inexpensive alerting agent that is used worldwide but very few patients with PD use it as therapy for EDS It is unclear whether this is because it does not help EDS in PD has side effects or simply has not been considered because of lifelong patterns of non-use
If caffeine can be demonstrated as an effective agent for EDS in PD it will likely become the first-line agent for EDS This will result in considerable cost savings for patients and health care payers as well as potentially helping those who cannot tolerate do not respond to or cannot afford modafinil
Another compelling question of interest to patients with PD is whether caffeine may be neuroprotective Despite intensive research no treatment has been found that can slow the progression of neurodegeneration in PD Recently numerous epidemiologic studies have linked lifelong use of caffeine to a lower risk of PD Although the mechanism for this finding is unclear supporting evidence from animal models suggests that a true neuroprotective benefit of caffeine is a strong possibility Alternatively caffeine could have a benefit on motor manifestations of PD which would prevent diagnosis of PD Any finding of a symptomatic benefit of caffeine on motor manifestations of PD will have obvious and important implications for treatment of persons affected with PD and for planning of neuroprotective trials Any finding of a neuroprotective benefit of caffeine will almost certainly result in its immediate widespread use in PD with profound implications for patient care
The present proposal is for a double blind randomized placebo controlled crossover trial that will answer three important questions in PD is caffeine useful for the treatment of EDS in patients with PD does caffeine have any symptomatic effect on the motor manifestations of PD and does caffeine have an acceptable tolerability and side effect profile that will allow planning of an eventual neuroprotective trial Patients with PD who have EDS with an Epworth sleepiness scale of 10 will be randomized to caffeine therapy 100 mg twice per day for three weeks then 200 mg twice per day for three weeks or placebo A final assessment will be performed after a 4-week washout A total of 52 patients will be randomized over a two-year period The primary outcome measure will be the change in Epworth sleepiness scale between patients receiving caffeine versus placebo Secondary outcome measures will include other sleep scales tolerability measures and measures of motor function and overall quality of life After tests to assess normal distribution analysis will be with two-sample t-test
If caffeine can be demonstrated as an effective agent for EDS in PD it will likely become the first-line agent for EDS This will result in considerable cost savings for patients and health care payers as well as potentially helping those who cannot tolerate do not respond to or cannot afford modafinil
Another compelling question of interest to patients with PD is whether caffeine may be neuroprotective Despite intensive research no treatment has been found that can slow the progression of neurodegeneration in PD Recently numerous epidemiologic studies have linked lifelong use of caffeine to a lower risk of PD Although the mechanism for this finding is unclear supporting evidence from animal models suggests that a true neuroprotective benefit of caffeine is a strong possibility Alternatively caffeine could have a benefit on motor manifestations of PD which would prevent diagnosis of PD Any finding of a symptomatic benefit of caffeine on motor manifestations of PD will have obvious and important implications for treatment of persons affected with PD and for planning of neuroprotective trials Any finding of a neuroprotective benefit of caffeine will almost certainly result in its immediate widespread use in PD with profound implications for patient care
The present proposal is for a double blind randomized placebo controlled crossover trial that will answer three important questions in PD is caffeine useful for the treatment of EDS in patients with PD does caffeine have any symptomatic effect on the motor manifestations of PD and does caffeine have an acceptable tolerability and side effect profile that will allow planning of an eventual neuroprotective trial Patients with PD who have EDS with an Epworth sleepiness scale of 10 will be randomized to caffeine therapy 100 mg twice per day for three weeks then 200 mg twice per day for three weeks or placebo A final assessment will be performed after a 4-week washout A total of 52 patients will be randomized over a two-year period The primary outcome measure will be the change in Epworth sleepiness scale between patients receiving caffeine versus placebo Secondary outcome measures will include other sleep scales tolerability measures and measures of motor function and overall quality of life After tests to assess normal distribution analysis will be with two-sample t-test
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