Caffeine for Excessive Daytime Somnolence in Parkinson's Disease
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Many patients with Parkinson's 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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Ron Postuma
Collaborators:
Canadian Institutes of Health Research (CIHR) University of Toronto