Caffeine for Excessive Daytime Somnolence in Parkinson's Disease

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ron Postuma
• Collaborators: Canadian Institutes of Health Research (CIHR); University of Toronto
• Treatments: Caffeine

Criteria

Inclusion Criteria:

• A diagnosis of idiopathic PD

• Excessive daytime somnolence (defined as an Epworth sleepiness scale score of >10).

Exclusion Criteria:

• Estimated daily caffeine intake of more than 200 mg per day

• Active peptic ulcer disease

• Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter)

• Uncontrolled hypertension - defined as systolic bp >170 or diastolic bp >110 on two consecutive readings

• EDS is caused by sleep apnea, restless legs syndrome, narcolepsy, shift work, or sleep promoting agents.

• Current use of prescribed alerting agents such as modafinil and methylphenidate

• Pre-menopausal women who are not using effective methods of birth control

• Dementia, defined as MMSE <24/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process

• Depression, as defined by a Beck Depression Inventory score of >15.

• Changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the study protocol.