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Sponsors and Collaborators: |
McGill University Health Center University of Toronto |
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Information provided by: | McGill University Health Center |
ClinicalTrials.gov Identifier: | NCT00459420 |
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
Condition | Intervention | Phase |
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Parkinson's Disease Excessive Daytime Somnolence |
Drug: Caffeine 100-200 mg BID Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease |
Estimated Enrollment: | 52 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: placebo
placebo
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Caffeine: Experimental |
Drug: Caffeine 100-200 mg BID
Caffeine 100 mg BID for three weeks, then 200 mg BID for three weeks, then 100 mg BID for 1 week, then placebo
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Parkinson's 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Wadup, RN | 514 934-1934 ext 42522 | lisa.wadup@muhc.mcgill.ca |
Contact: Ron Postuma, MD, MSc | 514 934-8058 | ronpostuma@hotmail.com |
Canada, Ontario | |
Toronto Western Hospital | Not yet recruiting |
Toronto, Ontario, Canada | |
Contact: Francis Baraqui, RN 416.603.5800 ext 2664 fbaraqui@uhnres.utoronto.ca | |
Canada, Quebec | |
Montreal General Hospital | Recruiting |
Montreal, Quebec, Canada, H3G 1A4 | |
Contact: Ron Postuma, MD 514 934-8058 ronpostuma@hotmail.com | |
Contact: Anne-Louise Lafontaine, MD 514 934-8026 anne-louise.lafontaine@muhc.mcgill.ca | |
Principal Investigator: Ron Postuma, MD, MSc | |
Sub-Investigator: Anne-Louise Lafontaine, MD, MSc |
Principal Investigator: | Ron Postuma, MD, MSc | Montreal General Hospital |
Responsible Party: | MUHC ( Ron Postuma ) |
Study ID Numbers: | GEN-06-68 |
Study First Received: | April 11, 2007 |
Last Updated: | February 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00459420 History of Changes |
Health Authority: | Canada: Health Canada |
Parkinson's disease Excessive Daytime Somnolence Caffeine Disease-Modifying |
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Neurodegenerative Diseases Phosphodiesterase Inhibitors Parkinson Disease Movement Disorders Caffeine Parkinsonian Disorders |
Caffeine citrate Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Central Nervous System Stimulants Enzyme Inhibitors Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Phosphodiesterase Inhibitors Parkinson Disease Movement Disorders Therapeutic Uses Caffeine Parkinsonian Disorders Central Nervous System Agents |