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Caffeine for Excessive Daytime Somnolence in Parkinson's Disease

NCT00459420 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-04-16

No results posted yet for this study

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

Conditions

Interventions

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

DRUG

placebo

placebo

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Toronto

    collaborator OTHER

  • Ron Postuma

    lead OTHER

Principal Investigators

  • Ron Postuma, MD, MSc · Montreal General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459420 on ClinicalTrials.gov