Caffeine as a Therapy for Parkinson's Disease

NCT01738178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2017-03-22

No results posted yet for this study

Summary

Parkinson's disease is a common neurodegenerative disorder in which patients experience progressive motor disability and many disabling non-motor symptoms. Recent studies have consistently found that people who do not use caffeine are at higher risk of developing Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.

In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the motor manifestations of disease. There have been other lines of evidence that have suggested caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID vs matching placebo for motor and non-motor aspects of disease. This will be in three stages. In the first six-month stage, medications will be held constant, to see whether caffeine does have motor benefits. Then we will perform a four-year extension stage to define if the effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of other PD meds and/or prevents their side effects. Finally, we will finish with a six-month stage in which we will place all patients on caffeine - this will allow us to assess caffeine's use in later disease, but more importantly, will assess whether early use of caffeine produces long term changes beyond its immediate effects.

Conditions

Interventions

DRUG

Caffeine

DRUG

Placebo

Sponsors & Collaborators

  • Pontifícia Universidade Católica do Paraná

    collaborator OTHER
  • University of Calgary

    collaborator OTHER
  • University of Newfoundland and Eastern Health

    collaborator UNKNOWN
  • University Health Network, Toronto

    collaborator OTHER
  • UBC Hospital

    collaborator UNKNOWN
  • Movement Disorder Clinic - Deer Lodge Centre

    collaborator UNKNOWN
  • The Ottawa Hospital

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Ronald B Postuma, MD, MSc · Research Insitute of the MUHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-05-01
Completion
2016-12-01

Countries

  • Brazil
  • Canada

Study Locations

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Entities

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 NCT01738178 on ClinicalTrials.gov