NCT00459420

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2007

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

4.3 years

First QC Date

April 11, 2007

Last Update Submit

April 15, 2015

Conditions

Parkinson's DiseaseExcessive Daytime Somnolence

Keywords

Parkinson's diseaseExcessive Daytime SomnolenceCaffeineDisease-Modifying

Outcome Measures

Primary Outcomes (1)

  • Change in Epworth Sleepiness Scale

    3 weeks

Secondary Outcomes (9)

  • Unified Parkinson Disease Rating Scale

    3 weeks

  • Clinical Global Impression of Change

    3 weeks

  • Pittsburgh Sleep Quality Index

    3 weeks

  • Fatigue Severity Scale

    3 weeks

  • Stanford Sleep Scale

    3 weeks

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: placebo

Caffeine

EXPERIMENTAL
Drug: Caffeine 100-200 mg BID

Interventions

Caffeine 100-200 mg BIDDRUG

Caffeine 100 mg BID for three weeks, then 200 mg BID for three weeks, then 100 mg BID for 1 week, then placebo

Caffeine
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of idiopathic PD
  • Excessive daytime somnolence (defined as an Epworth sleepiness scale score of \>10).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Parkinson DiseaseDisorders of Excessive Somnolence

Interventions

CaffeineBID protein, human

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ron Postuma, MD, MSc

    Montreal General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

April 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

CA(2)