Caffeine for Excessive Daytime Somnolence in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT00459420
• Date of registration: 11/04/2007
• Prospective Registration: No
• Primary sponsor: Ron Postuma
• Public title: Caffeine for Excessive Daytime Somnolence in Parkinson's Disease
• Scientific title: Caffeine for Excessive Daytime Somnolence in Parkinson's Disease
• Date of first enrolment: April 2007
• Target sample size: 58
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00459420
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Ron Postuma, MD, MSc
• Affiliation: Montreal General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Excessive Daytime Somnolence

Intervention(s)

Drug: placebo

Drug: Caffeine 100-200 mg BID

Primary Outcome(s)

Change in Epworth Sleepiness Scale [Time Frame: 3 weeks]

Secondary Outcome(s)

Pittsburgh Sleep Quality Index [Time Frame: 3 weeks]

Beck Depression Inventory [Time Frame: 3 weeks]

Tolerability of Caffeine [Time Frame: 3 weeks]

PDQ-39 [Time Frame: 3 weeks]

Clinical Global Impression of Change [Time Frame: 3 weeks]

Fatigue Severity Scale [Time Frame: 3 weeks]

SF-36 [Time Frame: 3 weeks]

Stanford Sleep Scale [Time Frame: 3 weeks]

Unified Parkinson Disease Rating Scale [Time Frame: 3 weeks]

Secondary ID(s)

GEN-06-68

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Toronto

Canadian Institutes of Health Research (CIHR)