Varenicline, a partial nicotinic receptor agonist, for the treatment of excessive daytime sleepiness in Parkinson*s disease: a placebo-controlled cross-over study

Phase 3

Completed

Conditions: idiopathic Parkinson's disease
Parkinson's disease
10028037

Registration Number: NL-OMON43609

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

-idiopathic Parkinson's Disease (PD) according to criteria UK PD Society Brain Bank
-receiving stable PD medications for at least 4 weeks before and throughout the study
-excessive daytime sleepiness (defined by a score of >10 on the Epworth Sleeping Scale)

Exclusion Criteria

- patients receiving medications with known central depressant effects
- dementia
- depression
- known sleep apnea or narcolepsy
- current smoking
- contra-indications for treatment with varenicline (psychiatric illness, renal failure, ischemic cardial disease, stroke, insuline-dependent diabetes)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical outcome measure is the difference on Epworth Sleepiness<br /><br>Scale (ESS) between the two treatments (varenicline versus<br /><br>placebo).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are the differences on the SCOPA-sleep,<br /><br>Pittsburgh Sleep Quality Index, the Abnormal Involuntary Movements Scale, the<br /><br>Fatigue Severity Scale and the Medical Outcome Survey Short Form (SF-36) for<br /><br>quality of life. A neurophysiological outcome measure is the mean time before<br /><br>falling asleep in the Maintenance of Wakefulness Test (MWT). In a randomized<br /><br>subgroup the differences in pharmacodynamic effects on central nervous system<br /><br>functioning of varenicline after first administration and in steady state<br /><br>condition through scores on the NeuroCart test battery are investigated.</p><br>