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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43609

Enrollment

Registered

2012-07-25

Start date

2013-05-10

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic Parkinson's disease Parkinson's disease

Interventions

Patients will be randomly assigned to start an active treatment or placebo and complete two periods of four weeks with a washout period of two weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
The primary clinical outcome measure is the difference on Epworth Sleepiness Scale (ESS) between the two treatments (varenicline versus placebo).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)