Idiopathic Parkinson's Disease Clinical Trial
Official title:
Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists
The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine
agonist piribedil on vigilance and cognitive performances in patients with Parkinson's
disease in comparison with other oral non-ergot dopamine agonists.
It should be tested whether piribedil is superior to continued pramipexole or ropinirole
treatment regarding improvement of reduced vigilance and cognitive performance in patients
with Parkinson's disease.
Treatment of motor symptoms associated with PD by non-ergot dopamine agonists has been
proven to be effective, both as monotherapy and in combination with levodopa. Non-motor
symptoms like cognitive or sleep-related disorders and disturbed vigilance, however, are
common in PD and can significantly worsen health and quality of life of the patient and
family members. Some of these non-motor symptoms may also be caused by the antiparkinsonian
medication per se. The Committee for Proprietary Medicinal Products (CPMP) initiated a
review of dopamine agonists in relation to episodes of sudden onset of sleep already in 2000
which resulted in special warnings of somnolence and sudden sleep attacks in the non-ergot
dopamine agonists' summary of product characteristics.
Beneficial effects of piribedil on parameters of vigilance and cognition have been described
in several studies. But, as it seems, no study has been performed so far to identify such
effects in the setting of a comparative study with different oral non-ergot dopamine
agonists in patients with PD, and utilizing vigilance and cognitive parameters as primary
and main secondary objective. The neuropsychological tests being applied in this study are
validated and routinely used tests in studies investigating different aspects of attention
or vigilance and cognition.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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