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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.
continuation of pre-study treatment regimen
Unnamed facility
Ulm, Baden-Wurttemberg, Germany
Unnamed facility
Wolfach, Baden-Wurttemberg, Germany
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Marburg, Hesse, Germany
Unnamed facility
Göttingen, Lower Saxony, Germany
Unnamed facility
Dresden, Saxony, Germany
Unnamed facility
Leipzig, Saxony, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Steglitz, State of Berlin, Germany
...and 2 more locations
The primary efficacy variable will be the 'median reaction time during the second 15 minutes (minutes 16-30)' of the subtest 'vigilance', visual test condition 'moving bar', of the Test battery for Attention Performances (TAP) at end of treatment.
Time frame: Baseline and End of Treatment
Other vigilance parameters of the TAP test
Time frame: Baseline and End of Treatment
Other neuropsychological tests: Test of verbal fluency (RWT), Verbal learning memory test (VLMT), Stroop test (FWIT)
Time frame: Baseline and End of Treatment
Epworth Sleepiness Scale (ESS)
Time frame: Baseline and End of Treatment
Parkinson's Disease Sleeping Scale (PDSS)
Time frame: Baseline and End of Treatment
Unified Parkinson's Disease Rating Scale (UPDRS) subscores I to IV and total score
Time frame: Baseline and End of Treatment
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: Baseline and End of Treatment
Clinical Global Impressions (CGI) (except item 3.2)
Time frame: End of Treatment
Patient Global Impression (PGI)
Time frame: End of Treatment
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