Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists (PIVICOG-PD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01007864|
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : May 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Drug: piribedil Drug: pramipexole or ropinirole||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
Other Name: Clarium®
|Active Comparator: pramipexole or ropinirole||
Drug: pramipexole or ropinirole
continuation of pre-study treatment regimen
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007864
|Ulm, Baden-Württemberg, Germany, 89081|
|Wolfach, Baden-Württemberg, Germany, 77709|
|München, Bayern, Germany, 80804|
|Berlin-Steglitz, Berlin, Germany, 12163|
|Marburg, Hessen, Germany, 35043|
|Göttingen, Niedersachsen, Germany, 37075|
|Dresden, Sachsen, Germany, 01307|
|Leipzig, Sachsen, Germany, 04107|
|Gera, Thüringen, Germany, 07551|
|Stadtroda, Thüringen, Germany, 07646|
|Berlin, Germany, 12200|
|Berlin, Germany, 13353|
|Study Director:||Martina Wangemann, Dr.||Desitin Arzneimittel GmbH|