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 - PIVICOG-PD

• Conditions: idiopathic Parkinson's disease; MedDRA version: 12.0Level: PTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2009-012419-16-DE
• Lead Sponsor: Desitin Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-20
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male or female Caucasian patients aged 35 to 80 years;
- Patients with idiopathic Parkinson's disease;
- Hoehn & Yahr stages 1 to 4;
- Stable medication with anti-parkinsonian medication, including stable treatment with pramipexole or ropinirole, for at least 4 weeks prior to Screening;
- Significant daytime sleepiness: Epworth Sleepiness Scale score ?equals or is greater than 11 under previous therapy with pramipexole or ropinirole;
- Patients who have read and understood the patient information sheet and have provided a signed written informed consent form;
- Patients are considered to be compliant to the study regimen.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Treatment of Parkinson’s disease with any dopamine agonist other than pramipexole or ropinirole within 4 weeks prior to Screening;
- Known hypersensitivity to Clarium or its excipients;
- Patients with daytime sleepiness caused by other factor’s than Parkinson’s disease, i.e., idiopathic narcolepsy, shift work, severe alcohol abuse, obstructive diseases, sleep apnea syndrome, or Periodic limb movement disorder;
- Secondary and atypical Parkinson syndrome;
- Depression (Beck Depression Inventory ?score greater than 16);
- Dementia (Mini-Mental State Examination score equal to or smaller than 24);
- Severe disability in extremities which could influence clinical assessments;
- Clinically significant disease concerning the lung, liver or kidney;
- Any acute or chronic infection that may influence the outcome of the study;
- Cardiovascular shock;
- Acute myocardial infarction;
- Congestive heart failure NYHA class III or IV;
- Uncontrolled arterial hypertension (diastolic blood pressure equal to or greater than 105 mmHg) or clinically relevant hypotension;
- Evidence of clinically active cancer;
- Color vision defect that may have impact on assessment of FWIT;
- History of substance abuse;
- Intake of benzodiazepines (or derivates) if not at stable dose for at least 4 weeks prior to Screening; antiallergic agents (H1 receptor antagonists, except selective, non-sedating H1-antihistamines, e.g. loratadine and others), substances with psychostimulant properties (e.g., amphetamine, modafinil), or antidepressants if not at stable dose for at least 2 months prior to Screening;
- Current treatment with neuroleptic agents (except for clozapine);
- Female patients who are pregnant or lactating;
- Female patients of childbearing potential who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner;
- Mental condition rendering the patient unable to understand the nature, scope and possible risks of the study;
- Patient has a history of or is suspicious of unreliability, poor co-operation or non-compliance with medical treatment;
- Patients are currently or previously (within the last 28 days) participating in another study of an investigational drug;
- Patients who were previously enrolled in this study;
- Patients with known Hepatitis B or C or HIV infection;
- Patients who are employees of the sponsor or patients who are employees or relatives of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to test whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance in patients with Parkinson’s disease. ;Secondary Objective: The secondary objectives of this study are:<br>- to evaluate the effects of piribedil on cognitive functions;<br>- to evaluate the safety of piribedil;<br>- to evaluate the tolerability of piribedil.<br>;Primary end point(s): Parameter ‘median reaction time during second 15 minutes (minutes 16-30)’ of the subtest ‘vigilance’, visual test condition ‘moving bar’ of the Test battery for Attention Performance (TAP)