Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Desitin Arzneimittel GmbH
• Collaborator: FGK Clinical Research GmbH
• Treatments: Dopamine; Dopamine Agents; Dopamine Agonists; Loratadine; Piribedil; Pramipexole; Ropinirole

Criteria

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 higher 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.

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 higher than 16);

• Dementia (Mini-Mental State Examination score equals or is lower 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 equals or is higher 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; intake of 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.