Clinical trial NCT01007864 (phase 3, status: completed)
Conditions: idiopathic parkinson's disease
ICD codes: G20
Drugs: piribedil, pramipexole or ropinirole
SMILES: C(N1CCN(CC1)C1=NC=CC=N1)C1=CC2=C(OCO2)C=C1, CCCN[C@H]1CCC2=C(C1)SC(N)=N2
Eligibility 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.