idiopathic Parkinson's disease MedDRA version: 12.0 Level: PT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Clarium 50 mg Retardtabletten
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: piribedil
CAS Number: 3605-01-4
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Desitin Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - to evaluate the effects of piribedil on cognitive functions; - to evaluate the safety of piribedil; - to evaluate the tolerability of piribedil. ;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) | — |
Countries
Germany
Outcome results
None listed