Parkinson's Disease
Conditions
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent. - Subject is willing and able to comply with all trial requirements. - Subject is male or female, =18 years of age and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject has previously participated in a trial with rotigotine. - Subject has participated in another trial of an investigational drug within the last 28 days or is currently participating in another trial of an investigational drug. - Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment at an adequate dose due to lack of efficacy as assessed by the investigator. - Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline. - Subject is receiving therapy with controlled-release levodopa within 28 days prior to baseline or is receiving therapy with tolcapone. - Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Visit 2: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (including atypical), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine. - Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to baseline. - Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes). - Subject has a history of atopic eczema and/or active skin disease, such as atopic eczema. - Presence of dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication). - Subject is receiving CNS therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to baseline and is likely to remain stable for the duration of the trial. - Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment. - Subject has neoplastic disease requiring therapy within 12 months prior to enrollment. - Presence of clinically relevant hepatic dysfunction. - Presence of clinically relevant renal dysfunction. - Evidence of clinically relevant cardiovascular disorders. - Subject has a QTcB interval of =500msec at Screening or Baseline (Visit 1 or 2; repeated measurements within 1 hour). - Subject has a history of chronic alcohol or drug abuse within the last 6 months. - Subject has clinically significant laboratory results that, in the opinion of the investigator, would make the subject unsuitable for entry into the trial. - Subject is pregnant or nursing, or is of child bearing potential but (i) not surgically sterile, or, (ii) not using adequate birth control methods (including at least one barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least two years post menopausal. - Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this trial. - Subject has a known hypersensitivity to any components of the trial medication stated in this protocol. - Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye movement (REM) behavior disorder, restless legs syndrome, or periodic limb movement disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of rotigotine on the control of early morning motor impairment and sleep disorders in subjects with idiopathic Parkinson's disease.;Secondary Objective: ;Primary end point(s): Motor performance: •Decrease in early morning motor impairment from Baseline to the end of Maintenance as measured in the morning before patch application using the UPDRS Part III (Motor Examination) score •Change from Baseline to end of Maintenance in tapping rate as measured in the morning before patch application •Change from Baseline to end of Maintenance in standing-walking-turning test before the morning patch application •Improvement in nocturnal akinesia as measured by change from Baseline to end of Maintenance in Nocturnal Akinesia Score Sleep disorders: •Change from Baseline to end of Maintenance in Parkinson's Disease Sleep Scale (PDSS) •Change from Baseline to end of Maintenance in Epworth Sleepiness Scale (ESS) •Change from Baseline to end of Maintenance in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) •Change from Baseline to end of Maintenance in number of nocturias | — |
Countries
Austria, United Kingdom
Outcome results
None listed