Parkinson's Disease
Conditions
Interventions
Product Name: Rotigotine
Product Code: SPM962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equa
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. - Subject has idiopathic early-stage Parkinson's disease (Hoehn & Yahr Stage I-III; see Section 15.9) =5 years in duration, with at least two (2) or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, postural instability; and without any other known or suspected cause of Parkinsonism. - Subject has a UPDRS motor score (part III) of =10 at baseline (Visit 2) - Subject has unsatisfactory control of early morning motor impairment as determined by the investigator. - If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), or an n-methyl-d-aspartate (NMDA) antagonist (eg, amantadine), he/she must have been on a stable dose for at least 28 days prior to the Baseline visit and must be maintained on that dose for the duration of the trial. Are the trial subjects under 18? 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: - 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 levodopa within 28 days prior to baseline or is receiving therapy with entacapone or tolcapone; subject has received levodopa for more than 6 months since diagnosis. - Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Visit 2: dopamine agonists, alpha-methyl dopa, metoclopramide, reserpine, budipine, neuroleptics (including atypical), MAO-A inhibitors, methylphenidate, amphetamine, or central dopamine antagonists. - 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. - Subject has 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 12 months prior to enrollment, or has had a TIA within 12 months prior to enrollment, or has a history of myocardial infarction within the last 6 months prior to enrollment. - Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment. - Subject has clinically relevant hepatic dysfunction. - Subject has clinically relevant renal dysfunction. - Subject has 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 relevant 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 childbearing 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 2 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 history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to ropinirole. - 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: The objective of this trial is to compare the effect of rotigotine and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD.;Secondary Objective: ;Primary end point(s): Motor performance: • Change from Baseline to end of Maintenance in early morning motor impairment as measured in the morning before patch application/morning dose of trial medication 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/morning dose of trial medication • Change from Baseline to end of Maintenance in standing-walking-turning test before patch application/morning dose of trial medication • Change from Baseline to end of Maintenance in nocturnal akinesia as measured by change in Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) by using item Nocturnal Akinesia 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 NADCS by using items Dystonia and Cramps • Change from Baseline to end of Maintenance in number of nocturias. Other efficacy assessments: • Severity of illness and global improvement as assessed by Clinical Global Impression (CGI) • Severity of illness and global improvement as assessed by Patient Global Impression (PGI) • Change from Baseline to end of Maintenance in short-form Parkinson's disease Questionnaire (PDQ-8) • Change from Baseline to end of Maintenance in UPDRS Part I (Mentation, Behavior and Mood) score • Change from Baseline to end of Maintenance in UPDRS Part II (Activities of Daily Living) score • Change from Baseline to end of Maintenance in UPDRS Part IV (Complications of Therapy) score • Rating of patch application site preference and satisfaction with tria | — |
Countries
Germany, Italy
Outcome results
None listed