Parkinson's disease MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Co
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject is male or female, =18 years of age. 4. Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV, see Section 15.9) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes. 5. Subject has unsatisfactory early morning motor impairment as determined by the investigator. 6. If subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit. 7. 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. 8. Subject must understand the investigational nature of the trial and be willing and able to comply with the trial requirements. 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: 1. Subject has previously participated in a trial with rotigotine or has experienced treatment failure with commercially available rotigotine (Neupro®). 2. 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. 3. 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. 4. Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline (Visit 2). 5. Subject has had therapy with controlled-release L-DOPA within 28 days prior to Baseline (Visit 2) or is receiving therapy with tolcapone. 6. Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine. 7. Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline. 8. Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes). 9. Subject has a history of atopic eczema and/or active skin disease, such as atopic eczema. 10. Presence of dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication). 11. Subject is receiving central nervous system (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 (Visit 2) and is likely to remain stable for the duration of the trial. 12. 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. 13. Subject has neoplastic disease requiring therapy within 12 months prior to enrollment. 14. Presence of clinically relevant hepatic dysfunction. 15. Presence of clinically relevant renal dysfunction. 16. Evidence of clinically relevant cardiovascular disorders. 17. Subject has a QT interval corrected for heart rate Bazett (QTcB) of =500msec at Screening or Baseline (Visit 1 or 2, see Section 7.3.3). 18. Subject has a history of chronic alcohol or drug abuse within the last 6 months. 19. Subject has clinically significant laboratory results that, in the opinion of the investigator, would make the subject unsuitable for entry into the trial. 20. 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 a highly effective method of birth control and at least 1 barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least 2 years post menopausal. 21. 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. 22. Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Int
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinson’s disease.;Secondary Objective: In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson’s disease will be evaluated.;Primary end point(s): • Change from Baseline to the end of Maintenance in early morning UPDRS Part III score (early morning, prior to any medication intake) • Change from Baseline to end of Maintenance in Parkinson’s Disease Sleep Scale (PDSS) | — |
Countries
Austria, Finland, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed