Idiopathic Parkinson's disease
Conditions
Interventions
Product Name: rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotine
CAS Number: 99755-59-6
Current Sponsor code: SPM 962
Concentration unit: mg/m2 mil
Sponsors
SCHWARZ BIOSCIENCES
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, aged greater than or equal to 18 years 4. Subjects with idiopathic Parkinson's disease (Hoehn and Yahr stage I-IV), as defined by cardinal sign, bradykinesia and at least one of the following: resting tremor, rigidity or impairment of postural reflexes 5. Subject is not satisfactorily controlled on a total daily dose of ropinirole up to 9.0mg, pramipexole up to 2.0mg or cabergoline up to 3.0mg 6. If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benzserazide or carbidopa), the total daily dose must be stable for 28 days prior to the baseline visit and must remain stable for the duration of the trial 7. If the subject is receiving an anticholinergic agent (e.g. benztropine, trihexypheniyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (e.g. selegiline), or an N-methyl-d-aspartate (NMDA) antagonist (e.g. 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? 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 2. Subject has previously participated in another trial of an investigational drug 3. Subject has atypical Parkinson's syndrome(s), including drug-induced Parkinsonian syndrome 4. Subject has dementia, active psychosis or hallucinations (not due to antiparkinsonian medication) 5. Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (including atypical), MAO-A inhibitors, methylphenidate or amphetamine 6. Subject is currently receiving CNS active therapy (e.g. sedatives, hypnotics, anti-depressants, antiolytics) 7. Subject has a history of seizures or stroke within 1 year, has had a TIA within 12 months prior to enrolment, or a history of myocardial infarction within the last 6 months prior to enrolment 8. Presence of clinically relevant hepatic dysfunction 9. Presence of clinically relevant renal dysfunction 10. Evidence of clinically relevant cardiovascular disorders 11. Subject has QTcB interval of greater than or equal to 500msec at pretreatment or baseline (repeated measurements within 1 hour) 12. Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to baseline 13. Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis 14. Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrolment 15. Subject has a history of chronic alcohol or drug abuse within the last 6 months 16. Subject has clinically significant laboratory results that, in the judgement of the investigator, would make the subject unsuitable for entry into the trial 17. 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) not at least 2 years postmenopausal 18. Subject has any other clinically significant medical or psychiatric condition that would, in the opinion of the investigator, interfere with the subject's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of switching subjects from ropinirole, pramipexole or cabergoline to the rotigotine transdermal system and its effects on symptoms in subjects with idiopathic Parkinson's disease;Secondary Objective: not applicable;Primary end point(s): TOLERABILITY - The total number of subjects completing the trial from baseline to the end of treatment - The total number of subjects completing the trial on their original treatment assignment from baseline to the end of treatment - The total number of subjects completing the trial with at least one dose adjustment from baseline to the end of treatment EFFECT ON SYMPTOMS AND OTHER VARIABLES - Severity of illness and global improvement as assessed by change from baseline to end of treatment in Clinical Global Impression (CGI) - Severity of illness and global improvement as assessed by change from baseline to end of treatment in Patient Global Impression (PGI) - Change from baseline to end of treatment in UPDRS Part I (Mentation, Behaviour and Mood) score - Change from baseline to end of treatment in UPDRS Part II (Activities of Daily Living) score - Change from baseline to end of treatment in UPDRS Part III (Motor Examination) score - Change from baseline to end of treatment in UPDRS Part IV (Complications of Therapy) score - Change from baseline to end of treatment in short-form Parkinson's disease questionnaire (PDQ-8) - Change from baseline to end of treatment in Parkinson's disease sleep scale (PDSS) - Change from baseline to end of treatment in Epworth sleepiness scale (ESS) Rating of patch application site preference and satisfaction with trial treatment as assessed by a patient preference questionnaire SAFETY - Frequency and severity of adverse events (AEs), as reported spontaneously by the subject or observed by the Investigator, recorded over the course of the trial - Changes in vital signs, electrocardiograms (ECGs) and clinical laboratory values over the course of the trial - Ad | — |
Countries
United Kingdom
Outcome results
None listed