Advanced Parkinson's Disease MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Neupro 4mg/24h transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ROTIGOTINE
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
UCB Celltech, UK - Registered Branch of UCB Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent form (ICF) is signed and dated by the subject. 2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication application according to the judgment of the investigator. 3. Subject is male or female, =18 years of age. 4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of rotigotine (or longer, if required by local regulations). 5. Subject has advanced Parkinson’s disease (ie, takes levodopa [L-DOPA]) and has been on a stable dose of L-DOPA (in combination with either benserazide or carbidopa) for at least 28 days prior to the Baseline Visit. 6. Subject has a Hoehn and Yahr stage score of 2 to 4. 7. Subject has sleep-maintenance insomnia (PDSS2 item 3=“often” or 4=“very often”). 8. If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase (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 study. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study. 2. Subject has participated in another study of an IMP or a medical device within the previous 30 days, or is currently participating in another study of an IMP or a medical device. 3. Subject has a history of chronic alcohol or drug abuse within the previous year. 4. Subject has any medical or psychiatric condition (eg, severe hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject’s well being or ability to participate in this study. 5. Subject has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol. 6. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications. 7. Subject received therapy with controlled-release L-DOPA, entacapone, or Stalevo® within 28 days prior to the Baseline Visit or has ever received therapy with tolcapone. 8. Subject discontinued from previous therapy with a DA after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator. 9. Subject has had prior therapy with a DA within 28 days prior to the Baseline Visit. 10. Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), MAO-A inhibitors, methylphenidate, or amphetamine. 11. Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication [eg, modafinil]), unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study. 12. Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes). 13. Subject has a history of seizures or stroke within 1 year or a history of myocardial infarction within 6 months prior to enrollment (ie, the date of signing the ICF). 14. Subject has evidence of an impulse control disorder (ICD) according to a positive modified Minnesota Impulsive Disorders Interview (mMIDI), and a diagnosis of ICD confirmed by a structured interview at Screening (Visit 1). If the subject refuses the structured interview after a positive module on the mMIDI, the subject is excluded from study participation. 15. Subject has evidence of significant cognitive impairment with a Mini Mental State Examination (MMSE) score of less than 25 at Screening (Visit 1). 16. Subject’s condition has previously been diagnosed as narcolepsy, sleep apnoea syndrome, significant REM Sleep Behavior disorder (RBD), moderate to severe RLS as assessed by the International Restless Legs Scale (IRLS), or periodic limb movement disorder. 17. Subject is pregnant or lactating. 18. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (‘yes’) to either Question 4 or Question 5 of the C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of rotigotine in improving sleep efficiency measured by PSG in subjects with advanced Parkinson’s disease as compared to placebo.;Secondary Objective: The secondary objectives are to assess the effects of rotigotine on sleep maintenance, insomnia, nocturnal akinesia, and night-time movement in bed, as determined by objective and subjective measures in subjects with advanced Parkinson’s disease as compared to placebo.;Primary end point(s): Change in the SEI (%) (Sleep Efficiency Index) ;Timepoint(s) of evaluation of this end point: From baseline to the end of 4 weeks maintenance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in the score of the PDSS2 (Parkinson’s Disease Sleep Scale (version 2) 2. Change in the score of the ESS (Epworth Sleepiness Scale) 3. Change in the sleep period time in stage 3 nonREM (nonrapid eye movement) (%) sleep (slow wave sleep time) 4. Change in the NADCS (Nocturnal Akinesia, Dystonia, and Cramps Score) 5. Change in the total WASO (wakefulness after sleep onset) 6. Change in the total number of turnings in bed ;Timepoint(s) of evaluation of this end point: - From Baseline by Day 1 of the Maintenance Period and Week 4 of the Maintenance Period (for endpoints 1., 2., 4.) - From Baseline to Week 4 of the Maintenance Period (for endpoints 3., 5., 6.) | — |
Countries
United Kingdom
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed