Clinical trial NCT01300819: Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Official title: Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro®
Non-motor symptoms
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

* Subject is male or female, ≥18 years of age
* Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
* Subject has a Hoehn and Yahr stage score ≤4
* Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
* If the 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
* If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or 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

Exclusion Criteria:

* 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 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), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
* Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors \[SSRIs\], anxiolytics, or other sleep-modifying medication) 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
* Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview

Primary outcomes:
measure: Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Secondary outcomes:
measure: Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
measure: Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous
timeFrame: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: 101
city: Wien
country: Austria
facility: 104
city: Wien
country: Austria
facility: 107
city: Antwerpen
country: Belgium
facility: 125
city: Brugge
country: Belgium
facility: 121
city: Brussels
country: Belgium
facility: 122
city: Gent
country: Belgium
facility: 124
city: Liege
country: Belgium
facility: 131
city: Plovdiv
country: Bulgaria
facility: 44
city: Russe
country: Bulgaria
facility: 52
city: Sofia
country: Bulgaria
facility: 41
city: Sofia
country: Bulgaria
facility: 45
city: Sofia
country: Bulgaria
facility: 48
city: Sofia
country: Bulgaria
facility: 49
city: Sofia
country: Bulgaria
facility: 53
city: Varna
country: Bulgaria
facility: 42
city: Chomutov
country: Czech Republic
facility: 232
city: Litomysl
country: Czech Republic
facility: 227
city: Ostrava-Poruba
country: Czech Republic
facility: 222
city: Plzen
country: Czech Republic
facility: 231
city: Praha
country: Czech Republic
facility: 233
city: Aix-en Provence
country: France
facility: 189
city: Amiens
country: France
facility: 181
city: Limoges
country: France
facility: 186
city: Pessac
country: France
facility: 185
city: Roanne
country: France
facility: 184
city: Toulouse
country: France
facility: 183
city: Berlin
country: Germany
facility: 62
city: Berlin
country: Germany
facility: 77
city: Bochum
country: Germany
facility: 67
city: Böblingen
country: Germany
facility: 80
city: Marburg
country: Germany
facility: 61
city: Oldenburg
country: Germany
facility: 79
city: Stuttgart
country: Germany
facility: 114
city: Ulm
country: Germany
facility: 65
city: Westerstede
country: Germany
facility: 73
city: Budapest
country: Hungary
facility: 87
city: Budapest
country: Hungary
facility: 88
city: Gyor
country: Hungary
facility: 95
city: Miskolc
country: Hungary
facility: 89
city: Nyiregyhaza
country: Hungary
facility: 81
city: Pecs
country: Hungary
facility: 84
city: Szeged
country: Hungary
facility: 86
city: Arcugnano
country: Italy
facility: 254
city: Chieti Scalo
country: Italy
facility: 267
city: Napoli
country: Italy
facility: 270
city: Perugia
country: Italy
facility: 266
city: Pisa
country: Italy
facility: 264
city: Pozzilli
country: Italy
facility: 257
city: Roma
country: Italy
facility: 262
city: Treviso
country: Italy
facility: 269
city: Varese
country: Italy
facility: 258
city: Venezia
country: Italy
facility: 252
city: Verona
country: Italy
facility: 255
city: Brasov
country: Romania
facility: 207
city: Bucuresti
country: Romania
facility: 201
city: Bucuresti
country: Romania
facility: 213
city: Clluj-Napoca
country: Romania
facility: 203
city: Cluj-Napoca
country: Romania
facility: 211
city: Sibiu
country: Romania
facility: 208
city: Sibiu
country: Romania
facility: 217
city: Targu Mures
country: Romania
facility: 212
city: Timisoara
country: Romania
facility: 204
city: Timisoara
country: Romania
facility: 209
city: Banska Bystrica
country: Slovakia
facility: 245
city: Banska Bystrica
country: Slovakia
facility: 247
city: Bratislava
country: Slovakia
facility: 240
city: Bratislava
country: Slovakia
facility: 242
city: Bratislava
country: Slovakia
facility: 243
city: Dolni Kubin
country: Slovakia
facility: 249
city: Krompachy
country: Slovakia
facility: 250
city: Lucenec
country: Slovakia
facility: 244
city: Zilina
country: Slovakia
facility: 248
city: Alicante
country: Spain
facility: 157
city: Barcelona
country: Spain
facility: 142
city: Barcelona
country: Spain
facility: 146
city: Madrid
country: Spain
facility: 143
city: Madrid
country: Spain
facility: 145
city: Madrid
country: Spain
facility: 147
city: Madrid
country: Spain
facility: 148
city: Oviedo
country: Spain
facility: 158
city: Sant Cugat (Barcelona)
country: Spain
facility: 141
city: Santiago de Compostela
country: Spain
facility: 152
city: Lugano
country: Switzerland
facility: 24
city: Sargans
country: Switzerland
facility: 26
city: St. Gallen
country: Switzerland
facility: 21
city: Zuerich
country: Switzerland
facility: 22
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.