idiopathic Parkinson's disease MedDRA version: 12.0 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Neupro 2 mg/24 h transdermal patch
Product Name: Rotigotine transdermal patch 2mg/24h(10cm2)
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
C
Sponsors
Schwarz Pharma Deutschland GmbH, UCB Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the subject or legal representative. 2. Subject is considered reliable and capable of adhering to the protocol, visit schedule and medication intake. 3. Subject is male or female, at least 18 years of age. 4. The subject must have a diagnosis of idiopathic Parkinson's disease. 5. Subject suffers from gastrointestinal complaints of any reason at Baseline (as per protocol). 6. Subject receives an oral dopamine agonist at Baseline 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 was previously treated with the rotigotine transdermal patch. 2. Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the last 30 days or is currently participating in another study of an IMP (or a medical device). 3. Subject has a history of chronic alcohol abuse or of drug abuse within the last 30 days. 4. Subject has any medical or psychiatric condition that could jeopardize or would compromise the subject’s ability to participate in this study. 5. Subject has a known hypersensitivity to any components of the IMP. 6. Subject has had prior therapy with carbidopa/levodopa within 28 days of Baseline or subject has received carbidopa/levodopa for more than six months since diagnosis. 7. Subject has taken domperidone during the week before Baseline. 8. Subject suffers from vascular or drug-induced Parkinson’s disease. 9. 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 postmenopausal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the therapeutic value of the rotigotine transdermal patch by quantifying its effectiveness and its adverse event profile after the switch from oral dopamine agonist treatment in IPD patients with reported gastrointestinal complaints.;Secondary Objective: Not applicable;Primary end point(s): Efficacy variables : Primary efficacy variables: • Change from Baseline to end of Week 6 in: - the assessment of severity of gastrointestinal complaints for any reason as per visual analogue scale (VAS) - Unified Parkinson Disease Rating Scale III score(UPDRS) - EQ-5D™(measurement of patient general health outcome) - Parkinson's disease questionnaire-8 score, short form(PDQ-8) • Change versus Baseline assessed at end of Week 6 in: . Clinical Global Impression . Patient's Global Impression Secondary efficacy variables: • Change from Baseline to end of Week 2 in: - the assessment of severity of gastrointestinal complaints for any reason as per visual analogue scale (VAS) - Unified Parkinson Disease Rating Scale III score(UPDRS) - EQ-5D™(measurement of patient general health outcome) - Parkinson's disease questionnaire-8 score, short form(PDQ-8) • Change versus Baseline assessed at end of Week 2 in: . Clinical Global Impression . Patient's Global Impression Other efficacy variables: • Scores over time, single item scores over time, and change from Baseline of single item scores for UPDRS III, EQ-5D™, and PDQ-8 • Single item scores over time and change from Baseline of single item scores for selected items of the Rome-III diagnostic questionnaire (introductory items and items of part A and B). Incidence of the following gastrointestinal symptoms: nausea, vomiting, abdominal pain, dysphagia, and other gastrointestinal complaints. Safety variables: • Incidence of adverse events (AEs) • Change from Baseline in vital signs • Findings in physical and neu | — |
Countries
Germany
Outcome results
None listed