idiopathic Parkinson´s disease MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Neupro 2 mg/24 h transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
SCHWARZ PHARMA Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill the following inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his 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 and = 80 years of age. 4. Female subject is surgically sterile (uterus removed or bilateral tubal ligation), postmenopausal (at least 2 years without periods), or must practice adequate methods of contraception if of childbearing potential (defined as consistent use of 2 (combined) effective methods of contraception including 1 hormonal method (oral, implant, injections, intrauterine device) and 1 barrier method). 5. Subject has idiopathic Parkinson’s disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism. 6. Subject is American Society of Anesthesiologists (ASA) stage II through III as determined by the investigator. 7. Subject is currently taking medication for PD (eg, levodopa, dopamine agonists, anticholinergics, monoamine oxidase B (MAO-B) inhibitors, entacapone, N-methyl-d-aspartate [NMDA] antagonists). 8. Subject is scheduled for an operation requiring general anesthesia 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: Subjects are not permitted to enroll in the trial if any of the following criteria are met: 1. Subject has previously been treated with rotigotine. 2. Subject has participated in another trial of an investigational drug within the last 28 days prior to Screening or is currently participating in another trial using an investigational drug. 3. Female subject is pregnant or nursing, or is of childbearing potential and is not practicing adequate methods of contraception. 4. Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes), metabolic neurodegenerative disorders (eg, Wilson’s disease), encephalitis, cerebrovascular disease or degenerative disease (eg, progressive supranuclear palsy). 5. Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): reserpine, alpha-methyldopa, metoclopramide, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, budipine or amphetamine. 6. Presence of clinically relevant hepatic or renal dysfunction (as defined as an ALT and/or AST greater than 5 times the upper limit of the reference range or Child/Pugh B and C, and/or creatinine clearance of 24 hours). 10. Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject’s ability to participate in this trial. 11. Subject with psychosis requiring therapy in the medical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot study is designed to provide exploratory information on the feasibility of perioperative rotigotine treatment in a limited number of subjects with PD. In addition, efficacy and safety information on the use of rotigotine as part of the perioperative management of Parkinson’s Disease will be collected.;Secondary Objective: Other variables in this trial are plasma concentration of rotigotine and apparent dose. These variables will be analyzed using descriptive methods only. The variables including summary statistics will be displayed (n, arithmetic mean, standard deviation, minimum, median, and maximum).;Primary end point(s): • Feasibility assessment questionnaire by the anesthesiologist • Feasibility assessment questionnaire by the neurologist • Feasibility assessment questionnaire by the subject • Plasma concentrations of rotigotine • Apparent dose • Observation and assessment of AEs • Laboratory parameters • Vital sign measurements (blood pressure, pulse) • Physical examination findings • 12-lead ECG | — |
Countries
Germany
Outcome results
None listed