An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS

• Conditions: idiopathic Parkinson´s disease; MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2006-005438-19-DE
• Lead Sponsor: SCHWARZ PHARMA Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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 <30ml/min).
7. Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch.
8. Subject is scheduled for a surgical procedure (SPP) that requires magnetic resonance imaging or cardioversion.
9. Subject has a high probability to require extended postoperative ventilation (>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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified