EUCTR2006-005438-19-DEActive, not recruitingNot Applicable
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
SCHWARZ PHARMA Deutschland GmbH0 sites30 target enrollmentStarted: March 28, 2007Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial CancerCTIS2022-502453-33-00Genmab A/S78
Active, not recruiting
Phase 1
A pilot clinical trial of inhaled molgramostim in patients with antibiotic-resistant bacterial infection.Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infectionMedDRA version: 20.1Level: PTClassification code 10062207Term: Mycobacterial infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-003374-14-GBSavara ApS30
Recruiting
Phase 3
Whether cooling the scalp during chemotherapy can reduce hairfall in patients with cancerCTRI/2023/05/053011JIPMER
Active, not recruiting
Not Applicable
An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - NDMedDRA version: 6.1Level: PTClassification code 10053395multiple sclerosisEUCTR2005-005679-13-ITOSPEDALE S. RAFFAELE40
Active, not recruiting
Phase 1
A pilot study to assess the efficacy and safety of OBE2109 in subjects with rectovaginal endometriosis.EUCTR2017-004043-21-FRObsEva SA9