Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT04183634
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
Exclusion Criteria:
* Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
* History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
* History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
* History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04183634
Study Brief:
Protocol Section:
NCT04183634