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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05273957
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Living in the Lombardy region (Northern Italy)
* Duration of Parkinson's disease, atypical or secondary parkinsonism ≥ 3 years
* Presence of at least (i) n=1 motor complication and/or (ii), n=2 non-motor symptoms, defined as follows:
(i) Motor complication:
* Motor fluctuations
* ≥ 2 Falls in the last 6 months
* Dysphagia
(ii) Non Motor symptoms
* Non-motor fluctuations
* ≥ 2 items of the non-motor symptoms scale with a score ≥ 2
Exclusion Criteria:
* Hoehn and Yahr Stage = 5 in the ON-medication condition
* Psychiatric comorbidity or other neurological chronic diseases that, in the opinion of the recruiting neurologist, could compromise the study participation.
* Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion).
* Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05273957
Study Brief:
Protocol Section:
NCT05273957