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 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT01286935
Eligibility Criteria:
Inclusion Criteria:
* The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
* The patient was compliant with taking study medication in Study 016.
* The patient is willing to participate in the study and signed an approved Informed Consent form.
Exclusion Criteria:
* The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
* The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
* The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT01286935
Study Brief:
Protocol Section:
NCT01286935