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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT01244269
Eligibility Criteria:
Inclusion Criteria:
* Patients with stages 2-3 Parkinson's disease as defined by the Hoehn \&Yahr staging system (Hoehn \&Yahr, 1967).
* Age less than or equal to 75 years.
* Subjects who are willing and able to provide, in writing, informed consent.
* Subjects who are willing and able to be confined to the clinical research unit as required by the protocol and to complete all procedures required on an outpatient basis.
Exclusion Criteria:
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies and excluding seasonal allergies).
* Subjects with a history of substance abuse or dependence or a positive urine screen for drugs of abuse.
* A history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
* Subjects with a documented allergy to methylphenidate or one of the product excipients.
* Subjects with any medical condition affecting drug absorption (e.g. gastrectomy).
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
* Use of a monoamine oxidase inhibitor or other interacting medication within the preceding 14 days or 5 half-lives (whichever is longer).
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT01244269
Study Brief:
Protocol Section:
NCT01244269