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 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT01154166
Eligibility Criteria:
Inclusion Criteria:
* Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening.Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device \[IUD\], or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception \[i.e. Norplant System\]), during the study and for at least one month prior to randomisation and one month following completion of the study.
* Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn \& Yahr criteria Stages II-IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
* Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
* Provide written informed consent for this study
* A minimum of 3 hours awake time"off " for each diary day recorded during the Placebo Run-In Period.
* Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
Exclusion Criteria:
* Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
* Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson.s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer);
* Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG;
* Unstable liver disease, cirrhosis, known biliary abnormalities(except Gilbert's syndrome or asymptomatic gallstones) or AST or ALT\>2xULN or alk phos and bilirubin\>1.5 xULN
* Recent history of severe dizziness or fainting due to postural hypotension on standing.
* Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
* Recent history or current evidence of drug abuse or alcoholism.
* Consumption of any dopamine agonist within four weeks of the screening visit.
* Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole PR.
* Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
* Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01154166
Study Brief:
Protocol Section:
NCT01154166