| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00632736 | An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease | PHASE3 | COMPLETED | 419 | — | — | Feb 1, 2004 | Mar 1, 2010 | Mar 23, 2017 | 75 | United States, Belgium +7 |
| NCT00650104 | Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 | PHASE3 | COMPLETED | 76 | — | — | May 1, 2002 | Mar 1, 2009 | May 6, 2013 | 10 | United States |
| NCT01371682 | A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda | PHASE1 | COMPLETED | 50 | — | — | Sep 18, 2009 | Dec 2, 2009 | Jun 19, 2018 | 1 | Belgium |
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2
| Arm | Type | Description |
|---|---|---|
| Ropinirole XL (formerly CR) | ACTIVE_COMPARATOR | Ropinirole XL (formerly CR) |
| Active | ACTIVE_COMPARATOR | Open label medication - Ropinirole CR |
| Session 1 | OTHER | Ropinirole manufactued at Crawley will be compared to that manufactured at Aranda |
| Session 2 | OTHER | Ropinirole manufactured at Crawley will be compared to that manufactured at Aranda. |
| Name | Type | Description |
|---|---|---|
| Ropinirole XL (formerly CR) | DRUG | - |
| Ropinirole XL | DRUG | Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda. |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down...