Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ropinirole XL · 3 trials · 2 indications
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...
Ropinirole XL is an investigational extended-release small molecule being developed for the treatment of Parkinson Disease. It is a dopamine agonist formulated for prolonged release. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Ropinirole XL is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this extended-release formulation for Parkinson Disease.
Ropinirole XL is in Phase 3 clinical development for Parkinson Disease. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 program includes completed long-term safety extension studies, with a total of 545 participants enrolled across all trials.
Ropinirole XL has been studied in three completed clinical trials. NCT00632736 was a Phase 3 open-label study evaluating long-term safety in 419 Parkinson Disease patients across multiple countries. NCT00650104 was a Phase 3 long-term extension study in 76 US patients. NCT01371682 was a Phase 1 bioequivalence study in 50 healthy volunteers in Belgium.
Yes, Ropinirole XL was formerly referred to as Ropinirole CR, as indicated in the clinical trial titles. The extended-release formulation has been studied under both names in Phase 3 trials for Parkinson Disease. The drug is being developed by GSK plc.