Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ropinirole immediate release
Ropinirole prolonged release · 3 trials · 2 indications
Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.
Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.
| Arm | Type | Description |
|---|---|---|
| Ropinirole PR/XR | EXPERIMENTAL | - |
| Ropinirole | EXPERIMENTAL | single dose .25mg of IR formulation, .05mg of RLS controlled release |
| Name | Type | Description |
|---|---|---|
| Ropinirole prolonged release | DRUG | - |
| ropinirole immediate release | DRUG | - |
| Ropinirole prolonged release/extended release(PR/XR) | DRUG | Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal). |
Inclusion criteria: * Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa. Exclusion criteria: * Patients with late stage advanced Parkinson's disease with incapac...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
Ropinirole prolonged release is used to treat Parkinson disease. It is an extended-release oral formulation developed by GSK plc, and it is studied both as monotherapy in early Parkinson disease and in patients with advanced Parkinson disease. It is a small molecule therapy in the neurology therapeutic area.
Ropinirole prolonged release targets the dopamine receptors DRD2, DRD3, and DRD4. It acts as a dopamine receptor agonist, meaning it stimulates these receptors. This agonist activity at DRD2, DRD3, and DRD4 underlies its use in Parkinson disease, where dopaminergic signaling is impaired.
Ropinirole prolonged release is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this extended-release formulation in Parkinson disease.
Ropinirole prolonged release has been evaluated in Phase 3 clinical development. It is an investigational extended-release formulation studied in Parkinson disease, and the trials listed for it are completed rather than active. No trials for this formulation are currently active.
Ropinirole prolonged release has been studied in two completed trials. NCT00331149 was a Phase 3 comparison of ropinirole immediate release with ropinirole prolonged release in patients with advanced Parkinson disease, enrolling 343 patients across Europe and other countries. NCT00434304 was a Phase 2 monotherapy evaluation in Japan enrolling 62 patients.
Yes. Ropinirole prolonged release is also known as ropinirole extended release, abbreviated PR or XR. These names refer to the same extended-release oral formulation of ropinirole developed by GSK plc for Parkinson disease.