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Requip XL (Ropinirole Hydrochloride) - Summary



REQUIP (ropinirole) and REQUIP XL (ropinirole extended release) is an orally administered non-ergoline dopamine agonist.

REQUIP XL (ropinirole extended-release tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
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Media Articles Related to Requip XL (Ropinirole)

New study calls for partnering of Parkinson's disease research community with patient groups to improve effectiveness of clinical trials
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.06.25]
Despite an urgent need for new medications, clinical trials in Parkinson's disease (PD) have a relatively low rate of success.

New knowledge: Parkinson's disease may begin in the gut
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2015.06.24]
A major epidemiological registry-based study from Aarhus University and Aarhus University Hospital indicates that Parkinson's disease begins in the gastrointestinal tract; the study is the largest in...

FDA Approves Brain Stimulation Device for Parkinson's Disease
Source: MedicineNet Clinical Trials Specialty [2015.06.15]
Title: FDA Approves Brain Stimulation Device for Parkinson's Disease
Category: Health News
Created: 6/12/2015 12:00:00 AM
Last Editorial Review: 6/15/2015 12:00:00 AM

Parkinson's Disease Quiz: Test Your Medical IQ
Source: MedicineNet amantadine Specialty [2015.02.20]
Title: Parkinson's Disease Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 8/23/2011 12:53:00 PM
Last Editorial Review: 2/20/2015 4:38:06 PM

Scripps Florida scientists' 'mad cow' discovery points to possible neuron killing mechanism behind Alzheimer's and Parkinson's diseases
Source: CJD / vCJD / Mad Cow Disease News From Medical News Today [2015.02.16]
Scientists from the Florida campus of The Scripps Research Institute (TSRI) have for the first time discovered a killing mechanism that could underpin a range of the most intractable...

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Published Studies Related to Requip XL (Ropinirole)

[Efficacy and safety of ropinirole in the treatment of Parkinson's disease: a multi-center, randomized, double-blind and bromocriptine-controlled trial]. [Article in Chinese] [2013]
Parkinson's disease... CONCLUSIONS: Ropinirole is both effective and safe in the treatment of Chinese

The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study. [2013]
Parkinson's disease (PD) not optimally controlled with L-dopa... CONCLUSIONS: This study demonstrated for the first time in Chinese subjects that

PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease. [2011.06]
BACKGROUND: PREPARED was a randomized, parallel-group, double-blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD)... CONCLUSIONS: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving >/= 20% maintained reduction in time spent "off" compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L-dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. Copyright (c) 2011 Movement Disorder Society.

Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. [2011.06]
Comorbid depressive symptoms in restless legs syndrome (RLS) remain a treatment challenge, as some antidepressants aggravate RLS symptoms...

Pramipexole versus ropinirole: polysomnographic acute effects in restless legs syndrome. [2011.04]
BACKGROUND: Pramipexole and ropinirole have become the first-line treatment for restless legs syndrome. The aim of this study was to perform the first direct comparison between these two molecules in restless legs syndrome... No significant side effects, except for mild morning nausea (2 patients treated with ropinirole, 3 with pramipexole, and 1 with placebo), were reported.

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Clinical Trials Related to Requip XL (Ropinirole)

Study to Observe the Effect of Requip PDŽ Once-daily (QD) Versus Twice-daily (BID) [Recruiting]
1. In order to observe the benefit, side effects, and patient preference of Requip PD when used in QD or BID dosing

2. In order to estimate the conversion rate of dopamine agonists into Requip PD

SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole [Recruiting]
The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole for patients switched from pramipexole to ropinirole in patients with moderate to severe primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched from one dopamine agonist to an equipotent dose of another.

A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease [Recruiting]
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa [Recruiting]
This is a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged Release (PR) with that of placebo as adjunctive therapy to L-dopa in Parkinson's disease patients not optimally controlled on L-dopa. This study will be conducted in China. Subjects will have total 14 visits over the 26 week duration of the study.

Following screening, eligible subjects will receive study medication during the fourteen day placebo run-in period which they will be instructed to take in addition to their background L-dopa. If subjects are still eligible at the end of the placebo run-in period they will be randomized (1: 1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day. If sufficient symptomatic control is not achieved or maintained at a dose of 6mg/day of ropinirole PR, the daily dose should be increased by 2mg at weekly or longer intervals up to a dose of 8mg/day. If sufficient symptomatic control is still not achieved or maintained at a dose of 8mg/day of ropinirole PR, the daily dose should be increased by 4mg at two weekly or longer intervals. Further dose titration should not be conducted within the final 8 weeks of the treatment phase. The maximum recommended daily dose is 24mg.

The planned reduction in L-dopa dose will begin once subjects are titrated to Dose Level 4 or Dose Level 5 of study medication. For each increase in study medication, there will be a corresponding decrease in L-dopa. If loss of symptom control occurs with the reduction in the background L-dopa dose, the dose of study medication should be increased to the next higher dose level with no adjustment in the dose of L-dopa. If loss of symptom control persists, subjects should be titrated up an additional dose level. Subjects who do not experience an improvement in symptoms following upward titration by 2 dose levels of study medication, should be "rescued" with L-dopa.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit if the patient did not enter extension study and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication. The extension study aim to evaluate the safety profile of ReQuip PR during long-term treatment in subjects with advanced parkinson's disease.

A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease [Recruiting]
This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1. 7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

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Reports of Suspected Requip XL (Ropinirole) Side Effects

Medication Residue (8)Somnolence (7)Drug Ineffective (6)OFF Label USE (6)Drug Administration Error (5)Hallucination (5)Nausea (5)Hallucination, Visual (5)Insomnia (5)Malaise (4)more >>

Page last updated: 2015-06-25

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