Efficacy of rotigotine transdermal system in severe restless legs syndrome: A randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe

Oertel, Wolfgang H.; Beneŝ, Heike; Garcı́a-Borreguero, Diego; Geisler, Peter; Högl, Birgit; Saletu, B.; Trenkwalder, Claudia; Sommerville, Kenneth W.; Schollmayer, Erwin; Kohnen, Ralf; Stiasny‐Kolster, Karin

doi:10.1016/j.sleep.2007.04.010

Cited by 102 publications

(99 citation statements)

References 28 publications

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“…First, improvement in RLS (mean reduction in the IRLS score of 14 points; remission rate, 52%) was similar to the improvement reported during treatment with dopamine agonists 28,29 . Second, PLM, which is an objective marker of RLS, also improved significantly, although this was to a lesser extent than that generally observed with dopaminergic drugs.…”

Section: Discussionsupporting

confidence: 70%

Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome

et al. 2015

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Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome, Sleep Medicine (2015), http://dx.doi.org/doi: 10.1016/j.sleep.2015.08.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Neurocenter of Southern Switzerland (Lugano). Patient and Methods:Nineteen women in the third trimester of pregnancy with moderateto-severe RLS and serum ferritin levels <35 µg/L or hemoglobin (Hb) <11.0 g/dl were included in the study. RLS was graded according to the International Restless Legs Syndrome (IRLS) Study Group rating scale. All participants had a score of ≥20 or had RLS ≥3 times/week. Depending on Hb levels, 500 or 700 mg of FCM was administered over 20 min. The primary endpoint was a ≥50% reduction in the mean IRLS score 1 week after FCM infusion. Secondary endpoints included periodic limb movements (PLMs; assessed using nocturnal foot actigraphy), sleep quality (assessed using the Pittsburgh Sleep Quality Index), and safety. Results:The IRLS score decreased from 23 ± 7 (baseline) to 13 ± 7 (P < 0.01), whereas the PLM index decreased from 35 ± 26 (baseline) to 25 ± 20 (P < 0.001). Significant improvement in sleep quality was also reported (P < 0.029), and treatment was well tolerated. Three serious adverse events were reported but were considered unrelated to treatment. Conclusions:These data provides promising evidence of the safety and efficacy of FCM for moderate-to-severe RLS in pregnant women with iron deficiency or anemia. A future placebo-controlled study is therefore warranted.

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Section: Discussionsupporting

confidence: 70%

Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome

et al. 2015

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“…The efficacy and safety of the rotigotine transdermal patch were further tested in a double-blind, randomized, parallel-group, multicenter, 6-week dose-finding trial [23]. The primary efficacy measure was the total score on the IRLS.…”

Section: Clinical Efficacy Of Rotigotinementioning

confidence: 99%

Rotigotine Transdermal Patch for the Treatment of Restless Legs Syndrome

et al. 2014

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Rotigotine, a nonergot dopamine agonist, has been developed as a novel transdermal formulation. The rotigotine transdermal patch has received EMA and FDA marketing authorization for the treatment of adult patients with early or advanced Parkinson's disease or with moderate-to-severe restless legs syndrome (RLS). This review comprises an overview of the pharmacokinetics, the pharmacodynamics and the clinical efficacy and safety of the rotigotine transdermal patch for RLS. Its source material was identified by a PubMed search for the terms ‘rotigotine' and ‘RLS'. The rotigotine transdermal patch demonstrates clinical efficacy alongside a good tolerability profile. Application site reactions were the most frequent adverse events, and they were considered mild to moderate in the majority of cases. In summary, the rotigotine transdermal patch offers a safe and efficacious alternative for the treatment of RLS. Further studies should focus on the possibility that continuous dopamine stimulation by means of transdermal patches might have an influence on RLS augmentation rates.

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“…However, augmentation may occur even at the lowest doses of dopamine agonists. A new dopamine agonist, the rotigotine patch (Neupro, UCB, Inc., Smyrna, GA) has just been approved by the FDA (April 2012) for treating moderate-to-severe RLS, and numerous studies support its efficacy and safety [101][102][103][104][105][106]. The patch is available in 1 mg, 2 mg, and 3 mg per 24-h doses and should be started at 1 mg/24 h and then increased on a weekly basis as needed to a maximum dose of 3 mg/24 h. Although many patients with moderate-to-severe RLS complain predominately of evening and/or bedtime symptoms, most have daytime symptoms that become bothersome when trying to perform sedentary activities or tasks, and would thus benefit from this medication.…”

Section: Dopamine Agonistsmentioning

confidence: 99%

Strategies for the Treatment of Restless Legs Syndrome

Buchfuhrer

2012

Neurotherapeutics

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Restless legs syndrome (RLS) is a common neurological disorder of unknown etiology that is managed by therapy directed at relieving its symptoms. Treatment of patients with milder symptoms that occur intermittently may be treated with nonpharmacological therapy but when not successful, drug therapy should be chosen based on the timing of the symptoms and the needs of the patient. Patients with moderate to severe RLS typically require daily medication to control their symptoms. Although the dopamine agonists, ropinirole and pramipexole have been the drugs of choice for patients with moderate to severe RLS, drug emergent problems like augmentation may limit their use for long term therapy. Keeping the dopamine agonist dose as low as possible, using longer acting dopamine agonists such as the rotigotine patch and maintaining a high serum ferritin level may help prevent the development of augmentation. The α2δ anticonvulsants may now also be considered as drugs of choice for moderate to severe RLS patients. Opioids should be considered for RLS patients, especially for those who have failed other therapies since they are very effective for severe cases. When monitored appropriately, they can be very safe and durable for long term therapy. They should also be strongly considered for treating patients with augmentation as they are very effective for relieving the worsening symptoms that occur when decreasing or eliminating dopamine agonists.

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Efficacy of rotigotine transdermal system in severe restless legs syndrome: A randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe

Cited by 102 publications

References 28 publications

Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome

Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome

Rotigotine Transdermal Patch for the Treatment of Restless Legs Syndrome

Strategies for the Treatment of Restless Legs Syndrome

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