A randomized controlled study of pergolide in patients with restless legs syndrome

Wetter, Thomas C.; Stiasny, Karin; Winkelmann, Juliane; Buhlinger, A.; Brandenburg, U.; Penzel, T.; Medori, Rossella; Rubin, M.; Oertel, Wolfgang H.; Trenkwalder, Claudia

doi:10.1212/wnl.52.5.944

Cited by 201 publications

(110 citation statements)

References 29 publications

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“…The significant reduction of PLM under cabergoline treatment is in line with recent findings for cabergoline and other dopamine agonists in patients with PLM due to restless legs syndrome (Wetter et al, 1999;Montplaisir et al, 1999;Stiasny et al, 2000). As the frequency of arousals was not reduced during cabergoline therapy, this might indicate that PLMS are not the major cause for sleep fragmentation in PD patients.…”

Section: Discussionsupporting

confidence: 88%

“…This may be interpreted as a reduced sleep state stability of cabergoline and is in line with increased spontaneous awakenings despite greatly reduced PLM in patients with restless legs syndrome undergoing treatment with the dopamine agonist pergolide (Wetter et al, 1999). As nocturnal akinesia is a major problem in patients with PD (Laihinen et al, 1987), an increase in movement time as measured in this study may indicate a treatment-induced restoration of nocturnal mobility.…”

Section: Discussionsupporting

confidence: 62%

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The Effect of Cabergoline on Sleep, Periodic Leg Movements in Sleep, and Early Morning Motor Function in Patients with Parkinson's Disease

Högl

Rothdach

Wetter

et al. 2003

Neuropsychopharmacol

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To investigate the effect of the dopamine D2 and D1 receptor agonist cabergoline on sleep, periodic leg movements (PLMs) in sleep, and early morning motor performance in patients with Parkinson's disease (PD). It was hypothesized that cabergoline had long-lasting beneficial effects on sleep and PLMs in sleep in patients with PD, after a single evening intake. A total of 15 patients with idiopathic PD underwent two nights of polysomnography and motor tests (UPDRS, tapping test) before and after 6-8 weeks of treatment with cabergoline (dosage: 3-6 mg/day). Additionally, patients completed a subjective sleep visual analog scale (VAS) before and during cabergoline treatment. Compared to baseline values, treatment with cabergoline did not change sleep efficiency or the amount of stage 1 and stage 2 sleep. The number of awakenings (22.4 7 10.1 vs 32.5 7 13.3, po0.05) and stage shifts (119 7 42 vs 148 7 46, po0.05) were increased during treatment with cabergoline, and PLMs in sleep were reduced (PLM index 34.9 7 44.9 vs 6.7 7 4.2 per hour, po0.05). Cabergoline significantly improved early morning motor function, and in spite of increased phase shifts and awakenings, patients felt significantly more refreshed in the morning during cabergoline therapy. Cabergoline slightly fragmented sleep, without altering its total amount. The functional significance of this finding is uncertain. The subjective quality of sleep improved, and periodic limb movements in sleep decreased.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 62%

The Effect of Cabergoline on Sleep, Periodic Leg Movements in Sleep, and Early Morning Motor Function in Patients with Parkinson's Disease

Högl

Rothdach

Wetter

et al. 2003

Neuropsychopharmacol

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“…The dopamine D1/D2 agonist pergolide (halflife 7-16 hours) already showed a marked effect both in idiopathic and uremic RLS especially in regard to these problems. 6,7 To evaluate the efficacy and tolerability of the longer-acting dopamine (D1)/D2 agonist cabergoline (halflife>65 hours), we investigated nine patients who previously had insufficiently been treated with and partly developed augmentation under levodopa in an open label dose finding pilot trial.…”

Section: Introductionmentioning

confidence: 99%

Treatment of Idiopathic Restless Legs Syndrome (RLS) with the D2-agonist Cabergoline — An Open Clinical Trial

Stiasny

Röbbecke

Schüler³

et al. 2000

Sleep

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A DESIRE TO MOVE THE LEGS usually associated with paresthesias/dysesthesias, 2 motor restlessness, 3 worsening or exclusive presence of symptoms at rest (i.e., lying, sitting) with at least partial or temporary relief by activity, and 4 worsening of symptoms during the evening or night. According to the International RLS Study Group these four minimal criteria already allow clinical diagnosis. 1 Sensory and motor symptoms in RLS often result in severe sleep disturbances with prolonged sleep latency, decreased total sleep time with reduced or absent slow wave sleep and decreased sleep efficiency. Almost all RLS patients present periodic leg movements (PLM) during sleep and also while being awake. 2 In RLS patients the number of PLM and related parameters are often used as a marker for the severity of RLS since PLM are frequently associated with nocturnal arousals or awakenings. If present during wakefulness PLM may prevent patients from falling asleep. Therefore, performing polysomnography is mandatory to evaluate the efficacy of drug therapies. Various agents have been used to treat RLS. However, no substance is approved for this indication so far. The drug of first choice is levodopa in conjunction with a dopa decarStudy objectives: To define the effective dose of cabergoline and to evaluate the tolerability and efficacy of cabergoline in patients with restless legs syndrome (RLS). Design: Treatment of idiopathic RLS patients with cabergoline in a 12-week open label trial. Patients on levodopa therapy were allowed to either stop levodopa prior to study entry or to continue, taper or discontinue levodopa during the study. Efficacy parameters were assessed by polysomnography and subjective ratings at baseline and at week 12. Primary efficacy parameters were the number of PLM and total sleep time. Setting: Dept. of Neurology, Sleep Disorders Center Patients: Nine patients with moderate to severe RLS (age 38.1 to 64.3 years, mean 54.1 years) who had experienced insufficient benefit under levodopa therapy and/or in part developed daytime augmentation participated. At study entry five patients were still under levodopa therapy (400-800 mg). Interventions: Up-titration of cabergoline (single evening dose) until RLS symptoms clearly improved. Initial comedication with domperidone 20 mg t.i.d. Measurements and Results:At the endpoint all patients were on cabergoline monotherapy (mean dosage 2.1 mg, range 1 to 4 mg). Domperidone was stopped in all patients due to good tolerability. Polysomnographic data showed a significant reduction of the number of periodic leg movements (PLM) (195.8±109.1 (baseline) vs. 26.4±40.2 (12 weeks cabergoline monotherapy; p = 0.002), PLM arousals (51.7±42.3 vs. 6.4±11.2; p=0.017) and PLM awakenings (10.4±7.8 vs. 1.0±1.7; p=0.001). Total sleep time was prolonged (302.7±50.7 vs. 379.4±59.8 min; p=0.018), sleep latency shortened (42.4±49.1 vs. 16.3±22.8 min; p=0.214) and sleep efficiency increased (63.1±10.5 vs. 79.1±12.5%; p = 0.017). All patients reported a impressive relief or became free of ...

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“…Details of the placebo analysis of 12 RLS drug trials [17][18][19][20][21][22][23][24][25][26][27][28] and the two VS trials 4,29 have been previously published. Controls for the drug trials were pharmacologically inert pills identical in appearance to study drugs.…”

Section: Trials Selectedmentioning

confidence: 99%

Sleep improvement for restless legs syndrome patients. Part IV: meta-analysis comparison of effect sizes of vibratory stimulation sham pads and placebo pills

Segawa¹,

Burbank²

2014

JPRLS

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Purpose: To determine whether sham pads used as controls in randomized clinical trials of vibratory stimulation to treat patients with sleep loss associated with restless legs syndrome perform differently than placebo pills used in comparable restless legs syndrome drug trials. Patients and methods: Sham pad effect sizes from 66 control patients in two randomized clinical trials of vibratory stimulation were compared with placebo responses from 1,024 control patients in 12 randomized clinical drug trials reporting subjective sleep measurement scales. Control patient responses were measured as the standardized difference in means corrected for correlation between beginning and ending scores and for small sample sizes. Results: For parallel randomized clinical trials, sham effects in vibratory stimulation trials were not significantly different from placebo effects in drug trials (0.37 and 0.31, respectively, Q between subgroups =0.25, P Q $0.62). Placebo effect sizes were significantly smaller in crossover drug trials than sham effect sizes in parallel vibratory stimulation trials (0.07 versus 0.37, respectively, Q between subgroups =4.59, P Q #0.03) and placebo effect sizes in parallel drug trials (0.07 versus 0.31, respectively, Q between subgroups =5.50, P Q #0.02). Conclusion: For subjective sleep loss assessments in parallel trials, sham pads in vibratory stimulation trials performed similarly to placebo pills in drug trials. Trial design (parallel versus crossover) had a large influence on control effect sizes. Placebo pills in crossover drug trials had significantly smaller effect sizes than sham pads in parallel vibratory stimulation trials or placebo pills in parallel drug trials.

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A randomized controlled study of pergolide in patients with restless legs syndrome

Abstract: Pergolide given as a single low-to-medium bedtime dose in combination with domperidone provides a well-tolerated and effective treatment of sensorimotor symptoms and sleep disturbances in patients with primary RLS.

Cited by 201 publications

References 29 publications

The Effect of Cabergoline on Sleep, Periodic Leg Movements in Sleep, and Early Morning Motor Function in Patients with Parkinson's Disease

The Effect of Cabergoline on Sleep, Periodic Leg Movements in Sleep, and Early Morning Motor Function in Patients with Parkinson's Disease

Treatment of Idiopathic Restless Legs Syndrome (RLS) with the D2-agonist Cabergoline — An Open Clinical Trial

Sleep improvement for restless legs syndrome patients. Part IV: meta-analysis comparison of effect sizes of vibratory stimulation sham pads and placebo pills

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