Clinical neuropharmacology
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Clin Neuropharmacol · Jan 2011
Randomized Controlled Trial Multicenter StudyA 52-week study of gabapentin enacarbil in restless legs syndrome.
This open-label, multicenter, 52-week extension study (NCT00333359) assessed the long-term safety and efficacy of gabapentin enacarbil in subjects with moderate-to-severe primary restless legs syndrome (RLS). ⋯ Gabapentin enacarbil was generally safe and well tolerated and improved RLS symptoms in subjects with moderate-to-severe primary RLS for up to 64 weeks of treatment.
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Clin Neuropharmacol · Nov 2009
Randomized Controlled Trial Multicenter StudyGabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trial.
Assess the efficacy and tolerability of gabapentin enacarbil (GEn), a transported prodrug of gabapentin with improved gabapentin exposure, in adults with moderate-to-severe primary restless legs syndrome. ⋯ Gabapentin enacarbil at 1200 mg significantly improved restless legs syndrome symptoms compared with placebo. Efficacy outcomes for GEn at 600 mg were similar to placebo. Both GEn doses were generally well tolerated.
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Clin Neuropharmacol · Sep 2008
Randomized Controlled Trial Multicenter Study Comparative StudyPatient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome.
To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes. ⋯ Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.
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Clin Neuropharmacol · Sep 2007
Multicenter StudyOvernight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease.
To assess safety, tolerability, and efficacy outcomes of an overnight switch from oral ropinirole, pramipexole, or cabergoline to rotigotine, a dopaminergic agonist with transdermal delivery over 24 hours in subjects with established Parkinson disease (PD). ⋯ Subjects and clinicians found the overnight switch to rotigotine convenient, well tolerated, and effective for control of PD signs and symptoms for subjects previously receiving low-to-moderate doses of oral dopaminergic agonists.
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Clin Neuropharmacol · Feb 1997
Randomized Controlled Trial Multicenter Study Clinical TrialEarly combination of bromocriptine and levodopa in Parkinson's disease: a prospective randomized study of two parallel groups over a total follow-up period of 44 months including an initial 8-month double-blind stage.
To determine if the combination of levodopa (LD) plus bromocriptine (Br) in the early stages of Parkinson's disease (PD) permits reduction of LD dosage and consequently results in fewer motor fluctuations and dyskinesias, a double-blind, multicenter prospective study in 50 PD patients who had responded favorably to LD while under treatment with that drug for < or = 6 months was undertaken. Patients were randomized into two parallel groups (LD alone and LD plus Br). During the first placebo-controlled stage of the study lasting 8 months, association of a fixed dose of Br (15 mg/day) in the LD regimen did not allow a significant reduction in the daily LD dose. ⋯ At that point in time, the mean dose of Br had been increased by 9.2 mg in the combined treatment group, and the mean dose of LD was 40.7% lower than in the group receiving LD alone. On subsequent evaluations, the number of patients with dyskinesias or describing wearing-off fluctuations severe enough to require changes in treatment was lower than in the group under combined therapy, the differences being significant after 20 and 44 months, respectively (36.8 vs. 9.5 and 47.3 vs. 14.2%). Our results support early combined LD-Br therapy in PD, but no conclusions can be drawn as to whether this dopamine agonist exerts a preventive effect on the late side effects of LD or has another mechanism of action.