Clinical neuropharmacology
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Clin Neuropharmacol · Jan 2014
Randomized Controlled Trial Multicenter StudyLong-term safety of rivastigmine in parkinson disease dementia: an open-label, randomized study.
This study investigated the long-term safety of rivastigmine (12 mg/d capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia. ⋯ This study supports the long-term safety of rivastigmine in Parkinson disease dementia. The rate of worsening of motor symptoms was in the range expected due to the natural progression of Parkinson disease, no new or unexpected safety issues emerged in the long-term.
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Clin Neuropharmacol · Sep 2013
Randomized Controlled TrialAcute treatment of trigeminal neuralgia with onabotulinum toxin A.
A double-blind, randomized, placebo-controlled study of patients with essential trigeminal neuralgia and treatment with a single injection of onabotulinum toxin A (BTX) was carried out. The efficacy, safety, and tolerability of either 1 mL 0.9% saline plus 50 U of BTX or only 1 mL of 0.9% saline injected subcutaneously in the affected area were evaluated. Cases with involvement of the third branch of the trigeminal nerve also received intramuscularly either 10 U of BTX or matching placebo in the masseter muscle, ipsilateral to the pain location. ⋯ Two months after the intervention, a trend to statistical significance was observed for the VAS mean values in subjects treated with BTX and those who received placebo (VAS 4.9 vs 6.63, t test, P = 0.07). Three months after the injection, significant differences were observed in the average VAS score for subjects treated with BTX and those treated with placebo (VAS 4.75 vs 6.94, respectively; t test, P = 0.01). Onabotulinum toxin A was well tolerated and seems to be a safe and useful therapy for patients with essential trigeminal neuralgia.
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Clin Neuropharmacol · Jan 2013
Randomized Controlled Trial Multicenter StudySafety and pharmacology of a single intravenous dose of ponezumab in subjects with mild-to-moderate Alzheimer disease: a phase I, randomized, placebo-controlled, double-blind, dose-escalation study.
Ponezumab is a humanized antiamyloid beta (Aβ) monoclonal antibody designed to treat Alzheimer disease (AD). ⋯ A 2-hour infusion of 0.1 to 10 mg/kg ponezumab was well tolerated in subjects with mild-to-moderate AD. Plasma pharmacokinetic profile was approximately linear. Plasma Aβ increased with dose, and CSF Aβ increased at the highest dose, suggesting that intravenous ponezumab alters central Aβ levels.
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Clin Neuropharmacol · Jul 2012
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome.
The objective of this study was to determine steady-state gabapentin exposures and corresponding relief of symptoms and safety profile produced by 4 dose levels of gabapentin enacarbil (GEn) in subjects with restless legs syndrome (RLS). ⋯ Gabapentin exposure was approximately proportional to GEn dose. Efficacy data showed that a once-daily dose of GEn 600 to 2400 mg provides greater relief of RLS symptoms than placebo; GEn was generally well tolerated with an adverse event profile consistent with gabapentin.
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Clin Neuropharmacol · May 2012
Randomized Controlled Trial Multicenter StudyCombination treatment with aripiprazole and valproic acid for acute mania: an 8-week, single-blind, randomized controlled trial.
Despite the fact that combination treatment for patients with acute bipolar is prevalent in clinical practice, the outcomes of adjunct treatment with aripiprazole and a mood stabilizer have rarely been reported. The aim of this single-blind, randomized, controlled trial was to investigate treatment efficacy and safety of aripiprazole as an adjunct to valproic acid (Ari+Val), compared with haloperidol plus valproic acid (Hal+Val), in acute manic patients. ⋯ Our findings suggest that both combination strategies with Ari+Val and Hal+Val are beneficial for acute manic episode. Although patients receiving Ari+Val showed fewer extrapyramidal symptoms than those taking Hal+Val, careful consideration of adverse events such as weight gain and sedation is warranted.