Clinical neuropharmacology
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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 · Jul 2013
Review Case ReportsNeuroleptic malignant syndrome induced by lamotrigine.
This case report describes a 54-year-old man with bipolar I disorder who was treated with aripiprazole (ARP) and lithium. The patient was admitted to our hospital because of aggravation of depressive symptoms, and treatment with lamotrigine (LTG) was initiated. Two weeks after admission, we discontinued administration of ARP after the appearance of a tremor. ⋯ We suspected these symptoms were consistent with neuroleptic malignant syndrome and therefore removed the application of LTG. After 2 days, most of the patient's symptoms and blood results had improved, leading us to conclude that the LTG treatment had induced neuroleptic malignant syndrome. Thus, the purpose of this case report was to warn psychiatrists against therapy with LTG, as it may be conducive to neuroleptic malignant syndrome.
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Clin Neuropharmacol · Mar 2013
Review Case ReportsLong-acting injectable antipsychotics and the development of postinjection delirium/sedation syndrome (PDSS).
Five long-acting injectable (LAI) antipsychotics are currently available in the United States for the treatment of schizophrenia: fluphenazine decanoate, haloperidol decanoate, risperidone microspheres, paliperidone palmitate, and olanzapine pamoate. Additionally, aripiprazole LAI is currently under FDA review. However, research into the safety and tolerability of these LAIs, with particular regard to the development of postinjection delirium/sedation syndrome (PDSS), is limited and has been focused mainly on olanzapine pamoate. This proposal seeks to review data regarding all currently available LAI antipsychotics to determine if a significant association exists between these depot formulations and the development of PDSS. ⋯ Postinjection delirium/sedation syndrome is a potentially serious adverse event that has been shown to be associated with one currently available LAI antipsychotic, olanzapine pamoate. However, further data are still needed to both support this conclusion and determine if an association exists among other currently available LAIs and PDSS. With the bulk of current evidence coming from registration studies, head-to-head comparison studies between 2 LAIs would help to determine whether the risk of postinjection complications differs among different agents. Further observational studies are also needed to address the incidence, severity, and optimal clinical management of this syndrome.
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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.