Epilepsy & behavior : E&B
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Epilepsy & behavior : E&B · May 2013
Randomized Controlled TrialClinical features associated with placebo response in refractory focal epilepsy.
For clinical trial design and for clinical practice, it is of importance to assess factors associated with placebo response in patients with refractory epilepsy. We determined factors associated with placebo response in 359 adult patients with refractory focal epilepsy participating in three randomized placebo-controlled trials of the new antiepileptic drug lacosamide. At the end of the randomized 12-week maintenance period, 81 (23%) of the 359 patients randomized to placebo achieved at least a 50% seizure reduction (responders) compared to baseline. ⋯ A history of 7 or more prior lifetime AEDs lowered the chance of achieving placebo response compared to 1-3 prior lifetime AEDs [p<0.001, OR 0.224 (95% CI: 0.101-0.493)] as did a baseline seizure frequency >10 seizures per 28 days compared to ≤5 seizures per 28 days [p=0.026, OR 0.431 (95% CI: 0.205-0.904)]. Prior epilepsy surgery lowered the likelihood of placebo response [p=0.02, OR 0.22 (95% CI: 0.062-0.785)]. We suggest that age at exposure to placebo, age at diagnosis of epilepsy, the number of prior lifetime AEDs, baseline seizure frequency and a history of epilepsy surgery appear to be associated with placebo response in adults with refractory focal epilepsy.
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Epilepsy & behavior : E&B · Dec 2012
Randomized Controlled TrialLong-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study.
In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2.0 mg/kg/day (≤80 mg/day). Of 306 eligible patients from OV-1002 or OV-1012, 267 entered the open-label extension. As of the interim date, July 1, 2010, 213 patients (79.8%) had remained in the trial, and 189 had received clobazam for ≥12 months, 128 for ≥18 months, and 94 for ≥24 months. ⋯ Mean modal and mean maximum daily dosages were 0.94 mg/kg and 1.22 mg/kg for those who had received clobazam for ≥1 year. The 4 most common adverse events were upper respiratory tract infection (18.4%), fall (14.2%), pneumonia (13.9%), and somnolence (12.7%). Clobazam's adverse event profile was consistent with its profile in controlled trials.
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Epilepsy & behavior : E&B · Apr 2012
Randomized Controlled TrialPregabalin increases slow-wave sleep and may improve attention in patients with partial epilepsy and insomnia.
Insomnia is a common phenomenon particularly in patients with epilepsy. This study was performed to look at the effects of pregabalin, an anticonvulsant known to increase sleep depth and decrease arousals, in patients with insomnia and well-controlled epilepsy. ⋯ Concurrent treatment with pregabalin improves sleep depth in patients with insomnia and epilepsy and improves daytime attention.
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Epilepsy & behavior : E&B · Aug 2011
Randomized Controlled TrialRandomized comparison of the Personality Assessment Inventory and the Minnesota Multiphasic Personality Inventory-2 in the epilepsy monitoring unit.
The two most common personality measures used in evaluation of patients on epilepsy monitoring units (EMUs) are the Personality Assessment Inventory (PAI) and the Minnesota Multiphasic Personality Inventory-2 (MMPI-2). Both have been evaluated separately for their ability to distinguish patients with epilepsy from patients with psychogenic events, but they have never been compared directly. ⋯ Results show that the PAI Somatic Complaints (SOM) scale and the Conversion subscale (SOM-C), with classification rates of 79%, outperform other indicators from the PAI and indicators from the MMPI-2 and the MMPI-2-RF. Given its other strengths combined with better diagnostic validity performance, the PAI may be the better personality assessment measure for use in distinguishing patients with epilepsy from those with psychogenic seizures in the EMU.
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Epilepsy & behavior : E&B · Oct 2009
Randomized Controlled Trial Comparative Study Clinical TrialLevetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques.
The safety profiles of once-daily adjunctive levetiracetam (LEV) extended release (XR) (1000mg/day) and adjunctive LEV immediate release (IR) (500mg twice daily) were compared using data from three randomized, placebo (PBO)-controlled phase III clinical trials in patients with partial-onset seizures. MedDRA 9.0 treatment-emergent adverse events (TEAEs) were indirectly compared using meta-analytic techniques, including calculation of risk difference (RD) and mixed-effects analysis. Statistical significance was set at 10% alpha risk, the normative value for these analyses. ⋯ Among nervous system disorders, the RD for headache favored LEV XR (RD=-11%, P=0.08). These results suggest that adjunctive LEV XR may be associated with a lower incidence of nervous system, psychiatric, and nutritional and metabolic TEAEs as compared with LEV IR. However, this difference was observed at a broad scale and not at a specific TEAE level except for headache.