REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, NEW ORLEANS LA, APRIL 21-28, 2012 – The efficacy and safety of the oral fumarate BG-12 has been evaluated in the phase III studies DEFINE and CONFIRM (see BG-12 in RRMS: DEFINE trial, NeuroSens, October 21, 2011; CONFIRM – Second phase III trial results for BG-12, NeuroSens, November 30, 2011). New data from both trials were presented at AAN.
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Clobazam in Lennox-Gastaut syndrome: phase III results
August 29, 2012REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, NEW ORLEANS LA, APRIL 21-28, 2012 – The CONTAIN phase III trial evaluated the benzodiazepine derivative clobazam in patients with Lennox-Gastaut syndrome (LGS) (Ng et al. Neurology 2011;77:1473-1481). A total of 238 patients aged 2-60 years (mean 12.4 years) were randomized to one of three doses of clobazam (0.25, 0.5, 1.0 mg/kg/day) or placebo.
The trial consisted of a three-week titration phase and a 12-week maintenance phase. The average weekly seizure rate declined 41.2%, 49.4% and 68.3% with the three clobazam doses versus 12.1% with placebo (modified ITT analysis). Responder rates were 43.4%, 58.6% and 77.6% with clobazam versus 31.6% with placebo.
Medication problems when PD patients admitted to hospital
August 21, 2012REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, NEW ORLEANS LA, APRIL 21-28, 2012 – A Canadian study has found that 80% of PD patients admitted to hospital have their usual PD regimen changed or receive inappropriate medications (Wiltshire et al. AAN 2012; abstract S02.007).
What is the optimal dosing of natalizumab?
July 25, 2012REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, NEW ORLEANS LA, APRIL 21-28, 2012 – The initial dose-ranging study of natalizumab indicated that 1-3 mg/kg was clinically effective (Sheremata et al. Neurology 1999;52:1072-1074) and this was the dose selected by the Natalizumab MS Trial Group (O’Connor et al. Neurology 2004;62:2038-2043).
Higher doses of 3-6 mg/kg were used in phase II testing (Miller et al. N Engl J Med 2003;348:15-23; free full text at www.nejm.org/doi/pdf/10.1056/NEJMoa020696). Dosing by body weight was replaced by the one-size-fits-all 300 mg when natalizumab was initially approved in 2004 based on the dose used in the AFFIRM and SENTINEL phase III pivotal trials.