Abstract
Background
Aprepitant is a neurokinin-1 receptor antagonist (NK1R)
approved for the treatment of chemotherapy-induced nausea. We aimed to
investigate the safety and efficacy of aprepitant in patients with subacute
sclerosing panencephalitis (SSPE).
Methods
A randomized, double-blind, placebo-controlled study was
conducted in patients with SSPE assigned to receive two courses of aprepitant
250 mg/day p.o. or placebo for 15 days with an interval of 2 months between
courses. Primary endpoints were safety and tolerability and secondary endpoint,
clinical improvement/stabilization assessed by SSPE Scoring System.
Electroencephalography (EEG), brain magnetic resonance imaging (MRI) and
cerebrospinal fluid measles-specific IgG index were evaluated before and after
treatment.
Results
Sixty-two SSPE patients were allocated to aprepitant (n=31,
median age 18 years) or placebo (n=31, median age 22 years) groups. Fifteen
patients left the study within the first 6 months and 12 patients left between
6-12 months. Aprepitant was well tolerated and treatment–associated adverse
events were similar to those described in the treatment of nausea. Clinical
status at 6 and 12 months follow-up did not differ between aprepitant and
placebo groups. Post-treatment EEG scores at 12 months were better in the
aprepitant group (p=0.015). Cerebral atrophy on MRI increased in both groups
while measles-specific IgG index decreased in the placebo group.
Conclusion
In this first clinical trial of aprepitant treatment in SSPE
patients, the drug was safe and well tolerated. No clinical effect was
observed. A modest improvement in EEG findings might justify trials for longer
periods because EEG changes can precede clinical findings in SSPE.
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