Randomized controlled trial of albendazole in new onset epilepsy and MRI confirmed solitary cerebral cysticercal lesion: Effect on long-term seizure outcome ☆ Aaron de Souza a , K. Thennarasu b , G. Yeshraj a , Jerry M.E. Kovoor c , A. Nalini a, ⁎ a Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, India b Department of Biostatistics, National Institute of Mental Health and Neurosciences, Bangalore, India c Departments of Neuroimaging and Interventional Radiology, National Institute of Mental Health and Neurosciences, Bangalore, India abstract article info Article history: Received 22 May 2008 Received in revised form 3 September 2008 Accepted 11 September 2008 Available online 11 October 2008 Keywords: Solitary cerebral cysticercal lesion Neurocysticercosis Long-term seizure outcome Magnetic resonance imaging No trials to date have focused on long-term seizure outcome in solitary cerebral cysticercal lesion (SCCL), which is believed to produce a relatively benign form of epilepsy. This is a prospective randomized controlled study to evaluate the effect of Albendazole on long-term seizure outcome in patients with MRI-confirmed solitary cerebral cysticercal lesion (SCCL). One hundred and twenty-three patients with new-onset seizures and SCCL on contrast MRI were randomized to treatment with albendazole and followed for up to five years with serial MRI and clinical evaluation. At final analysis 103 patients (M-54, F-49) with a mean age of 18.6 ±10.7 years and follow-up period more than 12 months were included. The mean follow-up duration was 31.4±14.8 months (12–64). At one month follow-up more patients receiving albendazole were seizure-free (62% versus 49% for controls). Subsequently there was no significant difference in overall seizure outcome between the two groups. There was no correlation between seizure semiology, albendazole therapy and long-term seizure outcome. Baseline MRI showed active lesions in all; 23% remained active at 12 months with no difference between the albendazole and control groups. Patients whose lesions resolved at 12 months showed better seizure outcome. Reduction in mean cyst area was greater in the albendazole group as compared to the controls and the difference at six months was significant (p b 0.05). At three months follow-up perilesional edema also resolved faster in albendazole group (p b 0.05). Thus, albendazole did not alter the long-term seizure outcome in patients with SCCL and epilepsy. However, albendazole hastened resolution of SCCL on MRI, but interestingly 23% of lesions were still active 12 months after treatment. © 2008 Elsevier B.V. All rights reserved. 1. Introduction Neurocysticercosis (NCC) is the most important cause of sympto- matic epilepsy in developing countries [1,2]. Active epilepsy has a prevalence of 2.2–49/1000 in various developing countries, in which the transitional phase of NCC is probably the most common cause of acute symptomatic seizures [3,4]. Thirty percent of adult epilepsy in Brazil, Ecuador and Togo and 8–35% of Indian epilepsy are linked to NCC [5–7]. Radiologic studies of Indian patients have shown NCC in 9– 24% of cases of chronic epilepsy [8–10]. Solitary cerebral cysticercal lesions (SCCL) are a common mani- festation of NCC in India and account for 60–71% of all cases of NCC and 50% of all patients with new-onset focal and generalised seizures [11,12]. SCCL are known to resolve or calcify within 6 months in 70– 85% of all patients [13]. Recurrence of seizures after resolution is ascribed to scar formation or to periodic inflammation around the calcific nodule [13,14]. There is controversy regarding the efficacy of praziquantel and albendazole therapy in hastening resolution of the cyst as well as their ultimate effect on seizure outcome. To resolve this issue, numerous trials to assess the efficacy of cysticidal drugs had been carried out in the last two decades, [11,15–28] but these did not definitively solve the issue. A few trials, largely in children, have focused on the efficacy of cysticidal drugs in SCCL [11,15,19,20,24–27]. No trials to date have examined the long-term seizure outcome in SCCL, which are believed to produce a relatively benign form of epilepsy, [2] and none have attempted a correlation between resolution of the cyst as visualised on serial MRI scans and seizure outcome. The present study is a randomised controlled trial of albendazole in patients with SCCL and new-onset seizures. We aim to describe the effect of this therapy on the clinical outcome i.e. long-term seizure recurrence after one year from seizure onset, and on the resolution of cysts on serial MRI. 2. Material and methods Patients were prospectively enrolled between May 2002 and October 2003 at the National Institute of Mental Health and Neurosciences. All Journal of the Neurological Sciences 276 (2009) 108–114 ☆ Funding: The present study was funded by Indian Council for Medical Research. Only the serial MRI scans were funded by the research council. No. SWG/Neuro/7/2001-NCD-I. ⁎ Corresponding author. Nalini Associate Professor of Neurology National Institute of Mental Health and Neurosciences Hosur Road Bangalore 560 029 India. Tel.: +91 80 26995139; fax: +91 80 26564830. E-mail addresses: atchayaramnalini@yahoo.co.in, nalini@nimhans.kar.nic.in (A. Nalini). 0022-510X/$ – see front matter © 2008 Elsevier B.V. All rights reserved. doi:10.1016/j.jns.2008.09.010 Contents lists available at ScienceDirect Journal of the Neurological Sciences journal homepage: www.elsevier.com/locate/jns