Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
Condition: Neurocysticercosis; Epilepsy
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis; Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if combination drug therapy of praziquantel and
      albendazole is safe and effective to cure neurocysticercosis.
    

Detailed description: 
      Neurocysticercosis is the single major cause of acquired or late-onset epilepsy in the world,
      and a common diagnosis in immigrant populations in the United States and other industrialized
      countries. An estimated 50 million humans are affected by Neurocysticercosis. The disease
      occurs when a parasite called Taenia solium, or the pig tapeworm, infects the brain, forming
      cysts. Neurocysticercosis is generally treated with 1 of 2 drugs, praziquantel or
      albendazole. However, current treatment with either of these drugs alone is not totally
      effective.

      The goal of this trial is to determine if combination drug therapy of praziquantel and
      albendazole is safe and more effective to cure Neurocysticercosis than either drug
      administered alone. This trial will consist of two sub-studies and a parent study.

      In the first substudy which was performed and completed as the initial part and guide to the
      design of the parent study, a series of 32 patients with viable cystic intraparenchymal
      Neurocysticercosis were treated with either albendazole ( 15 mg / kg /d ) + praziquantel ( 50
      mg / kg/ d ) or albendazole+Placebo in a double blind randomized study. Half of patients in
      each group had their seizure disorder treated with phenytoin and the other half with
      carbamazepine (not assigned by the study). The study was designed and powered for
      pharmacokinetic evaluation and exploratory safety so comparative cysticidal efficacy has not
      yet been analyzed. There were no safety concerns. Pharmacokinetics of ABZ and PZQ were
      obtained and described.

      In the parent study, a total of 240 participants ( including the 32 participants from the
      first substudy ) will be randomly chosen to receive albendazole + praziquantel, albendazole +
      placebo or albendazole at an increased dose + placebo for 10 days. These groups will also
      receive other standard medications to manage the disease including appropriate anti-epileptic
      drug therapy. Participants will stay in the hospital for at least 2 weeks after treatment
      begins, which includes 5 days after the end of anti-parasitic treatment. After discharge from
      the hospital, follow-up visits will be on days 21 and 30 after treatment begins, then monthly
      until day 90, and finally every 3 months until completing 18 months. Brain images will be
      taken at 6 and 12 months after treatment begins. For participants, duration of the trial is 1
      year and a half.
    

Intervention name(s): Praziquantel; Albendazole; ABZ Placebo; PZQ Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): - Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.; Albendazole 15 mg / kg / d ( up to 800 mg /d ) in Arm I for 10 days.
Albendazole at an increased dose, 22.5 mg / kg / d (up to 1200 mg / d ), in Arm II for 10 days.; - Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.; - Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
Other intervention name(s): PZQ; ABZ; Placebo of Albendazole; Placebo of PZQ
Intervention MeSH terms: Albendazole; Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurocysticercosis; NCC; praziquantel; PZQ; albendazole; ABZ; parasite; pig tapeworm; Taenia solium; epilepsy; late-onset epilepsy; acquired epilepsy