Neurocysticercosis: Combined Treatment With Praziquantel and Albendazole

• Maximum plasma concentration (Cmax) and area under the curve (AUC), for ABZSO4 and PZQ [ Time Frame: Treatment days 1 to 10 ] [ Designated as safety issue: Yes ]
  

• Difference in plasma levels of ABZ between patients in the ABZ+PCB group compared to those in the ABZ+PZQ group. [ Time Frame: Treament days 1 to 10 ] [ Designated as safety issue: Yes ]
  
• effects of phenytoin and carbamazepine in PZQ levels when given in addition to ABZ, dexamethasone, and ranitidine. [ Time Frame: Treatment days 1 to 10 ] [ Designated as safety issue: Yes ]
  
• safety of the combination ABZ+PZQ compared to ABZ alone [ Time Frame: Days 1 to 90 ] [ Designated as safety issue: Yes ]
  

Neurocysticercosis (NCC) 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 NCC. The disease occurs when a parasite called Taenia solium, or the pig tapeworm, infects the brain, forming cysts. NCC is generally treated with 1 of 2 drugs, praziquantel (PZQ) or albendazole (ABZ). 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 PZQ and ABZ is safe and more effective to cure NCC than either drug administered alone. This trial will consist of both a sub-study and a parent study.

In the sub-study—which will be performed as the initial part and guide to the design of the parent study—32 participants will be randomly chosen to receive either ABZ and PZQ or ABZ and placebo (an inactive substance) for 10 days. Both groups will also receive other standard medications to manage the disease. Participants will stay in the hospital for at least 2 weeks after treatment begins. After discharge from the hospital, participants will have follow-up visits. During one of the visits, participants will provide an additional blood sample for safety testing. Participants will be followed for 3 months. The purpose of this sub-study is to evaluate the safety and pharmacokinetics of ABZ and PZQ. Enrollment for the sub-study is now complete. Enrollment for the parent study has not yet begun.

In the parent study, a total of 180 participants (including the 32 participants from the sub-study) will be randomly chosen to receive either ABZ and PZQ or ABZ and placebo for 10 days. Both 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 22 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.