Clinical Trial: Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Antiparasitic Therapy for Neurocysticercosis: Phase II/III Study on Safety and Efficacy of Combined Treatment With Praziquantel and Albendazole

Brief 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 Summary:

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 grou
Sponsor: Universidad Peruana Cayetano Heredia

Current Primary Outcome:

  • PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1 [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1 ]
    - To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
  • PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11 [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11 ]
    - To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).
  • PK Substudy - Maximum Concentration of Albendazole [ Time Frame: Treatment day 1 and Treatment days 10-11 ]
    Highest serum level of Albendazole measured from all level assessments in the curve.
  • Phase III Trial - Proportion of Patients Without Remaining Live Cysts [ Time Frame: Day 180 ]
    Proportion of patients whose 6 month MR does not show viable parasites anymore


Original Primary Outcome: The primary study endpoint is the proportion of parasites that die after one course of antiparasitic therapy (evaluated by contrast-enhanced MRI 6 months after therapy onset) in patients receiving combined ABZ+PZQ therapy compared to ABZ only.

Current Secondary Outcome:

  • PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1 [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1 ]
    - To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
  • PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11 [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11 ]
    - To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin
  • PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy [ Time Frame: 90 days post tx ]
    - Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.
  • Phase III Trial - Proportion of Cysts Which Resolved [ Time Frame: Day 180 ]
    Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI
  • Phase III Trial - Seizure Frequency [ Time Frame: Day 1 - 540 ]
    Seizure frequency by treatment group


Original Secondary Outcome:

Information By: Universidad Peruana Cayetano Heredia

Dates:
Date Received: February 27, 2007
Date Started: January 2010
Date Completion:
Last Updated: May 15, 2015
Last Verified: May 2015