Trial intelligence / Profile preview

Albendazole for Neurocysticercosis

NCT00283699Phase 3

Key facts

Status
Completed
Start
Feb 2001
Primary completion
Feb 2005
Countries
1
Sponsor
Columbia University
Modality
Small Molecules
Conditions
neurocysticercosis (NCC)
01

Overview

Phase 3, randomised, double-blind trial in neurocysticercosis (NCC) comparing Albendazole + Symptomatic Therapy with Placebo + Symptomatic Therapy (2 arms). Primary endpoint: Cyst freedom at 1 year. Started Feb 2001; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Albendazole + Symptomatic Therapy

    Albendazole (15 mg/kg/day or 800 mg) + prednisolone + standard symptomatic therapy

  • Placebo + Symptomatic Therapy

    Placebo + prednisolone + standard symptomatic therapy

03

Who it enrols

Patients with new-onset neurocysticercosis symptoms within 2 months and active/transitional cysts on imaging. Excludes pregnant patients, those with only calcifications, specific concurrent conditions (papilledema, active tuberculosis, syphilis, ocular cysticercosis, active gastric ulcers), and recent use of anthelmintic drugs or steroids.

04

Endpoints

Primary

  • Cyst freedom

Secondary

  • Cyst reduction

  • Seizure freedom

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