Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
NCT00441285 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2015-06-11
Summary
The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.
Conditions
- Neurocysticercosis
- Epilepsy
Interventions
- DRUG
-
Praziquantel
\- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.
- DRUG
-
Albendazole
* 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.
- DRUG
-
ABZ Placebo
\- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.
- DRUG
-
PZQ Placebo
\- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH -
Universidad Peruana Cayetano Heredia
lead OTHER
Principal Investigators
-
Hector H. Garcia, MD · Universidad Peruana Cayetano Heredia
-
E. Javier Pretell, MD · Hospital Alberto
-
Javier A. Bustos, MD · Universidad Peruana Cayetano Heredia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-09-30
Countries
- Peru
Study Locations
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