Status:
COMPLETED
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)
Lead Sponsor:
Universidad Peruana Cayetano Heredia
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Neurocysticercosis
Epilepsy
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
PHASE3
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 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. A...
Eligibility Criteria
Inclusion
- For parent study:
- Male or female individuals between 16 to 65 years of age, with a diagnosis of Neurocysticercosis and 20 or less viable cysts.
- Patients with a diagnosis of epilepsy secondary to Neurocysticercosis and a history of one or more spontaneous seizures within the previous year but not longer than 10 years.
- Willingness to complete a minimum of two weeks of hospitalization.
- If female of child bearing potential, negative urine pregnancy testing and willingness to use an adequate method of contraception while on study medications and for at least 3 months following Albendazole therapy.
- Normal laboratory values for hematocrit, platelets, white blood cells and glucose and normal or decreased values for Alanine transaminase, Aspartate transaminase and creatinine.
- Negative PPD measurement and if positive ( \> 9mm induration in the absence of other findings or immunosuppression ) , negative smears for TB.
- Negative fecal exam for Taenia eggs or Strongyloides larvae.
Exclusion
- Primary generalized seizures ( e.g., not caused by Neurocysticercosis )
- A history of generalized epileptic status .
- A type of Neurocysticercosis which can expose the patient to increased risk during the study.
- Patients with persistent or progressive symptomatic intracranial hypertension or intracranial hypertension.
- Previous therapy with Albendazole or Praziquantel in the previous year.
- Pulmonary tuberculosis, or symptoms compatible with tuberculosis not otherwise explained.
- Active hepatitis
- Systemic disease that may affect short term prognosis.
- Patients in unstable condition ( consistently abnormal vital signs: body temperature, heart rate, respiratory rate, and blood pressure )
- Pregnancy during antiparasitic treatment
- History of hypersensitivity to Albendazole or Praziquantel
- Concurrent treatment with Cimetidine or Theophylline
- Chronic alcohol or drug abuse
- Unwilling or unable to provide a Computed tomography initially or an Magnetic resonance imaging at 6 months ( as patients with ferromagnetic implants ) , Computed tomography at the end of therapy.
- Unwillingness of subject or legal representative to give written informed consent.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00441285
Start Date
January 1 2010
End Date
September 1 2013
Last Update
June 11 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Nacional Edgardo Rebagliati
Lima, Lima Province, Peru, Lima 11
2
Hospital Nacional Cayetano Heredia
Lima, Lima Province, Peru, Lima 31
3
Hospital Nacional Guillermo Almenara
Lima, Lima Province, Peru, Lima 5
4
Instituto Nacional de Ciencias Neurologicas
Lima, Peru