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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if combination drug therapy of praziquantel and albendazole is safe and effective to cure neurocysticercosis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Peruana Cayetano Heredia
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Albendazole; Praziquantel

Criteria

For parent study:

Inclusion Criteria:

• 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 Criteria:

• 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.