ANTIPARASITIC THERAPY FOR NEUROCYSTICERCOSIS: PHASE II / III STUDY ON SAFETY AND EFFECTIVENESS AND COMBINED TREATMENT OF PRAZICUANTEL AND ALBENDAZOLE

Not Applicable

• Conditions: B690; -B690 Cysticercosis of central nervous system; Cysticercosis of central nervous system

• Registration Number: PER-121-06
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

1. Men and women between 16 and 65 years of age, with a diagnosis of viable cerebral parenchymal cysticercosis with 20 or fewer viable cysts detected by MRI and CT, and confirmed by Western Blot serology.
2. Patients with a diagnosis of epilepsy secondary to NCC and a history of one or more spontaneous seizures in the previous year and no more than 10 years.
3. Willingness to complete the minimum of two weeks of hospitalization required.
4. If the patient is a woman of childbearing age, negative urine tests and the willingness to use an adequate contraceptive method.
5. Normal values of hemoglobin, platelet count, white cell count, glucose and normal or decreased values of GOT, TGP, creatinine.
6. Negative PPD and, if positive, sputum results for TB, negative.
7. Negative stool test for Taenia eggs or Strongyloides larvae.

Exclusion Criteria

1. Generalized Primary Epilepsy.
2. History of generalized epileptic status.
3. Type of NCC that exposes the patient to greater risks during the study.
4. Patients with persistent or progressive endocranial hypertension (HTE) or intracranial hypertension defined radiologically by CT or MRI.
5. Previous therapy with ABZ or PZQ in the last two years.
6. Pulmonary tuberculosis evidenced by chest x-ray and positive results of sputum, or signs compatible with tuberculosis infection.
7. Individuals with positive markers for active hepatitis.
8. Systemic disease distinct from NCC that may affect treatment or short-term prognosis.
9. Patients with unstable condition.
10. Pregnancy during the antiparasitic treatment.
11. History of hypersensitivity to ABZ or PZQ.
12. Simultaneous treatment with cimetidine or theophylline.
13. Chronic alcohol or drug abuse.
14. Inability or non-availability to perform a CT scan at the beginning of the study or an MRI at the sixth month.
15. Inability or non-availability of the subject or agent / legal representative in giving written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Cerebral nuclear magnetic resonance (NMR), with contrast.<br>Measure:Proportion of parasites dying after a course with antiparasitic therapy.<br>Timepoints:6 months after starting therapy.<br>