Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2022
• Main ID: NCT02947581
• Date of registration: 24/10/2016
• Prospective Registration: Yes
• Primary sponsor: Universidad Peruana Cayetano Heredia
• Public title: Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO) SANTO
• Scientific title: A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns
• Date of first enrolment: November 14, 2016
• Target sample size: 107
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02947581
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Peru

Contacts

• Name: Hector H. Garcia Lescano, Ph.D
• Affiliation: Universidad Peruana Cayetano Heredia

Key inclusion & exclusion criteria

Inclusion Criteria:

- - Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal
subarachnoid cysticercosis (including locations in the Sylvian fissure or lower
interhemispheric spaces) by neuroimaging and confirmed by serology.

- Baseline laboratory results along acceptable ranges (specifically defined in the study
protocol).

- Willingness to accomplish the two-week minimum hospitalization required.

Exclusion Criteria:

- Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who
received single-dose ABZ for intestinal parasites, or patients who received
antiparasitic treatment between one and three years before enrollment but demonstrated
lesion persistence or progression during the past 12 months).

- A type of NCC which can expose the patient to increased risk during the study,
specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant
intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC
lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or
d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2
cm in diameter, without hydrocephalus or intracranial hypertension, can be included.
The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will
not exclude the patient unless there are more than 20 of them.

- Active pulmonary tuberculosis evidenced by positive chest X-ray and positive sputum
smears, or symptoms compatible with tuberculosis (fever+sweats or fever+cough) not
otherwise explained.

- Individuals with positive markers for active hepatitis.

- Systemic disease that may affect therapy or short-term prognosis, including but not
limited to chronic renal failure, hepatic insufficiency, cardiac failure, and
steroid-dependent immune diseases.

- Patients in unstable condition or with symptomatic intracranial hypertension (ICH).
Definition of symptomatic ICH for this study is the presence of headaches, nausea, and
vomiting, with papilledema at fundoscopic examination. Patients in this category can
be considered for entrance into the study only after resolution of ICH by
ventricular-peritoneal shunting or neuroendoscopic procedures involving CSF flow
derivation. These procedures would be done as part of their standard medical care and
are not part of the trial intervention.

- Pregnancy during anti-parasitic treatment. If a patient becomes pregnant after
treatment, she will continue in the study but will have radiological exams delayed
until after delivery.

- History of hypersensitivity to ABZ or PZQ

- Chronic or drug abuse as defined in the study protocol.

- Unwilling or unable to undergo MRI exams (like patients with ferromagnetic implants)

- Inability or unwillingness of subject or legal representative to give written informed
consent.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neurocysticercosis

Intervention(s)

Drug: Albendazole and praziquantel placebo

Drug: Albendazole and praziquantel

Primary Outcome(s)

Radiological efficacy at three months (3-month improvement). [Time Frame: Day 90 +/- 15 days]

Secondary Outcome(s)

Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) [Time Frame: Day 365 +/- 15 days]

Clinically asymptomatic patient [Time Frame: 3, 6, and 12 months]

Decrease in serum levels [Time Frame: 3 months]

Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3). [Time Frame: Day 180 +/- 15 days]

Secondary ID(s)

61449

Source(s) of Monetary Support

Please refer to primary and secondary sponsors