SANCC: Clinical Trial Early Intervention

NCT03950037 | Withdrawn Phase 2 DMC

• 2 other identifiers: 000196271R01NS103623-01A1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subarachnoid neurocysticercosis (SANCC) is a severe infection of the brain by the tapeworm Taenia solium. People who have this infection are usually diagnosed late in the disease process leading to very poor prognosis. This trial studies the safety of early medical intervention in people who have SANCC but do not have symptoms. The trial will enroll 18 participants in Peru.

Conditions

Subarachnoid Neurocysticercosis

Outcome Measures

Primary Outcomes (1)

• Safety; severe adverse events

  Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention

  The 3 month period directly following the intervention

Secondary Outcomes (2)

• Safety; all adverse events

  The 12 month period directly following the intervention

• Diagnostic; antigen levels

  Months 3,6,9, and 12 after intervention

Study Arms (1)

Medical intervention

EXPERIMENTAL

Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.

Drug: Albendazole

Interventions

Albendazole DRUG

Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.

Medical intervention

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female individuals older than two years with a diagnosis of asymptomatic SANCC confirmed by MRI.
• SANCC limited to the basal cisterns, the interhemispheric brain space, brain fissures or spine.
• Baseline laboratory results within acceptable ranges (specifically defined in the study protocol)
• Willingness to accomplish the two-week minimum hospitalization required.

You may not qualify if:

• Individuals who only have subarachnoid lesions in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions
• Co-occurrence of a) more than 20 intraparenchymal lesions in addition to their subarachnoid disease, or b) intraparenchymal lesions greater than 3.0 cm of diameter
• Individuals for whom a surgical intervention to treat their subarachnoid disease is considered clearly superior to a medical intervention
• Previously diagnosis or treatment for cysticercosis.
• Active pulmonary tuberculosis evidenced by 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
• Other systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, or steroid-dependent immune diseases
• Pregnancy. If a participant becomes pregnant during the study, she will continue in the study but will have radiological exams delayed until after delivery
• History of hypersensitivity to ABZ
• Chronic alcohol or drug abuse as defined in the study protocol
• Unwilling or unable to provide MRI exams (e.g. patients with ferromagnetic implants)
• Inability or unwillingness of subject or legal representative to give written informed consent.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Universidad Peruana Cayetano Heredia: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

MeSH Terms

Interventions

Albendazole

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seth E O'Neal, MD MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Hector H Garcia, MD PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: January 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after trial completion
• Access Criteria: Data access requests will be reviewed by the principal investigators. Requestors will be required to sign a Data Use Agreement.