SANCC: Clinical Trial Early Intervention

An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Subarachnoid Neurocysticercosis
• Intervention / Treatment: Drug: Albendazole

Detailed Description

PRIMARY OBJECTIVE:

I. To estimate the risk of serious adverse events (SAE) related to intervention in asymptomatic SANCC; these include drug-related side effects, moderate/severe intracranial hypertension, hydrocephalus requiring shunting or endoscopy, stroke, status epilepticus, or unexplained death.

OUTLINE:

Participants will be hospitalized for approximately 15-30 days while they receive treatment with the antiparasitic drug albendazole, as well as additional drugs (dexmathesaone and omeprazole) to address potential treatment complications. Participants will have continuous monitoring for adverse events while in the hospital. After participants are released to home, they will monitored for adverse events for an additional 12 months through home visits, telephone contact, and monthly clinical evaluations with serologic and radiologic assessment.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical intervention; Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.	Drug: Albendazole; Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety; all adverse events	Frequency and type of all adverse events	The 12 month period directly following the intervention
Diagnostic; antigen levels	Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect	Months 3,6,9, and 12 after intervention

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Seth E O'Neal, MD MPH, Oregon Health and Science University; Principal Investigator: Hector H Garcia, MD PhD, Universidad Peruana Cayetano Heredia

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: 00019627; 1R01NS103623-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized patient data for primary and secondary outcomes will be made available.
• IPD Sharing Time Frame: 6 months after trial completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the principal investigators. Requestors will be required to sign a Data Use Agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No