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SANCC: Clinical Trial Early Intervention

Primary Purpose

Subarachnoid Neurocysticercosis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Albendazole

About this trial

This is an interventional treatment trial for Subarachnoid Neurocysticercosis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medical intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Safety; severe adverse events

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

Secondary Outcome Measures

Safety; all adverse events

Frequency and type of all adverse events

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

Full Information

NCT ID

NCT03950037

First Posted

May 13, 2019

Last Updated

April 4, 2022

Sponsor

Oregon Health and Science University

Collaborators

Universidad Peruana Cayetano Heredia, National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT03950037

Brief Title

SANCC: Clinical Trial Early Intervention

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to complete due to SARS-CoV-2 pandemic

Study Start Date

January 1, 2022 (Anticipated)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

Universidad Peruana Cayetano Heredia, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Neurocysticercosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medical intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Albendazole

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety; severe adverse events

Description

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

Time Frame

The 3 month period directly following the intervention

Secondary Outcome Measure Information:

Title

Safety; all adverse events

Description

Frequency and type of all adverse events

Time Frame

The 12 month period directly following the intervention

Title

Diagnostic; antigen levels

Description

Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect

Time Frame

Months 3,6,9, and 12 after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seth E O'Neal, MD MPH

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hector H Garcia, MD PhD

Organizational Affiliation

Universidad Peruana Cayetano Heredia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

SANCC: Clinical Trial Early Intervention

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