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SANCC: Clinical Trial Early Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950037
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
Universidad Peruana Cayetano Heredia
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Seth E O'Neal, MD MPH, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subarachnoid Neurocysticercosis Drug: Albendazole Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety; severe adverse events [ Time Frame: The 3 month period directly following the intervention ]
    Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention


Secondary Outcome Measures :
  1. Safety; all adverse events [ Time Frame: The 12 month period directly following the intervention ]
    Frequency and type of all adverse events

  2. Diagnostic; antigen levels [ Time Frame: Months 3,6,9, and 12 after intervention ]
    Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950037


Contacts
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Contact: Seth E O'Neal, MD MPH (504)494-0300 oneals@ohsu.edu
Contact: Hector H Garcia, MD PhD 511 328-7360 hgarcia@jhsph.edu

Sponsors and Collaborators
Oregon Health and Science University
Universidad Peruana Cayetano Heredia
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Seth E O'Neal, MD MPH Oregon Health and Science University
Principal Investigator: Hector H Garcia, MD PhD Universidad Peruana Cayetano Heredia
More Information
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Responsible Party: Seth E O'Neal, MD MPH, Assistant professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03950037    
Other Study ID Numbers: 00019627
1R01NS103623-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized patient data for primary and secondary outcomes will be made available.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurocysticercosis
Cysticercosis
Taeniasis
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Central Nervous System Infections
Infections
Parasitic Diseases
Cestode Infections
Helminthiasis
Central Nervous System Diseases
Nervous System Diseases
 Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents