A Phase 2 interventional study of Albendazole in Subarachnoid Neurocysticercosis, sponsored by Oregon Health and Science University. Withdrawn. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment
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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.
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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
Browse Neurocysticercosis studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Safety; severe adverse events
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
Safety; all adverse events
Frequency and type of all adverse events
Time frame: 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
Time frame: Months 3,6,9, and 12 after intervention
No study locations are listed for this record.
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2022; primary completion for Apr 2023, 15 months later.
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This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albendazole
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