Subarachnoid Neurocysticercosis Clinical Trial
Official title:
An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
| Verified date | April 2022 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2023 |
| Est. primary completion date | April 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS), Universidad Peruana Cayetano Heredia |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Safety; all adverse events | Frequency and type of all adverse events | The 12 month period directly following the intervention | |
| Secondary | 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 |