Subarachnoid NeurocysticercosisPhase 2NCT03950037
SANCC: Clinical Trial Early Intervention
A Phase 2 study testing Albendazole in people with Subarachnoid Neurocysticercosis, run by Oregon Health and Science University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Subarachnoid Neurocysticercosis
- What is being tested?
- Albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Subarachnoid Neurocysticercosis
- Being tested
- Albendazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| Medical intervention | Experimental | Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole. Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety; severe adverse events
Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention
Measured: The 3 month period directly following the intervention
Secondary outcomes (2)
Safety; all adverse events
Frequency and type of all adverse events
Measured: 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
Measured: Months 3,6,9, and 12 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jan 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Unable to complete due to SARS-CoV-2 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid NeurocysticercosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Seth E O'Neal, MD MPH, Oregon Health and Science University
- Investigators
- Seth E O'Neal, MD MPH, Principal investigator, Oregon Health and Science UniversityHector H Garcia, MD PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950037
- Sponsor's protocol ID
- 00019627
- Other IDs
- 1R01NS103623-01A1
- Status last verified
- Apr 2022
- First submitted
- 13 May 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized patient data for primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
- ClinicalTrials.gov ID
- NCT03950037
- Acronym / sponsor ID
- 00019627
- Conditions
- Subarachnoid Neurocysticercosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to complete due to SARS-CoV-2 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical intervention | Experimental | Drug: AlbendazoleParticipants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlbendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d. | Drug | Medical intervention |
Primary outcome
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
2 secondary outcomes
Safety; all adverse events
Time frame: The 12 month period directly following the intervention
Diagnostic; antigen levels
Time frame: Months 3,6,9, and 12 after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Yes. Anonymized patient data for primary and secondary outcomes will be made available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth E O'Neal, MD MPH principal investigator
Oregon Health and Science University
Hector H Garcia, MD PhD principal investigator
Universidad Peruana Cayetano Heredia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albendazole in people with Subarachnoid Neurocysticercosis, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety; severe adverse events (time frame: The 3 month period directly following the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.