NeurocysticercosisPhase 3SANTONCT02947581
Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)
A Phase 3 study testing Albendazole and praziquantel in people with Neurocysticercosis, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
Trial summary
Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological disease in most of the world. When parasites locate in the cavities around the brain (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal presentation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurocysticercosis
- What is being tested?
- Albendazole and praziquantel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesPeru
- Study dates
- 14 Nov 2016to 27 Feb 2021
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal subarachnoid cysticercosis (including locations in the Sylvian fissure or lower interhemispheric spaces) by neuroimaging and confirmed by serology.
- Baseline laboratory results along acceptable ranges (specifically defined in the study protocol).
- Willingness to accomplish the two-week minimum hospitalization required.
Who cannot join
- Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who received single-dose ABZ for intestinal parasites, or patients who received antiparasitic treatment between one and three years before enrollment but demonstrated lesion persistence or progression during the past 12 months).
- A type of NCC which can expose the patient to increased risk during the study, specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2 cm in diameter, without hydrocephalus or intracranial hypertension, can be included. The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will not exclude the patient unless there are more than 20 of them.
- Active pulmonary tuberculosis evidenced by positive 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.
- Systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
- Patients in unstable condition or with symptomatic intracranial hypertension (ICH). Definition of symptomatic ICH for this study is the presence of headaches, nausea, and vomiting, with papilledema at fundoscopic examination. Patients in this category can be considered for entrance into the study only after resolution of ICH by ventricular-peritoneal shunting or neuroendoscopic procedures involving CSF flow derivation. These procedures would be done as part of their standard medical care and are not part of the trial intervention.
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- Pregnancy during anti-parasitic treatment. If a patient becomes pregnant after treatment, she will continue in the study but will have radiological exams delayed until after delivery.
- History of hypersensitivity to ABZ or PZQ
- Chronic or drug abuse as defined in the study protocol.
- Unwilling or unable to undergo MRI exams (like patients with ferromagnetic implants)
- Inability or unwillingness of subject or legal representative to give written informed consent.
Trial locations and contacts
2 sites in 1 country.
Peru2 sites
Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
Lima, Lima 1
Hospital Nacional Cayetano Heredia
Lima
About this study
Official title: A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns
Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological disease in most of the world. When parasites locate in the cavities around the brain (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal presentation. Current treatment regimens for SANCC have quite limited efficacy. The investigators propose to compare the current standard of care (a single antiparasitic drug, albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador, and one in Brasil.
Read the detailed description
Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
In short, this is a parallel group study with a dichotomous primary outcome variable. The main analysis will compare the proportions of patients obtaining the primary outcome at 6 months, using a Chi-square test in a bivariate analysis. A similar analysis will be used for the proportions of patients with a good clinical outcome, and the proportions of patients in whom lesion resolution sustains when assessed at month 12. A Student T test analysis will be used to compare for reduction in parasite volume and non-parametric Mann-Whitney test will be alternatively applied for non-normally distributed data. A non-parametric Spearman's Rho test will be used to assess the correlation between the proportions of cyst mass reduction with the decrease in antigen levels in each study group. A Chi-square test in a bivariate analysis will evaluate the association between negative antigen levels at 6 months versus the complete disappearance of cyst mass.
- Conditions
- Neurocysticercosis
- Being tested
- Albendazole and praziquantel, Albendazole and praziquantel placebo
- Keywords
- subarachnoid neurocysticercosis, albendazole, praziquantel
- Medical subject headings
- Neurocysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole and praziquantelDrug
Also called ABZ+PZQ
Intervention - PZQ (50 mg/k/d, up to 3600 mg/d, for 15 days), as an add-on to ABZ treatment (15 mg/k/d, up to 800 mg/d for days 1-20, up to 1200 mg/d for days 21-30). In order to maintain the double blind nature of the trial, ABZ placebo will be administered to individuals over 53 kg of weight until completing the equivalent doses in the comparison group.
Albendazole and praziquantel placeboDrug
Also called ABZ+PZQ PCB
PZQ placebo in similar doses, given during the initial 15 days of ABZ treatment at standard doses (15 mg/k/d up to 1200 mg/d for 30 days)
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Experimental | Albendazole and praziquantel. Albendazole: 15 mg/k/d up to 800 mg/d (days 1 to 20), followed by 15 mg/k/d up to 1200 mg/d (day 21 to 30) and prazicuantel (50 mg/k/d days 1 to 15). Receives: Drug: Albendazole and praziquantel |
| Comparison regime | Active comparator | Albendazole and praziquantel placebo. Albendazole: 15 mg/k/d (days 1 to 30) and prazicuantel placebo in similar doses 50 mg/k/d (days 1 to 15). Receives: Drug: Albendazole and praziquantel placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological efficacy at three months (3-month improvement).
Thirty percent or greater decrease in the combined volume of all parasitic masses, evaluated by contrast-enhanced MRI 3 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification.
Measured: Day 90 +/- 15 days
Secondary outcomes (4)
Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3).
Total disappearance or greater than 50% decrease in the combined volume of subarachnoid parasites, evaluated by contrast-enhanced MRI 6 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification. three.months after treatment onset (comparative between treatment arms).
Measured: Day 180 +/- 15 days
Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6)
No reappearance or re-growth of the parasitic lesions on contrast enhanced MRI at 12 months after therapy onset, recorded as a dichotomous outcome. hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist 12 months post treatment.
Measured: Day 365 +/- 15 days
Clinically asymptomatic patient
No evidence of uncontrolled seizures, chronic severe headaches, intracranial hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist at 3, 6, and 12 months post treatment.
Measured: 3, 6, and 12 months
Decrease in serum levels
will be measured at 3 months, and expressed as a proportion of the baseline level. This variable will be compared between arms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start14 Nov 2016
- Primary completion21 Aug 2020
- Study completion27 Feb 2021
Why it stopped: Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector H. Garcia Lescano, Ph.D, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947581
- Sponsor's protocol ID
- 61449
- Acronym
- SANTO
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2016
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized patient data will be shared upon request and review by the project leaders.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns
- ClinicalTrials.gov ID
- NCT02947581
- Acronym / sponsor ID
- SANTO / 61449
- Conditions
- Neurocysticercosis
- Keywords
- subarachnoid neurocysticercosis, albendazole, praziquantel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological disease in most of the world. When parasites locate in the cavities around the brain (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal presentation. Current treatment regimens for SANCC have quite limited efficacy. The investigators propose to compare the current standard of care (a single antiparasitic drug, albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador, and one in Brasil.
Detailed description
Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
In short, this is a parallel group study with a dichotomous primary outcome variable. The main analysis will compare the proportions of patients obtaining the primary outcome at 6 months, using a Chi-square test in a bivariate analysis. A similar analysis will be used for the proportions of patients with a good clinical outcome, and the proportions of patients in whom lesion resolution sustains when assessed at month 12. A Student T test analysis will be used to compare for reduction in parasite volume and non-parametric Mann-Whitney test will be alternatively applied for non-normally distributed data. A non-parametric Spearman's Rho test will be used to assess the correlation between the proportions of cyst mass reduction with the decrease in antigen levels in each study group. A Chi-square test in a bivariate analysis will evaluate the association between negative antigen levels at 6 months versus the complete disappearance of cyst mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.
| Arm | Type | Receives |
|---|---|---|
| Interventions | Experimental | Drug: Albendazole and praziquantelAlbendazole and praziquantel. Albendazole: 15 mg/k/d up to 800 mg/d (days 1 to 20), followed by 15 mg/k/d up to 1200 mg/d (day 21 to 30) and prazicuantel (50 mg/k/d days 1 to 15). |
| Comparison regime | Active comparator | Drug: Albendazole and praziquantel placeboAlbendazole and praziquantel placebo. Albendazole: 15 mg/k/d (days 1 to 30) and prazicuantel placebo in similar doses 50 mg/k/d (days 1 to 15). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal subarachnoid cysticercosis (including locations in the Sylvian fissure or lower interhemispheric spaces) by neuroimaging and confirmed by serology.
- Baseline laboratory results along acceptable ranges (specifically defined in the study protocol).
- Willingness to accomplish the two-week minimum hospitalization required.
Key exclusion criteria (11 listed)
- Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who received single-dose ABZ for intestinal parasites, or patients who received antiparasitic treatment between one and three years before enrollment but demonstrated lesion persistence or progression during the past 12 months).
- A type of NCC which can expose the patient to increased risk during the study, specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2 cm in diameter, without hydrocephalus or intracranial hypertension, can be included. The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will not exclude the patient unless there are more than 20 of them.
- Active pulmonary tuberculosis evidenced by positive 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.
- Systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
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 |
|---|---|---|
| Albendazole and praziquantelAlso: ABZ+PZQIntervention - PZQ (50 mg/k/d, up to 3600 mg/d, for 15 days), as an add-on to ABZ treatment (15 mg/k/d, up to 800 mg/d for days 1-20, up to 1200 mg/d for days 21-30). In order to maintain the double blind nature of the trial, ABZ placebo will be administered to individuals over 53 kg of weight until completing the equivalent doses in the comparison group. | Drug | Interventions |
| Albendazole and praziquantel placeboAlso: ABZ+PZQ PCBPZQ placebo in similar doses, given during the initial 15 days of ABZ treatment at standard doses (15 mg/k/d up to 1200 mg/d for 30 days) | Drug | Comparison regime |
Primary outcome
Radiological efficacy at three months (3-month improvement).
Time frame: Day 90 +/- 15 days
Thirty percent or greater decrease in the combined volume of all parasitic masses, evaluated by contrast-enhanced MRI 3 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification.
4 secondary outcomes
Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3).
Time frame: Day 180 +/- 15 days
Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6)
Time frame: Day 365 +/- 15 days
Clinically asymptomatic patient
Time frame: 3, 6, and 12 months
Decrease in serum levels
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Yes. Anonymized patient data will be shared upon request and review by the project leaders.
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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.
Hector H. Garcia Lescano, Ph.D principal investigator
Universidad Peruana Cayetano Heredia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole and praziquantel in people with Neurocysticercosis, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.). Results are not available in the source record.
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?
Radiological efficacy at three months (3-month improvement). (time frame: Day 90 +/- 15 days). 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 16 Nov 2022.