Brain CysticercosisPhase 2/3NCT06565507
Oxfendazole in Mild Parenchymal Brain Cysticercosis
A Phase 2/3 study testing Oxfendazole single dose, Oxfendazole three doses and albendazole plus praziquantel regime in people with Brain Cysticercosis, run by Universidad Peruana Cayetano Heredia.
Trial summary
The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Cysticercosis
- What is being tested?
- Oxfendazole single dose, Oxfendazole three doses and albendazole plus praziquantel regime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 15 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female individuals between 18 and 75 years of age, with suspected viable or degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and Chandy, 1997)
- If female of child-bearing potential and men, willing to use an adequate method of contraception*, including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.
- Patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, ALT, and AST.
- Availability to grant informed consent.
Who cannot join
- Multiple lesion sites or more than two adjacent lesions.
- Suspected neurotuberculosis (Rajshekhar's criteria) [66,67]
- More than two viable brain cysts.
- Large brain cysts (> 3cm in diameter)
- Subarachnoid neurocysticercosis or intraventricular
- Untreated ocular cysticercosis
Show all 16Show fewer
- Previous therapy with ABZ (does not include patients who received single-dose 400 mg ABZ for intestinal parasites), or PZQ in the past twelve months.
- Active pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum smears.
- Systemic disease other than NCC 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 severe intracranial hypertension (ICH). Definition of severe ICH for this study would be the presence of headaches, nausea, and vomiting, and papilledema at fundoscopic examination.
- Pregnancy
- History of hypersensitivity to ABZ or PZQ
- Concurrent treatment with cimetidine, ranitidine, or theophylline.
- Chronic alcohol or drug abuse.
- Positive to Strongyloides infection
- History of reported allergy to contrast substances used in MRI.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-blind Multicenter, Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild (One or Two Lesions) Parenchymal Brain Cysticercosis, With an Open Comparison Group
The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy, with the potential to provide a single-dose therapy for this type of NCC.
The study cohort will also allow us to identify early imaging markers that predict lesion resolution, as well as factors associated with residual calcification or focal gliosis after lesion resolution. This study will also provide additional information on the safety of the study interventions.
Read the detailed description
This three-arm randomized controlled phase II/III clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mg/kg oxfendazole and a regimen with three similar doses spread over seven days (day 1, day 4 and day 7), with the most effective antiparasitic regimen available, combined albendazole plus praziquantel for ten days in individuals with mild NCC (with one to two lesions).
Participants will receive treatment with oxfendazole (one or three dose regimens) or the standard treatment (albendazole + praziquantel). At day 15 after treatment onset, an MRI will be performed to evaluate early predictors of lesion resolution. MRI at day 90 will serve to evaluate efficacy (lesion resolution) and a day 180 MRI will evaluate sequelae lesions. CT will be performed at the en of the study to confirm persistence of calcified sequelae lesion.
The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions, all in a single brain area. Lesions can be one or two adjacent, viable or degenerating NCC lesions. Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement.
- Conditions
- Brain Cysticercosis
- Being tested
- Oxfendazole single dose, Oxfendazole three doses, albendazole plus praziquantel regime
- Keywords
- Cysticercosis, Cysticercosis treatment
- Medical subject headings
- Neurocysticercosis, Cysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxfendazole single doseDrug
Also called Intervention 1
Subjects will receive active oxfendazole, 20 mg/kg/day, orally, as a single dose. Oxfendazole placebo will be used at days 4 and 7 to maintain blinding between the two intervention arms.
Oxfendazole three dosesDrug
Also called Intervention 2
Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7)
albendazole plus praziquantel regimeDrug
Also called Comparison regimen
Subjects will receive a combination of albendazole plus praziquantel, as a standard treatment for brain cysticercosis (neurocysticercosis), orally, for ten days. Albendazole will be given at 15/kg/d and praziquantel at 50/kg/d.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | OXF 20 mg/kg/d, single dose, orally Receives: Drug: Oxfendazole single dose |
| Intervention 2 | Experimental | OXF 20 mg/kg/d, for three days (1, 4 and 7), orally Receives: Drug: Oxfendazole three doses |
| Comparison regimen | Active comparator | Combined treatment with albendazole (15 mg/k/d) plus praziquantel (50 mg/k/d), for 10 days, orally. Receives: Drug: albendazole plus praziquantel regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: completely resolution or persistence only as small lesion remnants.
Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (<20% of the original lesion size).
Measured: Three months after treatment onset
Secondary outcomes (2)
Clinical effectiveness: Seizure relapses.
The frequency of seizure relapses in individuals whose lesions resolved compared to those who had remaining viable or degenerating lesions on month 3 MRI
Measured: In the initial 12 months after treatment
Safety: Serious adverse events
Proportion of participants in each group who develop serious or severe adverse events, and the numbers of adverse events per group
Measured: In the initial 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Dec 2026 (estimated)
- Primary completion15 Mar 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CysticercosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention administered orally will be done randomly, in three groups or arms; arms 1 and 2, receiving oxfendazole (OXF) in a single dose or oxfendazole in three-days regimen (days 1, 4 and 7), respectively; arm 3, receiving a ten days albendazole (ABZ) + praziquantel (PZQ) regimen.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Oxfendazole Development Group
- Responsible party
- Sponsor
- Investigators
- Hector H Garcia, MD, PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565507
- Sponsor's protocol ID
- 211661
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Multicenter, Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild (One or Two Lesions) Parenchymal Brain Cysticercosis, With an Open Comparison Group
- ClinicalTrials.gov ID
- NCT06565507
- Acronym / sponsor ID
- 211661
- Conditions
- Brain Cysticercosis
- Keywords
- Cysticercosis, Cysticercosis treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Oxfendazole Development Group
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Mar 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 22 Aug 2024 (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.
The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy, with the potential to provide a single-dose therapy for this type of NCC.
The study cohort will also allow us to identify early imaging markers that predict lesion resolution, as well as factors associated with residual calcification or focal gliosis after lesion resolution. This study will also provide additional information on the safety of the study interventions.
Detailed description
This three-arm randomized controlled phase II/III clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mg/kg oxfendazole and a regimen with three similar doses spread over seven days (day 1, day 4 and day 7), with the most effective antiparasitic regimen available, combined albendazole plus praziquantel for ten days in individuals with mild NCC (with one to two lesions).
Participants will receive treatment with oxfendazole (one or three dose regimens) or the standard treatment (albendazole + praziquantel). At day 15 after treatment onset, an MRI will be performed to evaluate early predictors of lesion resolution. MRI at day 90 will serve to evaluate efficacy (lesion resolution) and a day 180 MRI will evaluate sequelae lesions. CT will be performed at the en of the study to confirm persistence of calcified sequelae lesion.
The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions, all in a single brain area. Lesions can be one or two adjacent, viable or degenerating NCC lesions. Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The intervention administered orally will be done randomly, in three groups or arms; arms 1 and 2, receiving oxfendazole (OXF) in a single dose or oxfendazole in three-days regimen (days 1, 4 and 7), respectively; arm 3, receiving a ten days albendazole (ABZ) + praziquantel (PZQ) regimen.
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Drug: Oxfendazole single doseOXF 20 mg/kg/d, single dose, orally |
| Intervention 2 | Experimental | Drug: Oxfendazole three dosesOXF 20 mg/kg/d, for three days (1, 4 and 7), orally |
| Comparison regimen | Active comparator | Drug: albendazole plus praziquantel regimeCombined treatment with albendazole (15 mg/k/d) plus praziquantel (50 mg/k/d), for 10 days, orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female individuals between 18 and 75 years of age, with suspected viable or degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and Chandy, 1997)
- If female of child-bearing potential and men, willing to use an adequate method of contraception*, including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.
- Patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, ALT, and AST.
- Availability to grant informed consent.
Key exclusion criteria (16 listed)
- Multiple lesion sites or more than two adjacent lesions.
- Suspected neurotuberculosis (Rajshekhar's criteria) [66,67]
- More than two viable brain cysts.
- Large brain cysts (> 3cm in diameter)
- Subarachnoid neurocysticercosis or intraventricular
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 |
|---|---|---|
| Oxfendazole single doseAlso: Intervention 1Subjects will receive active oxfendazole, 20 mg/kg/day, orally, as a single dose. Oxfendazole placebo will be used at days 4 and 7 to maintain blinding between the two intervention arms. | Drug | Intervention 1 |
| Oxfendazole three dosesAlso: Intervention 2Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7) | Drug | Intervention 2 |
| albendazole plus praziquantel regimeAlso: Comparison regimenSubjects will receive a combination of albendazole plus praziquantel, as a standard treatment for brain cysticercosis (neurocysticercosis), orally, for ten days. Albendazole will be given at 15/kg/d and praziquantel at 50/kg/d. | Drug | Comparison regimen |
Primary outcome
Efficacy: completely resolution or persistence only as small lesion remnants.
Time frame: Three months after treatment onset
Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (<20% of the original lesion size).
2 secondary outcomes
Clinical effectiveness: Seizure relapses.
Time frame: In the initial 12 months after treatment
Safety: Serious adverse events
Time frame: In the initial 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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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.
Hector H Garcia, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxfendazole single dose, Oxfendazole three doses and albendazole plus praziquantel regime in people with Brain Cysticercosis, run by Universidad Peruana Cayetano Heredia.
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 16 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: opening soon, as of the sponsor's last update on 1 May 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hector H Garcia, MD, PhD (+511 3287360, hgarcia@jhsph.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: completely resolution or persistence only as small lesion remnants. (time frame: Three months after treatment onset). 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 1 May 2026.