Oxfendazole in Mild Parenchymal Brain Cysticercosis

NCT06565507 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 211661
• Study Type: interventional
• Target: 544
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Brain Cysticercosis

Keywords

Cysticercosis; Cysticercosis treatment

Outcome Measures

Primary Outcomes (1)

• 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).

  Three months after treatment onset

Secondary Outcomes (2)

• Clinical effectiveness: Seizure relapses.

  In the initial 12 months after treatment

• Safety: Serious adverse events

  In the initial 12 months after treatment

Other Outcomes (7)

• Early imaging markers predicting lesion resolution.

  Month 3

• Antiparasitic treatment type associated with gliosis or residual calcification.

  Month 6 and month 12

• Antiparasitic treatment type associated with seizure relapses.

  During the initial 12 months after antiparasitic treatment.

Study Arms (3)

Intervention 1

EXPERIMENTAL

OXF 20 mg/kg/d, single dose, orally

Drug: Oxfendazole single dose

Intervention 2

EXPERIMENTAL

OXF 20 mg/kg/d, for three days (1, 4 and 7), orally

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.

Drug: albendazole plus praziquantel regime

Interventions

Oxfendazole single dose DRUG

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.

Also known as: Intervention 1

Intervention 1

Oxfendazole three doses DRUG

Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7)

Also known as: Intervention 2

Intervention 2

albendazole plus praziquantel regime DRUG

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.

Also known as: Comparison regimen

Comparison regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Oxfendazole Development Group: collaborator

MeSH Terms

Conditions

Neurocysticercosis; Cysticercosis

Interventions

oxfendazole; Albendazole

Condition Hierarchy (Ancestors)

Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Taeniasis; Cestode Infections; Helminthiasis; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hector H Garcia, MD, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector H Garcia, MD, PhD

CONTACT

+511 3287360; hgarcia@jhsph.edu

Javier A Bustos, MD, PhD

CONTACT

+511 3284038; javier.bustos.p@upch.pe

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is a double-blind trial in regards to dose regime of OXF. Neither the investigators nor the subjects know which dose of OXF a given subject is receiving, although subjects and clinical study staff will know whether they are receiving one of the OXF regimes or active ABZ+PZQ.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 22, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04