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WithdrawnNCT00133458Updated Jan 30, 2019

RCT ALB for SA Cysticercosis

A Phase 3 interventional study of Albendazole in Subarachnoid Cysticercosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Withdrawn at 4 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named Taenia solium. Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. This study will determine if two months of albendazole (ABZ) therapy is better than one-month. The study will last 3 years.

Read the detailed description

This is a randomized, double blind comparison of two lengths of albendazole thereapy for subarachnoid cysticercosis. It will enroll 120 individuals, male and female age 18 to 65, and diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named Taenia solium. Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. This study will determine if two months of albendazole (ABZ) therapy is better than one-month. The study will last 3 years.

02

Conditions studied

  • Subarachnoid Cysticercosis

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Keywords

  • Albenza, Subarachnoid cysticercosis
03

In context

Cysticercosis

10 studies on the registry are indexed under Cysticercosis; 2 are open to participants now.

Browse Cysticercosis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female individuals between 18-65 year of age with a diagnosis of basal subarachnoid cysticercosis, based on MRI and confirmed by serological test.
  • Willingness to accomplish the two weeks minimal hospitalization required.
  • Female of willing to use an adequate method of 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 , counts, total white blood cells, glucose, creatinine, , , AST, and electrolytes.
  • Negative fecal exam for Taenia eggs.

Exclusion criteria

Exclusion Criteria:

  • Previous therapy with albendazole (does not include patients who received single-dose 400 mg ABZ for intestinal parasites), or praziquantel.
  • Pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum smears.
  • Pre-existing diagnosis of diabetes
  • 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 -dependent immune diseases. Identification of systemic diseases will be left to the discretion of each Site PI.
  • 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 (all of them). Patients in this category can be considered for entrance into the study only after treatment of ICH by ventricle-peritoneal shunting. Patients with CT findings compatible with intracranial hypertension will have neurosurgical evaluation (by non study personal) before study entry.
  • Pregnancy
  • History of to albendazole
  • Concurrent treatment with praziquantel, cimetidine or teophylline.
  • Chronic alcohol or drug abuse
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
0 participants (actual)

Interventions

06

Study locations

4 sites
  • Facultad de Medicina de Riberao
    Riberao Preto, 14020-380, Brazil
  • Instituto Neurologico de Antioquia
    Medellin, Colombia
  • Neurology Service, Hospital -Clinica Kennedy
    Guayaquil, Ecuador
  • Universidad Peruana Cayetano Heredia
    Lima, Peru
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00133458
First posted
Aug 23, 2005
Completion
Jun 2007
Last update
Jan 30, 2019
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Albendazole

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