Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

NCT00290823 | Completed Phase 3

• 2 other identifiers: 05IN21405-I-N214
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).

Conditions

Neurocysticercosis

Keywords

Taenia; Seizures; Tapeworm; Parasite

Outcome Measures

Primary Outcomes (1)

• Cumulative frequency of partial, generalized, and total seizures

  Through Day 42

Secondary Outcomes (1)

• Cumulative frequency of generalized seizures

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole.

Drug: Albendazole; Drug: Dexamethasone; Drug: Omeprazole

2

EXPERIMENTAL

Participants will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Participants will also receive albendazole and omeprazole.

Drug: Albendazole; Drug: Dexamethasone; Drug: Omeprazole

Interventions

Albendazole DRUG

400 mg tablet taken orally twice daily

1; 2

Dexamethasone DRUG

6mg or 8mg taken daily

1; 2

Omeprazole DRUG

20 mg tablet taken orally daily

1; 2

Eligibility Criteria

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

You may qualify if:

• Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)
• Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry
• Willingness to be hospitalized for a minimum of 2 weeks for this study
• PPD negative OR negative smears for tuberculosis (TB) if PPD positive
• Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy

You may not qualify if:

• Primary generalized seizures not caused by NCC
• Subarachnoid or ventricular NCC
• Any vesicular lesion greater than 2 cm in diameter
• Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.
• Intracranial hypertension, as confirmed by CT or MRI
• History of status epilepticus
• Focal neurological defects
• Unstable or consistently abnormal vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure)
• Cysts in critical regions, including brainstem or the eyes
• Pulmonary TB
• History of TB in the patient or history of TB in close contact of patient
• Chest x-ray suggestive of past or current TB
• Diabetes
• Systemic conditions (e.g., chronic kidney failure, liver disease, heart failure, steroid-dependent immune diseases) other than NCC that may interfere with the study
• Predicted survival time of less than 1 year

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Instituto Especializado en Ciencias Neurologicas

Lima, Peru

Location

Related Publications (3)

• Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. doi: 10.1055/s-2005-917661.

  PMID: 16170737 BACKGROUND

• Garcia HH, Gilman R, Martinez M, Tsang VC, Pilcher JB, Herrera G, Diaz F, Alvarado M, Miranda E. Cysticercosis as a major cause of epilepsy in Peru. The Cysticercosis Working Group in Peru (CWG). Lancet. 1993 Jan 23;341(8839):197-200. doi: 10.1016/0140-6736(93)90064-n.

  PMID: 8093496 BACKGROUND

• Medina MT, Rosas E, Rubio-Donnadieu F, Sotelo J. Neurocysticercosis as the main cause of late-onset epilepsy in Mexico. Arch Intern Med. 1990 Feb;150(2):325-7.

  PMID: 2302008 BACKGROUND

MeSH Terms

Conditions

Neurocysticercosis; Seizures; Cestode Infections

Interventions

Albendazole; Dexamethasone; Omeprazole

Condition Hierarchy (Ancestors)

Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Cysticercosis; Taeniasis; Helminthiasis; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Theodore E. Nash, MD

  Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID

  PRINCIPAL INVESTIGATOR

• Hector H. Garcia, MD, PhD

  Department of Microbiology, Universidad Peruana Cayetano Heredia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

PE (1)