Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00290823

Purpose

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).

Condition	Intervention	Phase
Neurocysticercosis	Drug: Albendazole Drug: Dexamethasone Drug: Omeprazole	Phase III

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Albendazole Corticosteroids Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cumulative frequency of generalized seizures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole.	Drug: Albendazole 400 mg tablet taken orally twice daily Drug: Dexamethasone 6mg or 8mg taken daily Drug: Omeprazole 20 mg tablet taken orally daily
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 400 mg tablet taken orally twice daily Drug: Dexamethasone 6mg or 8mg taken daily Drug: Omeprazole 20 mg tablet taken orally daily

Detailed Description:

NCC is the most common parasitic infection of the central nervous system (CNS). It is caused by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic problems may occur in a patient with NCC. Corticosteroids are the current standard of care for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat infections caused by worms; however, it is unclear if its use with the corticosteroid dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone with tapered dosing when given with albendazole, as compared to standard dexamethasone and albendazole treatment, in NCC patients.

In this open label study, patients will be randomly assigned to one of two arms. Group I will receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a 360-day period. Blood collection will occur at most visits. Group II will also undergo sputum smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on Day 360.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Inability to undergo CT or MRI
Hypersensitivity to albendazole, antiepileptic drugs, or contrast
Hypertension at rest
Require corticosteroids, received corticosteroids in the 4 weeks prior to study entry, or received corticosteroids for 9 or more days within the 6 months prior to study entry
Other CNS processes that may interfere with study assessments
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290823

Locations

Peru
Instituto Especializado en Ciencias Neurologicas	Recruiting
Lima, Peru
Contact: Hector H. Garcia, MD, PhD +511 3287360 hgarcia@jhsph.edu
Principal Investigator: Theodore E. Nash, MD
Principal Investigator: Hector H. Garcia, MD, PhD

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:	Theodore E. Nash, MD	Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID
Study Director:	Hector H. Garcia, MD, PhD	Department of Microbiology, Universidad Peruana Cayetano Heredia

More Information

Publications:

Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. Review.

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.

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.

Responsible Party:	Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID ( Theodore E. Nash, MD )
Study ID Numbers:	05IN214, 05-I-N214
Study First Received:	February 9, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00290823
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Taenia
Seizures
Tapeworm
Parasite

Study placed in the following topic categories:

Dexamethasone
Albendazole
Central Nervous System Infections
Seizures
Omeprazole
Central Nervous System Diseases

Cysticercosis
Parasitic Diseases
Taeniasis
Neurocysticercosis
Helminthiasis
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Central Nervous System Helminthiasis
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Central Nervous System Parasitic Infections
Antiparasitic Agents
Therapeutic Uses
Anti-Ulcer Agents
Antineoplastic Agents, Hormonal

Antiplatyhelmintic Agents
Nervous System Diseases
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Anthelmintics
Antimitotic Agents
Glucocorticoids
Pharmacologic Actions
Anticestodal Agents
Autonomic Agents
Tubulin Modulators
Cestode Infections
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009