Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

• ClinicalTrials.gov Identifier: NCT00290823
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Last Update Posted: February 3, 2017
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Neurocysticercosis	Drug: Albendazole; Drug: Dexamethasone; Drug: Omeprazole	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
• Study Start Date: April 2006
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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
Experimental: 2; 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

Outcome Measures

Primary Outcome Measures :

1. Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ]

Secondary Outcome Measures :

1. Cumulative frequency of generalized seizures [ Time Frame: Throughout study ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Peru

Instituto Especializado en Ciencias Neurologicas

Lima, Peru

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: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00290823
• Obsolete Identifiers: NCT00344396
• Other Study ID Numbers: 05IN214; 05-I-N214
• First Posted: February 13, 2006
• Last Update Posted: February 3, 2017
• Last Verified: February 2017

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

Taenia; Seizures; Tapeworm; Parasite

Additional relevant MeSH terms:

Neurocysticercosis; Cysticercosis; Taeniasis; Seizures; Neurologic Manifestations; Nervous System Diseases; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Parasitic Diseases; Cestode Infections; Helminthiasis; Central Nervous System Infections; Central Nervous System Diseases; Albendazole; Dexamethasone; Omeprazole; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Enzyme Inhibitors