Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

February 2, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Instituto Especializado en Ciencias Neurologicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative frequency of partial, generalized, and total seizures
Time Frame: Through Day 42
Through Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative frequency of generalized seizures
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05IN214
  • 05-I-N214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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