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Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

Primary Purpose

Neurocysticercosis

Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
Albendazole
Dexamethasone
Omeprazole
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurocysticercosis focused on measuring Taenia, Seizures, Tapeworm, Parasite

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Especializado en Ciencias Neurologicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Cumulative frequency of partial, generalized, and total seizures

Secondary Outcome Measures

Cumulative frequency of generalized seizures

Full Information

First Posted
February 9, 2006
Last Updated
February 2, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00290823
Brief Title
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Official Title
Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocysticercosis
Keywords
Taenia, Seizures, Tapeworm, Parasite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
400 mg tablet taken orally twice daily
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
6mg or 8mg taken daily
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
20 mg tablet taken orally daily
Primary Outcome Measure Information:
Title
Cumulative frequency of partial, generalized, and total seizures
Time Frame
Through Day 42
Secondary Outcome Measure Information:
Title
Cumulative frequency of generalized seizures
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore E. Nash, MD
Organizational Affiliation
Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hector H. Garcia, MD, PhD
Organizational Affiliation
Department of Microbiology, Universidad Peruana Cayetano Heredia
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Especializado en Ciencias Neurologicas
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
16170737
Citation
Del Brutto OH. Neurocysticercosis. Semin Neurol. 2005 Sep;25(3):243-51. doi: 10.1055/s-2005-917661.
Results Reference
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PubMed Identifier
8093496
Citation
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.
Results Reference
background
PubMed Identifier
2302008
Citation
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.
Results Reference
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Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

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