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Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Primary Purpose

Epilepsy, Cysticercosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
albendazole
dexamethasone
phenytoin
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring cysticercosis, epilepsy, immunologic disorders and infectious disorders, neurologic and psychiatric disorders, parasitic infection, rare disease, seizures

Eligibility Criteria

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

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy --Prior/Concurrent Therapy-- No prior therapy for cysticercosis --Patient Characteristics-- Age: 16 to 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus Other: No unstable condition due to systemic disease or cysticercosis Not pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004403
    Brief Title
    Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis. II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain. III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either albendazole and dexamethasone or placebo. Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year. Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15. Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3 months for 3 years. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Cysticercosis
    Keywords
    cysticercosis, epilepsy, immunologic disorders and infectious disorders, neurologic and psychiatric disorders, parasitic infection, rare disease, seizures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    120 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    albendazole
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    phenytoin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy --Prior/Concurrent Therapy-- No prior therapy for cysticercosis --Patient Characteristics-- Age: 16 to 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus Other: No unstable condition due to systemic disease or cysticercosis Not pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert H. Gilman
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

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