Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Johns Hopkins University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004403

Purpose

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.

Condition	Intervention
Epilepsy Cysticercosis	Drug: albendazole Drug: dexamethasone Drug: phenytoin

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Dexamethasone Phenytoin Albendazole Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	120
Study Start Date:	May 2000

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.

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004403

Sponsors and Collaborators

FDA Office of Orphan Products Development

Johns Hopkins University

Investigators

Study Chair:

Robert H. Gilman

Johns Hopkins University

More Information

No publications provided

Study ID Numbers:	199/13286, JHUSHPH-FDR001107
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004403 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cysticercosis
epilepsy
immunologic disorders and infectious disorders
neurologic and psychiatric disorders

parasitic infection
rare disease
seizures

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Brain Diseases
Neurocysticercosis
Hormones
Albendazole
Phenytoin
Mental Disorders
Cysticercosis
Parasitic Diseases
Taeniasis

Helminthiasis
Dexamethasone acetate
Antineoplastic Agents, Hormonal
Seizures
Rare Diseases
Central Nervous System Diseases
Anthelmintics
Antimitotic Agents
Glucocorticoids
Central Nervous System Infections
Epilepsy
Tubulin Modulators
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
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
Brain Diseases
Neurocysticercosis
Hormones
Central Nervous System Parasitic Infections
Albendazole

Antiparasitic Agents
Therapeutic Uses
Cysticercosis
Parasitic Diseases
Taeniasis
Helminthiasis
Antineoplastic Agents, Hormonal
Antiplatyhelmintic Agents
Mitosis Modulators
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Anthelmintics
Antimitotic Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 07, 2009