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Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2001

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

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

Estimated Enrollment: 120
Study Start Date: May 2000
Estimated Study Completion Date: March 2002
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


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004403

Sponsors and Collaborators
Johns Hopkins University
Study Chair: Robert H. Gilman Johns Hopkins University
  More Information Identifier: NCT00004403     History of Changes
Other Study ID Numbers: 199/13286
Study First Received: October 18, 1999
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
immunologic disorders and infectious disorders
neurologic and psychiatric disorders
parasitic infection
rare disease

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cestode Infections
Parasitic Diseases
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Central Nervous System Infections
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiparasitic Agents
Anti-Infective Agents processed this record on September 21, 2017