Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00290823
First received: February 9, 2006
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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).


Condition Intervention Phase
Neurocysticercosis
Drug: Albendazole
Drug: Dexamethasone
Drug: Omeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cumulative frequency of generalized seizures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: July 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00290823

Locations
Peru
Instituto Especializado en Ciencias Neurologicas Recruiting
Lima, Peru
Contact: Hector H. Garcia, MD, PhD    +511 3287360    hgarcia@jhsph.edu   
Principal Investigator: Theodore E. Nash, MD         
Principal Investigator: Hector H. Garcia, MD, PhD         
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Theodore E. Nash, MD, Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID
ClinicalTrials.gov Identifier: NCT00290823     History of Changes
Obsolete Identifiers: NCT00344396
Other Study ID Numbers: 05IN214, 05-I-N214
Study First Received: February 9, 2006
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Taenia
Seizures
Tapeworm
Parasite

Additional relevant MeSH terms:
Central Nervous System Parasitic Infections
Parasitic Diseases
Seizures
Neurocysticercosis
Cysticercosis
Taeniasis
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Helminthiasis
Cestode Infections
Helminthiasis
Central Nervous System Infections
Albendazole
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Omeprazole
BB 1101
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents

ClinicalTrials.gov processed this record on July 20, 2014