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

February 9, 2006
September 25, 2008
July 2007
June 2009   (final data collection date for primary outcome measure)
Cumulative frequency of partial, generalized, and total seizures [ Time Frame: Through Day 42 ] [ Designated as safety issue: Yes ]
Cumulative frequency of partial, generalized, and total seizures from Days 11 to 42
Complete list of historical versions of study NCT00290823 on ClinicalTrials.gov Archive Site
Cumulative frequency of generalized seizures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Cumulative frequency of generalized seizures
Not Provided
Not Provided
 
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Treatment of Intraparenchymal Neurocysticercosis: Effect of Increased Dosing of Corticosteroids on Seizure Frequency

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neurocysticercosis
  • 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: 1
    Participants will receive 6 mg dexamethasone daily for 10 days Participants will also receive albendazole and omeprazole.
    Interventions:
    • Drug: Albendazole
    • Drug: Dexamethasone
    • Drug: Omeprazole
  • 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.
    Interventions:
    • Drug: Albendazole
    • Drug: Dexamethasone
    • Drug: Omeprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Peru
 
NCT00290823
05IN214, 05-I-N214
Not Provided
Theodore E. Nash, MD, Gastrointestinal Parasites Section, Laboratory of Parasitic Diseases, NIAID
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
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
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP