Neurocysticercosis: Combined Treatment With Praziquantel and Albendazole
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurocysticercosis; Epilepsy
Intervention: praziquantel (Drug); albendazole (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Universidad Peruana Cayetano Heredia Official(s) and/or principal investigator(s):
Hector H. Garcia, MD, Principal Investigator, Affiliation: Universidad Peruana Cayetano Heredia
E. Javier Pretell, MD, Principal Investigator, Affiliation: Hospital Alberto
Javier A. Bustos, MD, Principal Investigator, Affiliation: Universidad Peruana Cayetano Heredia
Overall contact:
Hector H. Garcia, MD, Phone: 511 328 7360, Email: hgarcia@jhsph.edu
Summary
The purpose of this study is to determine if combination drug therapy of praziquantel and
albendazole is safe and effective to cure neurocysticercosis.
Clinical Details
Official title: Antiparasitic Therapy for Neurocysticercosis: Phase II/III Study on Safety and Efficacy of Combined Treatment With Praziquantel and Albendazole
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Maximum plasma concentration (Cmax) and area under the curve (AUC), for ABZSO4 and PZQ
Secondary outcome: Difference in plasma levels of ABZ between patients in the ABZ+PCB group compared to those in the ABZ+PZQ group.effects of phenytoin and carbamazepine in PZQ levels when given in addition to ABZ, dexamethasone, and ranitidine. safety of the combination ABZ+PZQ compared to ABZ alone
Detailed description:
Neurocysticercosis (NCC) is the single major cause of acquired or late-onset epilepsy in the
world, and a common diagnosis in immigrant populations in the United States and other
industrialized countries. An estimated 50 million humans are affected by NCC. The disease
occurs when a parasite called Taenia solium, or the pig tapeworm, infects the brain, forming
cysts. NCC is generally treated with 1 of 2 drugs, praziquantel (PZQ) or albendazole (ABZ).
However, current treatment with either of these drugs alone is not totally effective.
The goal of this trial is to determine if combination drug therapy of PZQ and ABZ is safe and
more effective to cure NCC than either drug administered alone. This trial will consist of
both a sub-study and a parent study.
In the sub-study—which will be performed as the initial part and guide to the design of the
parent study—32 participants will be randomly chosen to receive either ABZ and PZQ or ABZ and
placebo (an inactive substance) for 10 days. Both groups will also receive other standard
medications to manage the disease. Participants will stay in the hospital for at least 2
weeks after treatment begins. After discharge from the hospital, participants will have
follow-up visits. During one of the visits, participants will provide an additional blood
sample for safety testing. Participants will be followed for 3 months. The purpose of this
sub-study is to evaluate the safety and pharmacokinetics of ABZ and PZQ.
In the parent study, a total of 180 participants (including the 32 participants from the
sub-study) will be randomly chosen to receive either ABZ and PZQ or ABZ and placebo for 10
days. Both groups will also receive other standard medications to manage the disease
including appropriate anti-epileptic drug therapy. Participants will stay in the hospital for
at least 2 weeks after treatment begins, which includes 5 days after the end of
anti-parasitic treatment. After discharge from the hospital, follow-up visits will be on days
22 and 30 after treatment begins, then monthly until day 90, and finally every 3 months until
completing 18 months. Brain images will be taken at 6 and 12 months after treatment begins.
For participants, duration of the trial is 1 year and a half.
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female individuals between 16 to 65 years of age, with a diagnosis of NCC and
20 or less viable cysts.
- Patients with a diagnosis of epilepsy secondary to NCC and a history of one or more
spontaneous seizures within the previous year but not longer than 10 years.
- Willingness to complete a minimum of two weeks of hospitalization.
Exclusion Criteria:
- Primary generalized seizures (e. g., not caused by neurocysticercosis)
- A history of generalized status epilepticus.
- Patients with persistent or progressive symptomatic intracranial hypertension or
intracranial hypertension.
- Previous therapy with ABZ or PZQ in the past two years.
- Pulmonary tuberculosis, or symptoms compatible with tuberculosis not otherwise
explained.
- Active hepatitis
- Systemic disease that may affect short-term prognosis.
- Patients in unstable condition (consistently abnormal vital signs: body temperature,
heart rate, respiratory rate, and blood pressure)
- Pregnancy during anti-parasitic treatment
- History of hypersensitivity to ABZ or PZQ
- Concurrent treatment with cimetidine or teophylline
- Chronic alcohol or drug abuse
Locations and Contacts
Hector H. Garcia, MD, Phone: 511 328 7360, Email: hgarcia@jhsph.edu
Universidad Peruana Cayetano Heredia, Lima, Peru; Recruiting
Hector H. Garcia, MD, Phone: 511 328 7360, Email: hgarcia@jhsph.edu
Instituto Nacional de Ciencias Neurologicas, Lima, Peru; Recruiting
Hector H. Garcia, MD, Phone: 511 328 7360, Email: hgarcia@jhsph.edu
Hospital Alberto Sabogal, Lima, Peru; Recruiting
E. Javier Pretell, MD, Phone: 511 328 7360, Email: epretell@viabcp.com
Additional Information
Starting date: July 2007
Ending date: July 2008
Last updated: January 7, 2008
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