Treatment of Patients With Cysticercosis With Praziquantel or Albendazole - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001205

Purpose

The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement.

Patients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 _ to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include:

Blood tests.
X-rays of the head and long bones.
Electroencephalogram - recording of the electrical activity of the brain
Lumbar puncture (spinal tap) - examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
Eye examination.
Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure.
Computed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner.

Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.

Condition	Intervention
Cysticercosis	Drug: Praziquantel Drug: Albendazole

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Treatment of Cysticercosis Including Neurocysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities

Resource links provided by NLM:

Drug Information available for: Albendazole Praziquantel

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Duration of enrollment will be dependent on the patient's response to therapy. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 1985
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 2020 (Final data collection date for primary outcome measure)

Intervention Details:

N/A

Detailed Description:

The purpose of this protocol is to allow evaluation, treatment and follow up of patients with cysticercosis. Cysticercosis is defined as an infection with the larvae form of T.solium and includes infection of the brain (neurocysticercosis) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment follows accepted clinical practice and information learned is observational. Two drugs, praziquantel and albendazole, have been used extensively in the treatment of cysticercosis and are the accepted therapies. Albendazole has recently been approved for the treatment of cysticercosis while praziquantel is not approved by the FDA but has proven efficacy and safety. To decrease the provoked inflammation which can be induced by treatment or to decrease inflammation in active disease, corticosteroids or other immunosuppressive agents may be used. Anti seizure medications are also commonly used.

Eligibility

Ages Eligible for Study:	1 Year to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Patients aged 1 to 75 years will be considered for therapy. Children under age 18 normally will be eligible for use of immunosuppressives other than corticosteroids. Children who have cysticercosis and are younger than age 18 years are rarely seen at the clinical center; therefore, use of these medications in children will require a special exemption.

Patients with proven or likely neurocysticercosis. The diagnosis of neurocysticercosis depends on the presence of cysts by MRI or CT scan and/or the presence of typical calcifications by CT. Serology is usually, but not necessarily, positive.

Willing to sign consent and be seen at prescribed intervals.

Patients who are pregnant will be included, however, they will not be offered treatment with albendazole, praziquantel and/or methotrexate during the pregnancy unless the clinical condition is severe, eg. life threatening, in the opinion of the PI. They may receive coritcosteroids.

Exclusions:

Less than 1 year of age.
Unwilling to undergo effective birth control measures if use of anthelmintics or immunosuppressives (other than corticosteroids) is required.
Breast feeding if antihelmintics or immunosuppressive medications are required.
Allergic to albendazole and praziquantel
Active tuberculosis or strongyloides or other infections made worse with immunosuppression or other infections likely to be made worse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001205

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Dachman WD, Adubofour KO, Bikin DS, Johnson CH, Mullin PD, Winograd M. Cimetidine-induced rise in praziquantel levels in a patient with neurocysticercosis being treated with anticonvulsants. J Infect Dis. 1994 Mar;169(3):689-91.

Del Brutto OH, Campos X, Sanchez J, Mosquera A. Single-day praziquantel versus 1-week albendazole for neurocysticercosis. Neurology. 1999 Mar 23;52(5):1079-81.

Proano JV, Madrazo I, Garcia L, Garcia-Torres E, Correa D. Albendazole and praziquantel treatment in neurocysticercosis of the fourth ventricle. J Neurosurg. 1997 Jul;87(1):29-33.

Responsible Party:	Theodore E. Nash, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00001205 History of Changes
Other Study ID Numbers:	850127, 85-I-0127
Study First Received:	November 3, 1999
Last Updated:	December 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

T. Solium
Cysticercosis
Praziquantel

Additional relevant MeSH terms:

Cysticercosis
Taeniasis
Neurocysticercosis
Cestode Infections
Helminthiasis
Parasitic Diseases
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Albendazole
Praziquantel

Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012