A Pilot Study of the Use of Rituximab in the Treatment of Chronic Focal Encephalitis

Completed · Phase 1

Conditions studied: Chronic Focal Encephalitis, Rasmussen's Encephalitis

In brief

The purpose of this study is to assess the safety, tolerability and effectiveness of rituximab in the treatment of chronic focal encephalitis.

Key facts

Study ID

NCT00259805

Run by

California Pacific Medical Center Research Institute

People needed

10

Starts

2005-01-01

Expected to finish

2008-12-01

Last updated by the study team

2013-03-22

Who can join

Age: 5 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic focal encephalitis
• IgG \& IgM levels within normal limits
• Adequate renal function
• Stable anticonvulsant drug regimen

You may not qualify if…

• Evidence of significant ongoing medical condition or progressive neurologic condition (other than CFE)
• Previous treatment with rituximab
• History of significant recurrent infections, or ongoing active infection
• Receipt of a live vaccine within 4 weeks prior to treatment
• History of severe allergic reactions to humanized or murine monoclonal antibodies
• History of drug, alcohol or chemical abuse within 6 months
• Concomitant malignancies or previous malignancy
• Use of steroids or immunoglobulins during the 4 weeks prior to treatment
• Hemoglobin <8.5 gm/dL, Platelets < 100,00/mm, AST or ALT >2.5 ULN
• Positive Hepatitis B or C serology
• History of positive HIV

Where it is running

• California Pacific Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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