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Search / Trial NCT00259805

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

Launched by CALIFORNIA PACIFIC MEDICAL CENTER RESEARCH INSTITUTE · Nov 29, 2005

Trial Information

Current as of May 29, 2025

Completed

Keywords

Encephalitis Epilepsy Rasmussens Rituximab Autoimmune

ClinConnect Summary

Chronic Focal Encephalitis (Rasmussen's Encephalitis) is a condition characterized by a progressive hemiparesis, cognitive decline (including loss of language skills if the language dominant hemisphere is involved) and epileptic seizures that are typically refractory to medical treatment (Rasmussen). Attempts to control the seizures with anticonvulsants are ineffective and the only effective treatment to date is a hemispherectomy (surgical removal of half of the brain). Children with CFE who undergo cortical resections or hemispherectomies demonstrate an inflammatory histopathology consisti...

Gender

ALL

Eligibility criteria

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

About California Pacific Medical Center Research Institute

California Pacific Medical Center Research Institute is a leading clinical research organization affiliated with the California Pacific Medical Center in San Francisco. Focused on advancing medical knowledge and improving patient outcomes, the institute conducts innovative clinical trials across various therapeutic areas, including cardiology, oncology, and neurology. With a commitment to rigorous scientific standards and ethical research practices, the institute collaborates with academic institutions, industry partners, and healthcare providers to develop and evaluate new therapies and interventions, ultimately striving to translate research findings into effective clinical applications for diverse patient populations.

Locations

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Kenneth D Laxer, M.D.

Principal Investigator

California Pacific Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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