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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00545493
Date of registration: 16/10/2007
Prospective Registration: No
Primary sponsor: University Hospital, Bonn
Public title: Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis
Scientific title: Efficacy of Tacrolimus and i.v.-Immunoglobulins in Rasmussen Encephalitis With Start of Treatment in the Acute Disease Stage. Prospective, Randomised, Open Parallel Group Study
Date of first enrolment: November 2002
Target sample size: 16
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00545493
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2/Phase 3
Countries of recruitment
Germany
Contacts
Name:     Christian G Bien, M.D.
Address: 
Telephone:
Email:
Affiliation:  University Hospital Bonn, Bonn, Germany
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients meeting at least two of the following three criteria:

1. Clinical: Epilepsia partialis continua or progressive* hemiparesis

2. MRI: Progressive* cerebral hemiatrophy

3. Histopathology: T cell dominated encephalitis with activated microglial cells
(typically, but not necessarily forming nodules) and reactive astrogliosis.
Numerous macrophages, B cells or plasma cells or positive signs of viral
infections (viral inclusion bodies or immunohistochemical demonstration of viral
protein) exclude the diagnosis of RE.

- "Progressive" means that at least two sequential clinical examinations or
MRI studies documenting increasing deficits or tissue loss are required to
meet the respective criteria.

Exclusion Criteria:

- Neuroradiological signs of a bihemispheric encephalitis.

- Wave-like course with history of repeated remissions.

- Infectious disease as a contraindication to an immunosuppressive therapy.

- Paraneoplastic encephalitis.

- Previous treatment with > 3 weeks of corticosteroids or tacrolimus or > 1,2 g/kg IVIG
or > 5 PEX/PAI within the last three months.

- Onset of acute disease stage more than 12 months ago.

- Patient already in residual stage, i.e., stable neurological deficit since >6 months.

- Hemispheric Ratio < 80% (< 90% in patients > 11 years)

- Histopathological evidence of cerebral inclusion bodies indicating a viral infection



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rasmussen Encephalitis
Intervention(s)
Drug: Tacrolimus
Drug: i.v. immunoglobulins
Primary Outcome(s)
Time to exit, criteria: Deterioration of motor function of the affected side by 15 % (>11 yrs of age: 8%) measured by the "Motricity Index" (scale 0-100) or deterioration of the "Hemispheric ratio" assessed by regular MRI scans by 15% (>11 yrs: 8%). [Time Frame: until final included subject has been followed for one yer]
Secondary Outcome(s)
seizure frequency, "Burden of disease" scale, neuropsychological performance, quality of life, T cell receptor studies (H Wiendl, Würzburg) [Time Frame: until final included subject has been followed for one yer]
Secondary ID(s)
135/02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Octapharma
Astellas Pharma GmbH
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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