Status:
COMPLETED
Efficacy and Safety of Lenalidomide for Treatment of Autistic Spectrum Disorders
Lead Sponsor:
Sutter Medical Foundation
Conditions:
Autism
Eligibility:
MALE
6-16 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory cytokines including TNF-alpha and may actually alter the clinical course of autism for some children.
Detailed Description
Autism currently affects 1:142 births and has no definite cause. Recent research has shown possible identifying markers in neuroglial inflammation with elevated cytokines IL-1, Il-6, and MCP-1 and ele...
Eligibility Criteria
Inclusion
- Diagnosis of autistic spectrum disorder as defined by DSM-IV criteria.
- Inflammatory CSF and serum markers with elevated level of TNF-Alfa (\> 50pg/ml) or other Cytokine markers such as IL-1, IL-6 or MECP-1, or serum levels of such cytokines greater than 2X normal levels even in absence of CSF markers.
- or
- Patients with interictal epiliptiform EEG changes in the absences of clinical seizures, if CSF inflammatory markers are identified.
- Patients will maintain any other baseline medications for autistic problems or EEG treatment as long as on these for prior 6-8 weeks with no dosage changes. Mentally impaired minors require a parent or legal guardian to sign the informed consent.
Exclusion
- -Diagnosis of PPD-NOS and other autism spectrum disorders.
- Any serious medical condition, laboratory abnormality, genetic, brain, structural, or psychiatric illness that would prevent the subject from participating.
- History of neutropenia, thrombocytopenia or other types of myelosuppression or risk factors for myelosuppression.
- History or risk factors for thromboembolic events.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Current use of steroids (e.g. dexamethasone, prednisone), anthracyclines (Doxil, Adriamycin).
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Known positive for HIV or infectious hepatitis, type A, B or C or tuberculosis.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00996931
Start Date
February 1 2009
End Date
December 1 2009
Last Update
May 29 2013
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