Efficacy and Safety of Lenalidomide for Treatment of Autistic Spectrum Disorders
|ClinicalTrials.gov Identifier: NCT00996931|
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : May 29, 2013
Last Update Posted : May 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: lenalidomide||Phase 2|
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 elevated ratios of CSF/serum levels of TNF-alpha in patients with regressive autism.
Lenalidomide (Revlimid®) is an analogue of thalidomide. Based on the improved clinical efficacy predicted for Revlimid® in its effects on TNF-alpha and other immunomodulatory cytokines, this oral compound may prove efficacious with less toxicity compared with thalidomide.
The study will evaluate the efficacy of lenalidomide by measurement of changes in EEG, clinical global impression, Childhood Autism Rating Scale, and serum and CSF (if available) TNF-alpha at the end of the study compared with the same measurements at baseline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study to Determine Efficacy and Safety of Lenalidomide (Revlimid) for Treatment of Autistic Spectrum Disorders(ASD) With Regression and Markers of Cerebrospinal Fluid Cytokine Elevation and Elevated TNF-alpha Levels|
|Study Start Date :||February 2009|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
2.5 mgs per day orally for 12 weeks
Other Name: Revlimid
- Change in TNF-alpha Levels [ Time Frame: Baseline and 12 weeks ]Change in CSF-TNF-α from baseline to 12 weeks.
- Change in Childhood Autism Rating Scale (CARS)Value From Baseline to 6 Weeks [ Time Frame: Baseline and 6 weeks ]Change in CARS value from baseline to 6 weeks. Total CARS scores range from a fifteen to 60, with a minimum score of thirty serving as the cutoff for a diagnosis of autism on the mild end of the autism spectrum.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996931
|Principal Investigator:||Michael Chez, MD||Sutter Medical Foundation|