As I've mentioned before, diagnostic trials are pretty fast (so it bugs me that Altropane for PD has taken so long).
>>BOSTON--(BW HealthWire)--March 18, 2002-- Boston Life Sciences, Inc. (NASDAQ: BLSI - news) announced that its Phase II study to diagnose ADHD in children using Altropane, the Company's radio-imaging agent that targets the Dopamine Transporter (DAT), has been initiated. The 40 subject study will be performed at Children's Hospital of Philadelphia and University of Massachusetts Medical School in Worcester, Mass., two institutions of renowned excellence in the diagnosis and treatment of ADHD. Patient enrollment is anticipated to begin the first week of April, 2002.
The study will enter children between ages 8-17 that have an expertly-determined psychiatric diagnosis of either ADHD (20 subjects) or one of three anxiety syndromes (Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety Disorder [20 subjects]). An Altropane-SPECT scan will then be performed on each child and the indirect measure of DATs will be calculated by a nuclear medicine specialist without knowledge of the subject's previously established clinical diagnosis. The results of the ADHD group will then be statistically compared to those of the anxiety group. The working hypothesis is that children with ADHD will have a statistically-significant elevation in their calculated DATs compared to those with anxiety disorders. The degree of statistical separation of the groups will then be used in planning the Phase III study.
``The successful results in our first Phase II study in adults, which demonstrated a highly-statistically significant elevation in DAT numbers in individuals with expertly-diagnosed ADHD as compared to normal volunteers, has led us to test Altropane in children,'' stated Dr. Marc Lanser, MD, Chief Scientific Officer of BLSI. ``ADHD is often difficult to differentiate clinically from anxiety disorders in children; therefore any objective test to aid in differentiating these two groups could be of great practical importance,'' added Dr. Lanser.<<
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Cheers, Tuck |
