Clinical Trial: Extended Management and Measurement of Autism

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Extended Management & Measurement of Autism (Emma): An Open-Label, Follow-On Study to Investigate the Safety and Impact on Developmental Trajectory of 18 Months Treatm

Brief Summary: This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period.

Detailed Summary:

This research study will monitor the safety of fluoxetine in all patients after their completion of the previous clinical study, in which they received fluoxetine or placebo. The study will look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period. A possible total of 128 children and adolescents with AD will participate in the study from sites across the US.

The study is open-label. All of the subjects in this study will receive the active medicine fluoxetine orally dissolving tablets (ODT). Children will begin by receiving a daily dose of 2mg fluoxetine for two weeks. The family and child will be asked to come back to the clinic 2 weeks later and, depending on the child's tolerance and response to the medicine, may have his or her dose increased to 4mg/day. After this visit, the time between visits to the clinic and the dose that the child will receive will be decided by the study investigator based on their clinical judgment on benefit versus tolerability. The largest daily dose of fluoxetine that the child could receive in this study is 54mg.

Sponsor: Neuropharm

Current Primary Outcome: Safety Outcomes: Laboratory determinations, Urine drugs of abuse tests,Vital Signs,Physical Examinations, Adverse Events/Serious Adverse Events, Clinical Global Impression of Severity (CGI-S AD) [ Time Frame: through the study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Neuropharm

Dates:
Date Received: November 5, 2008
Date Started: November 2008
Date Completion:
Last Updated: February 22, 2010
Last Verified: February 2010