NCT00787111

Extended Management and Measurement of Autism

Extended Management & Measurement of Autism (Emma): An Open-Label, Follow-On Study to Investigate the Safety and Impact on Developmental Trajectory of 18 Months Treatment With Fluoxetine Orally Dissolving Tablet (Odt) In Childhood and Adolescent Autistic Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Neuropharm · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine (prozac)	Formulation: ODT

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-11-07
• Last updated: 2010-02-23

Locations

13 sites across 1 country: United States