Extended Management and Measurement of Autism (EMMA)

This study has been terminated.
Sponsor:
Collaborator:
Autism Speaks
Information provided by:
Neuropharm
ClinicalTrials.gov Identifier:
NCT00787111
First received: November 5, 2008
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
Drug: Fluoxetine (prozac)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Treatment With Fluoxetine Orally Dissolving Tablet (Odt) In Childhood and Adolescent Autistic Disorder

Resource links provided by NLM:


Further study details as provided by Neuropharm:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluoxetine ODT
Fluoxetine ODT ranging from 2mg to 54mg
Drug: Fluoxetine (prozac)
Formulation: ODT

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have met the inclusion criteria for the preceding double-blind SOFIA Study, and must have completed at least 10 weeks of treatment in the 14 week SOFIA study or have withdrawn from the SOFIA study due to worsening of clinical symptoms (i.e. a CGI-I-AD of 6 or 7 which, in the Investigator's opinion, required alternative intervention except symptoms of activation which could not be ameliorated by reduction in dose).
  2. Patients must have been free of fluoxetine and other SSRI's for 4 weeks prior to the first dose of open-label medication (washout).
  3. Female patients who have reached menarche must have a negative pregnancy test at baseline and as required, in the opinion of the Investigator.
  4. Females of childbearing potential must be using a medically accepted means of contraception not affected by fluoxetine treatment, or must remain abstinent for the duration of the study.
  5. Patients must be able to follow the Investigator's instructions and be able to comply with visit requirements
  6. Each Legally Authorized Representative (usually parent or guardian) must have a level of understanding sufficient to provide written informed consent to all required tests and procedures.
  7. As required by the local or central IRB, the patient should assent to all required tests and procedures.

Exclusion Criteria:

  1. Patients who experienced a serious adverse event during the double-blind SOFIA Study which was determined to be related to the study medication by the Investigator or the sponsor
  2. Patients who were unable to tolerate the lowest dose of study medication in the double-blind SOFIA study (2mg fluoxetine or placebo) should not be enrolled in this study
  3. Diagnosis of Rett Syndrome, Childhood Disintegrative Disorder
  4. Patients currently taking psychotropic medication are excluded. Patients can be enrolled in the study if the psychotropic medication has been completely withdrawn prior to the baseline visit; for at least two weeks for neuroleptics / atypical antipsychotics and for at least 5 days for stimulants
  5. Patients exhibiting high levels of aggression, irritability or self injurious behavior to the extent that in the Investigator's opinion the patient would be more appropriately treated with psychotropic medication other than fluoxetine such as an atypical antipsychotic
  6. Patients currently taking a monoamine oxidase inhibitor. Patients who have stopped taking an irreversible MAOI should be free of medication for at least 2 weeks prior to the baseline visit and medication free for at least one day after stopping a reversible MAOI A.
  7. Patients with diabetes who are treated with insulin
  8. Patients currently taking tramadol, triptans (e.g.sumatriptan), lithium, tryptophan, haloperidol, clozapine, flecainide or encainide, vinblastine, carbamazepine, tricyclic antidepressants, phenytoin or warfarin are also excluded from the study.
  9. Current treatment with the herbal remedy, St John's Wort (Hypericum perforatum)
  10. History of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
  11. History of, or current cerebrovascular disease or brain trauma.
  12. History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
  13. History of or current malignancy.
  14. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
  15. Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.
  16. Current active seizure disorder
  17. Tourette's Disorder.
  18. Female patients who are either pregnant or nursing.
  19. Documented history of hypersensitivity or intolerance to SSRIs
  20. Current drug abuse or dependence disorder or dependency in the 3 months prior to the baseline visit.
  21. Clinically significant abnormalities in safety laboratory tests or vital signs as measured at baseline (as applicable) that would put the patient at substantially increased risk from study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787111

Locations
United States, Arizona
Southwest Autism Research and Resource Centre
Phoenix, Arizona, United States, 85006
United States, California
University of California Davis
Sacramento, California, United States, 95817
United States, Georgia
Institute for Behavioral Medicine
Smyrna, Georgia, United States, 30080
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60637-1448
AMR-Baber Research Inc.
Naperville, Illinois, United States, 60563
United States, Massachusetts
Harvard Medical School
Medford, Massachusetts, United States, 02155
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
CRCNJ
Voorhees, New Jersey, United States, 08043
United States, New York
Long Island Jewish Hospital
Bethpage, New York, United States, 11714
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Washington
Seattle Children's Hosptial University of Washington
Seattle, Washington, United States, 98105-0371
Sponsors and Collaborators
Neuropharm
Autism Speaks
  More Information

No publications provided

Responsible Party: Dr. Mike Snape/ Chief Scientific Officer, Neuropharm
ClinicalTrials.gov Identifier: NCT00787111     History of Changes
Other Study ID Numbers: NPL-2008-4-AUTUS-005
Study First Received: November 5, 2008
Last Updated: February 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuropharm:
Drug: Fluoxetine

Additional relevant MeSH terms:
Autistic Disorder
Disease
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014