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Autistic DisorderPhase 3EMMANCT00787111

Extended Management and Measurement of Autism

A Phase 3 study testing Fluoxetine (prozac) in people with Autistic Disorder, run by Neuropharm at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Autistic Disorder
What is being tested?
Fluoxetine (prozac)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
13 sitesUnited States
Study dates
Nov 2008to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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double-blind SOFIA Study, and must have completed at least 10 weeks of treatment in the 14 week SOFIA study or have withdrawn from the SOFIA study due to worsening of clinical symptoms (i.e. a CGI-I-AD of 6 or 7 which, in the Investigator's opinion, required alternative intervention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).
  • Patients must have been free of fluoxetine and other SSRI's for 4 weeks prior to the first dose of open-label medication (washout).
  • Female patients who have reached menarche must have a negative pregnancy test at baseline and as required, in the opinion of the Investigator.
  • 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.
  • Patients must be able to follow the Investigator's instructions and be able to comply with visit requirements
  • 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.
  • As required by the local or central IRB, the patient should assent to all required tests and procedures.

Who cannot join

  • 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
  • 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
  • Diagnosis of Rett Syndrome, Childhood Disintegrative Disorder
  • 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
  • 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
  • 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.
Show all 21Show fewer
  • Patients with diabetes who are treated with insulin
  • 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.
  • Current treatment with the herbal remedy, St John's Wort (Hypericum perforatum)
  • 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.
  • History of, or current cerebrovascular disease or brain trauma.
  • History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
  • History of or current malignancy.
  • Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
  • Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.
  • Current active seizure disorder
  • Tourette's Disorder.
  • Female patients who are either pregnant or nursing.
  • Documented history of hypersensitivity or intolerance to SSRIs
  • Current drug abuse or dependence disorder or dependency in the 3 months prior to the baseline visit.
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Long Island Jewish Hospital

    Bethpage, New York, 11714

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • University of Illinois

    Chicago, Illinois, 60637-1448

  • Ohio State University

    Columbus, Ohio, 43210

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Harvard Medical School

    Medford, Massachusetts, 02155

  • AMR-Baber Research Inc.

    Naperville, Illinois, 60563

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Southwest Autism Research and Resource Centre

    Phoenix, Arizona, 85006

  • University of California Davis

    Sacramento, California, 95817

  • Seattle Children's Hosptial University of Washington

    Seattle, Washington, 98105-0371

  • Institute for Behavioral Medicine

    Smyrna, Georgia, 30080

  • CRCNJ

    Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Fluoxetine (prozac)
Keywords
Drug: Fluoxetine
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoxetine (prozac)Drug

    Formulation: ODT

Study groups in NCT00787111
Study groupRoleWhat they receive
Fluoxetine ODTExperimentalFluoxetine ODT ranging from 2mg to 54mg
Receives: Drug: Fluoxetine (prozac)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: through the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00787111
Sponsor's protocol ID
NPL-2008-4-AUTUS-005
Acronym
EMMA
Status last verified
Feb 2010
First submitted
5 Nov 2008
Last updated
23 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluoxetine (prozac) in people with Autistic Disorder, run by Neuropharm at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00787111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.

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