A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder



Status:Terminated
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 18
Updated:4/29/2018
Start Date:September 2009
End Date:July 2015

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Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

The primary purpose of the study is to assess long-term safety and tolerability of
Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).


INCLUSION CRITERIA:

-Participants must meet Diagnostic and Statistical Manual of Mental Disorders 4th Ed
(DSM-IV) diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined
subtypes) based on an interview by an experienced clinician and confirmed using the Kiddie
Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present (SADS)
and Lifetime Version (K-SADS-PL) at Visit 1 for new participants and in the parent trial
for rollover participants.

-Participants must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard
deviations above the age/gender norm at both screening/randomization. New participants must
have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder- Severity
(CGI-ADHD-S) score greater than or equal to 4 at both screening/randomization.

- Participants of child-bearing potential agree to use a reliable method of birth
control during the study and for 1 month following the last dose of study drug. Female
participants of child-bearing potential must test negative for pregnancy at the time
of enrollment based on a urine pregnancy test.

- Participants must have laboratory results, showing no clinically significant
abnormalities.

- Parents/participants must have a degree of understanding sufficient to communicate
suitably with the investigator/ study coordinator.

- Participants must be of normal intelligence.

- Participants/parents must have been judged by the investigator to be reliable to keep
appointments for clinic visits/all tests, including venipunctures and examinations
required by the protocol.

- Participants must be able to swallow tablets.

EXCLUSION CRITERIA:

- Participants who weigh less than 16 kg at screening/randomization.

- Female participants who are pregnant/breastfeeding.

- Participants who have previously withdrawn/discontinued early from this study or any
other study investigating Edivoxetine.

- Participants who have a history of Bipolar I/II disorder, psychosis, or pervasive
developmental disorder.

- Participants with a history of any seizure disorder or known electroencephalographic
(EEG) abnormalities in the absence of seizures.

- Participants who are at serious suicidal risk.

- Participants with a history of severe allergies to more than 1 class of medications,
or multiple adverse drug reactions, or known hypersensitivity to Edivoxetine.

- Participants with a history of alcohol or drug abuse/dependence within the past 3
months of screening, or who are currently using alcohol, drugs of abuse, or any
prescribed or over-the-counter medication in a manner that the investigator considers
indicative of abuse/dependence.

- Participants who screen positive for drugs of abuse cannot participate.

- Participants who have a medical condition that would increase sympathetic nervous
system activity markedly, or who are taking a medication on a daily basis that has
sympathomimetic activity are excluded.

- Participants with problems that would be exacerbated by increased norepinephrine tone
including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or
urinary retention.

- Participants who at any time during the study are likely to need psychotropic
medications apart from the drugs under study.

- Participants who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
prior to randomization.

- Participants with current or past history of clinically significant hypertension.

- Participants who are currently enrolled in, or discontinued within the last 30 days
from a clinical trial involving an off-label use of an investigational drug, or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study.

- Participants whose family anticipates a move outside the geographic range of the
investigative site during participation in the study or who plan extended travel
inconsistent with the recommended visit intervals.

- Participants who, in the opinion of the investigator, are unsuitable in any other way
to participate in this study.
We found this trial at
17
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Rochester Hills, Michigan 48085
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Spring Valley, California 91978
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