A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder

Lilly

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Edivoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965419

H9P-MC-LNDH (Other Identifier)

11332 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 267 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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267 participants in 1 patient group

Edivoxetine

Experimental group

Description:

All enrolled participants were administered starting dose of 0.1 milligram per kilogram per day (mg/kg/day), or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.

Treatment:

Drug: Edivoxetine