Clinical trial NCT00965419: A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
Official title: Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 267
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study
timeFrame: Baseline Through Week 252
measure: Number of Participants With At Least One SAE
timeFrame: Baseline Through Week 252
Secondary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline Through Week 252
measure: Number of Participants With At Least One TEAE
timeFrame: Baseline Through Week 252
measure: Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)
timeFrame: Baseline Through Week 252
measure: Number of Participants With At Least One DCAEs
timeFrame: Baseline Through Week 252
measure: Percentage of Participants Who Discontinued Due to Any Reason
timeFrame: Baseline Through Week 252
measure: Number of Participants Who Discontinued Due to Any Reason
timeFrame: Baseline Through Week 252
measure: Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
timeFrame: Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)
measure: Mean Change From Baseline Z-scores for Height
timeFrame: Baseline, Week 60; Baseline, Week 240
measure: Mean Change From Baseline Z-Score for Weight
timeFrame: Baseline, Week 60; Baseline, Week 240
measure: Mean Change From Baseline Z-Score in Body Mass Index (BMI)
timeFrame: Baseline, Week 60; Baseline, Week 240
measure: Percentage of Participants With Response Rates
timeFrame: Week 12
measure: Number of Participants With a Response Rate
timeFrame: Week 12
measure: Survival Curve Time to Response
timeFrame: Week 12
measure: Percentage of Participants in Sexual Maturation on Tanners Scale
timeFrame: Baseline Up to Week 252
measure: Number of Participants in Sexual Maturation on Tanners Scale
timeFrame: Baseline Up to Week 252
measure: Percentage of Participants With Tobacco, Alcohol and Marijuana Use
timeFrame: Week 60 through Week 252
measure: Number of Participants With Tobacco, Alcohol and Marijuana Use
timeFrame: Week 60 through Week 252
measure: Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode
timeFrame: Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
measure: Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
measure: Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Total Score EQ-5D-3L VAS
timeFrame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
measure: Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])
timeFrame: Baseline, Week 60
measure: Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
timeFrame: Baseline, Week 60
measure: Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
timeFrame: Baseline, Week 60
measure: Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
timeFrame: Baseline, Week 60
Other outcomes:
Locations:
city: Spring Valley
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Gainesville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Orlando
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: University Park
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Smyrna
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Georgia
city: Libertyville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
city: Rochester Hills
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Michigan
city: Omaha
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nebraska
city: Las Vegas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nevada
city: Philadelphia
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Pennsylvania
city: Memphis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tennessee
city: Lake Jackson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
city: Lubbock
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
city: Herndon
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Virginia
city: Seattle
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Washington
city: Kelowna
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: British Columbia
city: Santurce
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kuei Shan Hsiang
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: