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A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder
This study is currently recruiting participants.
Verified May 2012 by Eli Lilly and Company

First Received on August 24, 2009.   Last Updated on May 18, 2012   History of Changes
Sponsor: Eli Lilly and Company
Information provided by (Responsible Party): Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00965419
  Purpose

The primary purpose of your child's participation in the study is to determine whether LY2216684 can help pediatric patients with ADHD, and assess the safety of LY2216684 and any side effects that might be associated with it.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: LY2216684
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Serious Adverse Events (SAE) of LY2216684; percentage [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events (SAE) of LY2216684; number [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment-emergent adverse events (TEAEs); percentage [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Discontinuation due to adverse events (DCAEs); percentage [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Discontinuation rates; percentage [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (CSSRS); incident rate for each category [ Time Frame: week 0, week 12, year 1, year 5, 1-month follow-up ] [ Designated as safety issue: Yes ]
  • Conners Comprehensive Behavior Rating Scales (CP-CBRS) DSM-IV-TR symptom subscale for manic episode and mixed episode; mean change of total score [ Time Frame: week 0, week 12, year 1, year 5, 1-month follow-up ] [ Designated as safety issue: Yes ]
  • Tanners scale - height, weight, BMI; Z-score change [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: Yes ]
  • Tanners scale - sexual maturation; percentage [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: Yes ]
  • Tobacco, alcohol and marijuana use; percentage [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (hyperactive/impulsive, inattentive and total score); mean change of each score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S); mean change of total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Conners Comprehensive Behavior Rating Scales (CP-CBRS DSM-IV-TR) ADHD symptom subscales (hyperactive/impulsive, inattentive and total score); mean change of each score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD subscales (hyperactive/impulsive, inattentive and total score); mean change of total score [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Response rate; percentage [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Time to response; survival curve [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) oppositional defiant disorder (ODD) subscale; mean change of total score [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Conners Comprehensive Behavior Rating Scales (CP-CBRS) DSM-IV-TR for oppositional defiant disorder (ODD), anxiety, conduct disorder and major depressive episode; mean change of each score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Adolescent edition (CHIP-AE) in 5 health outcome domains (satisfaction, comfort, resilience, risk avoidance and achievement); mean change of the 5 domain scores [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Child edition (CHIP-CE) in 5 health outcome domains (satisfaction, comfort, resilience, risk avoidance and achievement); mean change of the 5 domain scores [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Conners Comprehensive Behavior Rating Scales (CP-CBRS) impairment items subscales for schoolwork/grades, friendship/relationships, and home life; mean change of total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Conners Comprehensive Behavior Rating Scales (CP-CBRS) content subscale for aggressive behaviors, academic difficulties (total/language/,math), social problems, and violence potential), mean change of each total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Euro-Qol Questionnaire - 5 Dimensions (EQ-5D) for parent, mean change of total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Euro-Qol Questionnaire - 5 Dimensions (EQ-5D) for child, mean change of total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Euro-Qol Questionnaire - 5 Dimensions (EQ-5D) for adolescent, mean change of total score [ Time Frame: week 0, week 12, year 1, year 5 ] [ Designated as safety issue: No ]
  • Woodcock Johnson III Test of Achievement (WCJ III ACH), mean change of total score [ Time Frame: week 0, year 1 year 5 ] [ Designated as safety issue: No ]
  • Wide Range Achievement Test (WRAT-IV or WRAT4); mean change of total score [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV); mean change of total score [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: No ]
  • Wechsler Adult Intelligence Scale - third Edition (WAIS-III); mean change of total score [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: No ]
  • Treatment-emergent adverse events (TEAEs); number [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Discontinuation due to adverse events (DCAEs); number [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Discontinuation rates; number [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Tanners scale - sexual maturation; number [ Time Frame: week 0, year 1, year 5 ] [ Designated as safety issue: Yes ]
  • Tobacco, alcohol and marijuana use; number [ Time Frame: week 0 thru 5 years ] [ Designated as safety issue: Yes ]
  • Response rate; number [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: August 2009
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684 Drug: LY2216684
0.1 mg/kg/day or patient specific known stable dose (rollover patients) up to 0.3 mg/kg/day, oral, daily for up to 5 years.

Detailed Description:

12 week dose titration and response assessment period. One (1) year open label treatment for responders. Long-term extension of up to 4 additional years for responders.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Patients must meet Diagnostic & Statistical Manual of Mental Disorders 4th Ed diagnostic criteria for ADHD based Kiddie Schedule for Affective Disorders & Schizophrenia for School Aged Children - Present and Lifetime Version at screening for new patients/rollover patients.
  • Patients 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 patients must have a CGI-ADHD-S score greater than or equal to 4 at both screening/randomization.
  • Patients 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 patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test.
  • Patients must have laboratory results, showing no clinically significant abnormalities.
  • Parents/patients must have a degree of understanding sufficient to communicate suitably with the investigator/ study coordinator.
  • Patients must be of normal intelligence.
  • Patients/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.
  • Patients must be able to swallow tablets.

EXCLUSION CRITERIA:

  • Patients who weigh less than 16 kg at screening/randomization.
  • Female patients who are pregnant/breastfeeding.
  • Patients who have previously withdrawn/discontinued early from this study or any other study investigating LY2216684.
  • Patients who have a history of Bipolar I/II disorder, psychosis, or pervasive developmental disorder.
  • Patients with a history of any seizure disorder or known electroencephalographic (EEG) abnormalities in the absence of seizures.
  • Patients who are at serious suicidal risk.
  • Patients with a history of severe allergies to more than 1 class of medications, or multiple adverse drug reactions, or known hypersensitivity to LY2216684.
  • Patients 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.
  • Patients who screen positive for drugs of abuse cannot participate.
  • Patients 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.
  • Patients with problems that would be exacerbated by increased norepinephrine tone including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or urinary retention.
  • Patients who at any time during the study are likely to need psychotropic medications apart from the drugs under study.
  • Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization.
  • Patients with current or past history of clinically significant hypertension.
  • Patients 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.
  • Patients 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.
  • Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965419

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559

  Show 24 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00965419     History of Changes
Other Study ID Numbers: 11332, H9P-MC-LNDH
Study First Received: August 24, 2009
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ethics Committee
Mexico: Ministry of Health
Taiwan: Department of Health
Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 24, 2012



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