A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00922636
First received: June 16, 2009
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The primary purpose of your child's participation in this 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
Drug: Methylphenidate
Drug: Placebo (tablet)
Drug: Placebo (capsule)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Swanson Nolan, and Pelham (SNAP) ADHD - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) academic difficulties - total/language/math subscale- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Improvement (CGI-ADHD-I)- endpoint score [ Time Frame: week 1, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) symptom subscales - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Swanson Nolan, and Pelham (SNAP-IV) oppositional defiant disorder (ODD) subscale; Teacher rated - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) impairment items subscale- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C-SSRS)- incident rate for each category [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for manic episode - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) content subscales - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Adolescent edition (CHIP-AE) - mean change of each domain scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Child edition (CHIP-CE) - mean change of each domain scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing - change from baseline [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Rapid Automatized Naming/ Rapid Alternating Stimulus Test (RAN/RAS)- mean change of each subtotal score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for ODD - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for anxiety- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for conduct disorder - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for major depressive episode- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of a.m. total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of p.m. total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for mixed episode- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of subtotal scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span - mean change of subtotal scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate Drug: Methylphenidate
Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, given once daily and orally as a capsule for 10 weeks.
Placebo Comparator: Placebo Drug: Placebo (tablet)
Placebo given once daily and orally for 10 weeks as a tablet for LY2416684 blind.
Drug: Placebo (capsule)
Placebo given once daily and orally for 10 weeks as a capsule for methylphenidate blind.
Experimental: LY2216684 (0.1 mg/kg/day) Drug: LY2216684
Taken by mouth once daily for 10 weeks.
Experimental: LY2216684 (0.2 mg/kg/day) Drug: LY2216684
Taken by mouth once daily for 10 weeks.
Experimental: LY2216684 (0.3 mg/kg/day) Drug: LY2216684
Taken by mouth once daily for 10 weeks.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet DSM-IV diagnostic criteria for ADHD based on K-SADS-PL prior to randomization.
  • Patients must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age/gender norm prior to randomization. They must have a CGI-ADHD-S score greater than or equal to 4 at both the patients screening visit, prior to randomization.
  • Patients must have laboratory results; showing no clinically significant abnormalities.
  • Patients must be of normal intelligence, as assessed by the investigator.
  • Patients/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venous punctures and examinations required by the protocol.
  • 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.

Exclusion Criteria:

  • Patients who weigh less than 18 kg or greater than 75 kg at screening and at randomization.
  • Female patients who are pregnant or who are breast-feeding. Patients who have a history of Bipolar I/ II, psychosis, or pervasive developmental disorder.
  • Patients who have current motor tics or a diagnosis of Tourette's Syndrome.
  • Patients with marked anxiety, tension, and agitation sufficient, to contraindicate treatment with extended-release methylphenidate.
  • Patients with a history of any seizure disorder, known electroencephalographic (EEG) abnormalities in the absence of seizures.
  • If the ECG assessed at screening/prior to randomization shows an abnormality meeting one or more of the absolute exclusion criteria listed in the Pediatric ECG Alert Criteria must be excluded from the study.
  • Patients who, in the opinion of the investigator, are at serious suicidal risk.
  • Patients with a history of severe allergies to more than one class of medications, multiple adverse drug reactions, or known hypersensitivity to extended-release methylphenidate.
  • Patients with a history of alcohol or drug abuse within the past 3 months prior to, 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.
  • Patients who screen positive for drugs of abuse not prescribed by a physician cannot participate. Drug screen may be repeated at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study.
  • 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. Such medications can be taken on an as-needed basis.
  • Patients with problems that would be exacerbated by increased norepinephrine tone, including a history of cardiovascular disease, thyroid dysfunction, glaucoma, urinary retention, or severe gastrointestinal narrowing.
  • Patients who, at any time during the study, are likely to need psychotropic medications apart from the drugs under study.
  • Patients who, at any time during the study, are likely to begin structured psychotherapy aimed at ADHD symptoms are excluded. Psychotherapy initiated at least 1 month prior to screening is acceptable.
  • 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.
  • Patients who have participated in a prior study of LY2216684.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922636

Locations
United States, California
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.
Spring Valley, California, United States, 91978
United States, Florida
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.
Bradenton, Florida, United States, 34208
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.
Gainesville, Florida, United States, 32607
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.
Orlando, Florida, United States, 32806
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Nebraska
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.
Lincoln, Nebraska, United States, 68510
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.
Omaha, Nebraska, United States, 68198
United States, Nevada
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.
Las Vegas, Nevada, United States, 89128
United States, Ohio
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.
Canton, Ohio, United States, 44718
United States, Oregon
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.
Portland, Oregon, United States, 97210
United States, Pennsylvania
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.
Media, Pennsylvania, United States, 19063
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.
Norristown, Pennsylvania, United States, 19401
United States, Tennessee
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.
Memphis, Tennessee, United States, 38119
United States, Texas
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.
Lake Jackson, Texas, United States, 77566
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.
Lubbock, Texas, United States, 79423
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.
Wharton, Texas, United States, 77488
United States, Virginia
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.
Herndon, Virginia, United States, 20170
Canada, British Columbia
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.
Kelowna, British Columbia, Canada, V1Y 1Z9
Puerto Rico
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.
Santurce, Puerto Rico, 00912
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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00922636     History of Changes
Other Study ID Numbers: 10925, H9P-MC-LNBF
Study First Received: June 16, 2009
Last Updated: January 24, 2011
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
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014