Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: Vyvanse (lisdexamfetamine dimesylate)

Detailed Description

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Melmed Center
  • California
    • El Centro, California, United States
      • Valley Clinical Research
    • Rolling Hills Estates, California, United States
      • Peninsula Research Assoc, Inc
    • San Francisco, California, United States
      • UCSF-Langely Porter Psych Institute
    • Spring Valley, California, United States
      • Encompass Clinical Research
    • Wildomar, California, United States
      • Shire Clinical Research Site
  • Florida
    • Gainesville, Florida, United States
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States
      • Shire Clinical Research Site
    • Jacksonville, Florida, United States
      • CNS Research Institute, Inc
    • Maitland, Florida, United States
      • CORE Research, Inc
    • Miami, Florida, United States
      • Miami Research Associates
    • Orlando, Florida, United States
      • Clinical Neuroscience Solutions, Inc
    • West Palm Beach, Florida, United States
      • Janus Center For Psychiatric Research
    • Winter Park, Florida, United States
      • Children's Development Center
  • Illinois
    • Libertyville, Illinois, United States
      • Capstone Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States
      • Indiana University School of Medicine
    • Terre Haute, Indiana, United States
      • Shire Clinical Research Site
  • Kansas
    • Newton, Kansas, United States
      • Shire Clinical Research Site
    • Overland Park, Kansas, United States
      • Psychiatric Associates
  • Kentucky
    • Bardstown, Kentucky, United States
      • Kentucky Pediatric/Adult Research
    • Lexington, Kentucky, United States
      • Shire Clinical Research Site
    • Owensboro, Kentucky, United States
      • Pedia Research
    • Paducah, Kentucky, United States
      • Four Rivers Clinical Research, Inc.
  • Michigan
    • Troy, Michigan, United States
      • Shire Clinical Research Site
  • New York
    • Rochester, New York, United States
      • University of Rochester, School of Medicine and Dentistry
  • North Carolina
    • Charlotte, North Carolina, United States
      • Piedmont Neuropsychiatry
    • Durham, North Carolina, United States
      • University Commons Office Park
  • Ohio
    • Cleveland, Ohio, United States
      • University Hospitals Of Cleveland
  • Oklahoma
    • Moore, Oklahoma, United States
      • BHI, Inc.
    • Oklahoma City, Oklahoma, United States
      • Shire Clinical Research Site
  • Oregon
    • Eugene, Oregon, United States
      • Oregon Center for Clinical Investigations, Inc
    • Portland, Oregon, United States
      • Oregon Center for Clinical Investigations, Inc.
    • Portland, Oregon, United States
      • Summit Research Network
    • Salem, Oregon, United States
      • Oregon Center for Clinical Investigations, Inc.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • ADHD Program, Western Psychiatric Institute and Clinic
  • Tennessee
    • Jackson, Tennessee, United States
      • The Jackson Clinic
    • Memphis, Tennessee, United States
      • Clinical Neuroscience Solutions, Inc
  • Texas
    • Austin, Texas, United States
      • FutureSearch Trials
    • Bellaire, Texas, United States
      • Claghorn-Lesem Research Clinic Inc.
    • Houston, Texas, United States
      • Red Oak Psychiatry Associates P.A.
    • Lake Jackson, Texas, United States
      • R/D Clinical Research, Inc.
    • San Antonio, Texas, United States
      • ADHD Clinic of San Antonio
  • Virginia
    • Herndon, Virginia, United States
      • Neuroscience, Inc
    • Midlothian, Virginia, United States
      • Dominion Clinical Research
    • Richmond, Virginia, United States
      • International Clinical Research Associates, LLC
  • Washington
    • Kirkland, Washington, United States
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
3. primary diagnosis of ADHD based on a detailed psychiatric evaluation.
4. Subjects must have a baseline ADHD-RS-IV total score ≥28.
5. Subject is functioning at an age-appropriate level intellectually.
6. comply with all the testing and requirements.
7. Subject is able to swallow a capsule.
8. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria

1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
2. Subject has Conduct Disorder.
3. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
6. Subject has a positive urine drug result.
7. Subject weighs less than 50 pounds (22.7kg).
8. Subject is significantly overweight.
9. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
10. Subject has any reported history of abnormal thyroid function.
11. Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
12. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments.
13. The female subject is pregnant or lactating.
14. Subject is well-controlled on their current ADHD medication with acceptable tolerability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Vyvanse (lisdexamfetamine dimesylate); Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks	Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.	Baseline and 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Change From Baseline in Total ADHD-RS-IV Score	Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.	Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.	7 weeks
Number of Participants With Improvement onParent Global Assessment (PGA)	Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	7 weeks
Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks	Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.	Baseline and 7 weeks
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks	Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.	Baseline and 7 weeks

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):649-62. doi: 10.1089/cap.2008.0165.
• Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Turgay A, Findling RL. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord. 2012 Jul;16(5):384-97. doi: 10.1177/1087054710389990. Epub 2010 Dec 20.
• Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Findling RL. Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):503-11. doi: 10.1089/cap.2009.0110.

Helpful Links

• FDA Recall Information
• FDA-approved Label

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2007
• Primary Completion (Actual): January 2, 2008
• Study Completion (Actual): January 2, 2008

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 12, 2007

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No