Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00500071
First received: July 10, 2007
Last updated: January 14, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Vyvanse (lisdexamfetamine dimesylate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Weekly Change From Baseline in Total ADHD-RS-IV Score [ Time Frame: Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Improvement onParent Global Assessment (PGA) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 318
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00500071

  Show 46 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Robert L Finding, MD University Hospital Case Medical Center
  More Information

Additional Information:
Publications:
Katic A, Ginsberg L, Jain R, et al. Clinically Relevant Changes in Emotional Expression in Children With ADHD Treated With Lisdexamfetamine Dimesylate. Journal of Attention Disorders published online 20 December 2010.
Turgay A, Ginsberg L, Sarkis E, et al. Executive Function Defects in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study. Journal of Child and Adolescent Psychopharmacology, 20(6):503-511,2010.

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00500071     History of Changes
Other Study ID Numbers: SPD489-310
Study First Received: July 10, 2007
Results First Received: May 26, 2009
Last Updated: January 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dextroamphetamine
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014