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

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ClinicalTrials.gov Identifier: NCT00500071
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : September 1, 2009
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Drug: Vyvanse (lisdexamfetamine dimesylate) Phase 4

Detailed Description:
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 28, 2007
Actual Primary Completion Date : January 2, 2008
Actual Study Completion Date : January 2, 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Weekly Change From Baseline in Total ADHD-RS-IV Score [ Time Frame: Baseline and 1, 2, 3, 4, 5, 6, and 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.

  2. Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 7 weeks ]
    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.

  3. Number of Participants With Improvement onParent Global Assessment (PGA) [ Time Frame: 7 weeks ]
    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.

  4. Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks [ Time Frame: Baseline and 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.

  5. Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks [ Time Frame: Baseline and 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500071


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00500071    
Other Study ID Numbers: SPD489-310
First Posted: July 12, 2007    Key Record Dates
Results First Posted: September 1, 2009
Last Update Posted: March 10, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
 Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents