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

February 25, 2022 updated by: Shire

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Baseline and 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks
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.
7 weeks
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.
7 weeks
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.
Baseline and 7 weeks
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.
Baseline and 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

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Drug Interventions

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