Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT00500071
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
A Phase 4 study testing Vyvanse (lisdexamfetamine dimesylate) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 46 sites in United States.
Trial summary
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Vyvanse (lisdexamfetamine dimesylate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 46 sitesUnited States
- Study dates
- 28 Jun 2007to 2 Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is a male or female aged 6-12 years inclusive at the time of consent.
- 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.
- primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subjects must have a baseline ADHD-RS-IV total score ≥28.
- Subject is functioning at an age-appropriate level intellectually.
- comply with all the testing and requirements.
- Subject is able to swallow a capsule.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
Who cannot join
- 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.
- Subject has Conduct Disorder.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
- Subject has a positive urine drug result.
Show all 14Show fewer
- Subject weighs less than 50 pounds (22.7kg).
- Subject is significantly overweight.
- Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has any reported history of abnormal thyroid function.
- Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
- 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.
- The female subject is pregnant or lactating.
- Subject is well-controlled on their current ADHD medication with acceptable tolerability.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
FutureSearch Trials
Austin, Texas
Kentucky Pediatric/Adult Research
Bardstown, Kentucky
Claghorn-Lesem Research Clinic Inc.
Bellaire, Texas
Piedmont Neuropsychiatry
Charlotte, North Carolina
University Hospitals of Cleveland
Cleveland, Ohio
University Commons Office Park
Durham, North Carolina
Valley Clinical Research
El Centro, California
Oregon Center for Clinical Investigations, Inc
Eugene, Oregon
Sarkis Clinical Trials
Gainesville, Florida
NeuroScience, Inc
Herndon, Virginia
Shire Clinical Research Site
Hialeah, Florida
Red Oak Psychiatry Associates P.A.
Houston, Texas
Indiana University School of Medicine
Indianapolis, Indiana
The Jackson Clinic
Jackson, Tennessee
CNS Research Institute, Inc
Jacksonville, Florida
Eastside Therapeutic Resource
Kirkland, Washington
R/D Clinical Research, Inc.
Lake Jackson, Texas
Shire Clinical Research Site
Lexington, Kentucky
Capstone Clinical Research
Libertyville, Illinois
CORE Research, Inc
Maitland, Florida
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee
Miami Research Associates
Miami, Florida
Dominion Clinical Research
Midlothian, Virginia
BHI, Inc.
Moore, Oklahoma
Shire Clinical Research Site
Newton, Kansas
Shire Clinical Research Site
Oklahoma City, Oklahoma
Clinical Neuroscience Solutions, Inc
Orlando, Florida
Psychiatric Associates
Overland Park, Kansas
Pedia Research
Owensboro, Kentucky
Four Rivers Clinical Research, Inc.
Paducah, Kentucky
ADHD Program, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania
Oregon Center For Clinical Investigations, Inc.
Portland, Oregon
Summit Research Network
Portland, Oregon
International Clinical Research Associates, LLC
Richmond, Virginia
University of Rochester, School of Medicine and Dentistry
Rochester, New York
Peninsula Research Assoc, Inc
Rolling Hills Estates, California
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon
ADHD Clinic of San Antonio
San Antonio, Texas
UCSF-Langely Porter Psych Institute
San Francisco, California
Melmed Center
Scottsdale, Arizona
Encompass Clinical Research
Spring Valley, California
Shire Clinical Research Site
Terre Haute, Indiana
Shire Clinical Research Site
Troy, Michigan
Janus Center for Psychiatric Research
West Palm Beach, Florida
Shire Clinical Research Site
Wildomar, California
Children's Development Center
Winter Park, Florida
About this study
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
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
Read the detailed description
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
- Being tested
- Vyvanse (lisdexamfetamine dimesylate)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vyvanse (lisdexamfetamine dimesylate)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Vyvanse (lisdexamfetamine dimesylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 7 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study start28 Jun 2007
- Primary completion2 Jan 2008
- Study completion2 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500071
- Sponsor's protocol ID
- SPD489-310
- Status last verified
- Feb 2022
- First submitted
- 10 Jul 2007
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 20035583Katic 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.
PubMed 21173426Turgay 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.
PubMed 21186969
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00500071
- Acronym / sponsor ID
- SPD489-310
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2007 (actual)
- Primary completion
- 2 Jan 2008 (actual)
- Study completion
- 2 Jan 2008 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 1 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vyvanse (lisdexamfetamine dimesylate) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subject is a male or female aged 6-12 years inclusive at the time of consent.
- 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.
- primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subjects must have a baseline ADHD-RS-IV total score ≥28.
- Subject is functioning at an age-appropriate level intellectually.
Key exclusion criteria (14 listed)
- 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.
- Subject has Conduct Disorder.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 1 |
Primary outcome
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.
5 secondary outcomes
Weekly Change From Baseline in Total ADHD-RS-IV Score
Time frame: 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
Number of Participants With Improvement onParent Global Assessment (PGA)
Time frame: 7 weeks
Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20035583Findling 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.
- Results publication: PubMed 21173426Katic 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.
- Results publication: PubMed 21186969Turgay 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.
- FDA recall informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vyvanse (lisdexamfetamine dimesylate) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500071, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.