Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT00735371
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study testing LDX 30 mg, LDX 50 mg and LDX 70 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 45 sites in United States.
Trial summary
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- LDX 30 mg, LDX 50 mg and LDX 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 45 sitesUnited States
- Study dates
- 8 Oct 2008to 6 Apr 2009
- Phase
- Phase 3
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >=28
- BP w/in 95th percentile for age, gender, and height
Who cannot join
- Subject has controlled or uncontrolled comorbid psychiatric diagnosis
- Subject has conduct disorder
- Suicidal
- Under or overweight
- Concurrent chronic or acute illness that might confound results.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
FutureSearch Trials
Austin, Texas, 78756
Northwest Clinical Research Center
Bellevue, Washington, 98004
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Vermont Clinical Study Center
Burlington, Vermont, 05401
University Hospitals of Cleveland Division of Child Adolescent Psychiatry
Cleveland, Ohio, 44106
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, 27707
Valley Clinical Research, Inc.
El Centro, California, 92243
OCCI
Eugene, Oregon, 97401
Innovis Health/Odyssey Research
Fargo, North Dakota, 58104
Sarkis Clinical Trials
Gainesville, Florida, 32607
Neuroscience, Inc
Herndon, Virginia, 20170
Amedica Research Institute, Inc.
Hialeah, Florida, 33013
Bayou City Research, Ltd
Houston, Texas, 77007
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Center for Psychiatry and Behavioral Medicine, Inc
Las Vegas, Nevada, 89128
Capstone Clinical Research
Libertyville, Illinois, 60048
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Valerie Arnold
Memphis, Tennessee, 38119
Dominion Clinical Research
Midlothian, Virginia, 23112
Bioscience Research, LLC
Mount Kisco, New York, 10549
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114
Cientifica, Inc at Prairie View
Newton, Kansas, 67114
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806-1122
Psychiatric Associates
Overland Park, Kansas, 66211
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
Pedia Research, LLC
Owensboro, Kentucky, 42301
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Youth and Family Research Program/WP IC ADHD Research Program
Pittsburgh, Pennsylvania, 15213
Summit Research Network
Portland, Oregon, 97210
Peninsula Research Associates, Inc
Rolling Hills Estates, California, 90274
OCCI Inc
Salem, Oregon, 97301
ADHD Clinic of San Antonio
San Antonio, Texas, 78247
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
San Diego, California, 92108
Miami Research Associates
South Miami, Florida, 33143
Clinco Inc.
Terre Haute, Indiana, 47802
Children's Specialized Hospital
Toms River, New Jersey, 08755
Bart Sangal, MD
Troy, Michigan, 48085
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Elite Clinical Trials, Inc
Wildomar, California, 92595
Neuropsychiatric Associates
Woodstock, Vermont, 05091
About this study
Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
- Being tested
- LDX 30 mg, LDX 50 mg, LDX 70 mg, Placebo
- 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.
LDX 30 mgDrug
Also called Vyvanse
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
LDX 50 mgDrug
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
LDX 70 mgDrug
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
PlaceboDrug
Placebo will be identical to test product.
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) 30 mg | Active comparator | Not described Receives: Drug: LDX 30 mg |
| LDX 50 mg | Active comparator | Not described Receives: Drug: LDX 50 mg |
| LDX 70 mg | Active comparator | Not described Receives: Drug: LDX 70 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
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 and 4 weeks
Secondary outcomes (2)
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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 (very much improved) or 2 (much improved) on the scale.
Measured: 1, 2, 3 and 4 Weeks
Youth Quality of Life-Research Version (YQOL-R) Total Score
The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study start8 Oct 2008
- Primary completion6 Apr 2009
- Study completion6 Apr 2009
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 (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 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
- NCT00735371
- Sponsor's protocol ID
- SPD489-305
- Status last verified
- Jun 2021
- First submitted
- 12 Aug 2008
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.
PubMed 21421179
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00735371
- Acronym / sponsor ID
- SPD489-305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2008 (actual)
- Primary completion
- 6 Apr 2009 (actual)
- Study completion
- 6 Apr 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 23 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) 30 mg | Active comparator | Drug: LDX 30 mg |
| LDX 50 mg | Active comparator | Drug: LDX 50 mg |
| LDX 70 mg | Active comparator | Drug: LDX 70 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >=28
- BP w/in 95th percentile for age, gender, and height
Key exclusion criteria (5 listed)
- Subject has controlled or uncontrolled comorbid psychiatric diagnosis
- Subject has conduct disorder
- Suicidal
- Under or overweight
- Concurrent chronic or acute illness that might confound results.
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 |
|---|---|---|
| LDX 30 mgAlso: VyvanseEligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. | Drug | Lisdexamfetamine Dimesylate (LDX) 30 mg |
| LDX 50 mgEligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. | Drug | LDX 50 mg |
| LDX 70 mgEligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. | Drug | LDX 70 mg |
| PlaceboPlacebo will be identical to test product. | Drug | Placebo |
Primary outcome
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
Time frame: Baseline and 1, 2, 3 and 4 weeks
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 secondary outcomes
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Time frame: 1, 2, 3 and 4 Weeks
Youth Quality of Life-Research Version (YQOL-R) Total Score
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21421179Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.
- 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
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LDX 30 mg, LDX 50 mg and LDX 70 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 45 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 3 inclusion and 5 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Feb 2010). 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 Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks (time frame: Baseline and 1, 2, 3 and 4 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 NCT00735371, which also lists 1 linked publication.
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 14 Jun 2021.