ADHDPhase 3NCT00764868

Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

A Phase 3 study testing Lisdexamfetamine Dimesylate (LDX) in people with ADHD, run by Shire at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent). Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: ADHD
What is being tested?: Lisdexamfetamine Dimesylate (LDX)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 269 participants
Where: 45 sitesUnited States
Study dates: 13 Nov 2008to 22 Apr 2010
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

Subject is a male or female aged 13-17 years inclusive at the time of consent of the antecedent study (SPD489-305).
Subject satisfied all entry criteria for the antecedent study (SPD489-305), and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events (AEs) that would preclude exposure to LDX.

Who cannot join

Subject was terminated from SPD489-305 for non-compliance and/or experienced a serious adverse event (SAE) or AE resulting in termination from the antecedent study (SPD489-305).
Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (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, such as agitated states, marked anxiety, or tension that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1) of the antecedent study (SPD489-305) with the Screening interview of the Kiddie-SADS-Present and Lifetime - Diagnostic Interview (K-SADS-PL) and additional modules if warranted by the results of the initial interview. Participation in behavioral therapy, provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-305).
Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
Subject is underweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at the Enrollment Visit (Visit 1) of this study. Underweight is defined as a BMI < 5th percentile.
Subject has a concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.

Show all 16Show fewer

Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
Subject has a known history symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG, based on the Principal Investigator's judgment, at Visit 4/ET of the antecedent study (SPD489-305).
Subject is taking any medication that is excluded.
Subject has a documented allergy, hypersensitivity or intolerance to amphetamine.
Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
Subject has glaucoma.
Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
Subject is female and is pregnant or lactating.

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Future Search 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 P.A.
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
CNS Healthcare
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
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/WPIC ADHD Research Program
Pittsburgh, Pennsylvania, 15213
Summit Research Network
Portland, Oregon, 97210
Penninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
OCCI, INC (Oregon Center for Clinical Investigations, 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
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

Other trials in United States

About this study

Official title: A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Read the detailed description

Not Required

Conditions: ADHD
Being tested: Lisdexamfetamine Dimesylate (LDX)
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.

Lisdexamfetamine Dimesylate (LDX)Drug
Also called Vyvanse
optimal dose of 30, 50 or 70 mg once daily

Study groups in NCT00764868
Study group	Role	What they receive
LDX	Experimental	Lisdexamfetamine Dimesylate (LDX) Receives: Drug: Lisdexamfetamine Dimesylate (LDX)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 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 up to 52 weeks

Secondary outcomes (2)

Percent of Participants With Improvement in 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 (very much improved) or 2 (much improved) on the scale.
Measured: up to 52 weeks
Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks
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 Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 200822 Apr 2010

First posted2 Oct 2008 (estimated)
Study start13 Nov 2008
Primary completion22 Apr 2010
Study completion22 Apr 2010

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 ADHDStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00764868
Sponsor's protocol ID: SPD489-306
Status last verified: Jun 2021
First submitted: 29 Sep 2008
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Childress AC. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):11-21. doi: 10.1089/cap.2011.0088.
PubMed 23410138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00764868
Acronym / sponsor ID: SPD489-306
Conditions: ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 13 Nov 2008 (actual)
Primary completion: 22 Apr 2010 (actual)
Study completion: 22 Apr 2010 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 28 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Not Required

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LDX	Experimental	Drug: Lisdexamfetamine Dimesylate (LDX)Lisdexamfetamine Dimesylate (LDX)

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Subject is a male or female aged 13-17 years inclusive at the time of consent of the antecedent study (SPD489-305).
Subject satisfied all entry criteria for the antecedent study (SPD489-305), and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events (AEs) that would preclude exposure to LDX.

Key exclusion criteria (16 listed)

Subject was terminated from SPD489-305 for non-compliance and/or experienced a serious adverse event (SAE) or AE resulting in termination from the antecedent study (SPD489-305).
Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (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, such as agitated states, marked anxiety, or tension that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1) of the antecedent study (SPD489-305) with the Screening interview of the Kiddie-SADS-Present and Lifetime - Diagnostic Interview (K-SADS-PL) and additional modules if warranted by the results of the initial interview. Participation in behavioral therapy, provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-305).
Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
Subject is underweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at the Enrollment Visit (Visit 1) of this study. Underweight is defined as a BMI < 5th percentile.

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
Lisdexamfetamine Dimesylate (LDX)Also: Vyvanseoptimal dose of 30, 50 or 70 mg once daily	Drug	LDX

Primary outcome

Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks
Time frame: Baseline and up to 52 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

Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
Time frame: up to 52 weeks
Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks
Time frame: Baseline and Up to 52 weeks

Results and safety

Results posted to the registry on 28 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lisdexamfetamine Dimesylate (LDX)	269	156

Primary outcome: Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks

Time frame: Baseline and up to 52 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Lisdexamfetamine Dimesylate (LDX) n = 265
Value	-26.2 (9.75)

Lisdexamfetamine Dimesylate (LDX): p <0.001, t-test, 2 sided

Population analysed: Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lisdexamfetamine Dimesylate (LDX)	10 of 265 (3.8%)	230 of 265 (86.8%)	Not reported

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 23410138Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Childress AC. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):11-21. doi: 10.1089/cap.2011.0088.

Related trials for ADHD

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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 Lisdexamfetamine Dimesylate (LDX) in people with 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 2 inclusion and 16 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. 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 28 Mar 2011). 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 (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks (time frame: Baseline and up to 52 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 NCT00764868, 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.