Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
NCT ID: NCT00764868
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2008-11-13
2010-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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LDX
Lisdexamfetamine Dimesylate (LDX)
Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily
Interventions
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Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion
1. 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).
2. 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).
3. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
10. Subject has any clinically significant ECG, based on the Principal Investigator's judgment, at Visit 4/ET of the antecedent study (SPD489-305).
11. Subject is taking any medication that is excluded.
12. Subject has a documented allergy, hypersensitivity or intolerance to amphetamine.
13. 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.
14. Subject has glaucoma.
15. 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.
16. Subject is female and is pregnant or lactating.
13 Years
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
El Centro, California, United States
Penninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
San Diego, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Amedica Research Institute, Inc.
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Clinco Inc.
Terre Haute, Indiana, United States
CIENTIFICA, Inc. at Prairie View
Newton, Kansas, United States
Psychiatric Associates
Overland Park, Kansas, United States
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Pedia Research LLC.
Owensboro, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Bart Sangal
Troy, Michigan, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Children's Specialized Hospital
Toms River, New Jersey, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, United States
Innovis Health/Odyssey Research
Fargo, North Dakota, United States
University Hospitals of Cleveland Division of Child & Adolescent Psychiatry
Cleveland, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
OCCI
Eugene, Oregon, United States
Summit Research Network
Portland, Oregon, United States
OCCI, INC (Oregon Center for Clinical Investigations, Inc.)
Salem, Oregon, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Youth and Family Research Program/WPIC ADHD Research Program
Pittsburgh, Pennsylvania, United States
CNS Healthcare
Memphis, Tennessee, United States
Future Search Trials
Austin, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Red Oak Psychiatry Associates P.A.
Houston, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
Vermont Clinical Study Center
Burlington, Vermont, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Neuroscience, Inc.
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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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.
Other Identifiers
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SPD489-306
Identifier Type: -
Identifier Source: org_study_id
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