Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
NCT ID: NCT00500071
Last Updated: 2022-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
318 participants
INTERVENTIONAL
2007-06-28
2008-01-02
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
TREATMENT
NONE
Study Groups
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1
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
12 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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Melmed Center
Scottsdale, Arizona, United States
Valley Clinical Research
El Centro, California, United States
Peninsula Research Assoc, Inc
Rolling Hills Estates, California, United States
UCSF-Langely Porter Psych Institute
San Francisco, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Shire Clinical Research Site
Wildomar, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Shire Clinical Research Site
Hialeah, Florida, United States
CNS Research Institute, Inc
Jacksonville, Florida, United States
CORE Research, Inc
Maitland, Florida, United States
Miami Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Children's Development Center
Winter Park, Florida, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Shire Clinical Research Site
Terre Haute, Indiana, United States
Shire Clinical Research Site
Newton, Kansas, United States
Psychiatric Associates
Overland Park, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Shire Clinical Research Site
Lexington, Kentucky, United States
Pedia Research
Owensboro, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Shire Clinical Research Site
Troy, Michigan, United States
University of Rochester, School of Medicine and Dentistry
Rochester, New York, United States
Piedmont Neuropsychiatry
Charlotte, North Carolina, United States
University Commons Office Park
Durham, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
BHI, Inc.
Moore, Oklahoma, United States
Shire Clinical Research Site
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc
Eugene, Oregon, United States
Oregon Center For Clinical Investigations, Inc.
Portland, Oregon, United States
Summit Research Network
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States
ADHD Program, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
The Jackson Clinic
Jackson, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn-Lesem Research Clinic Inc.
Bellaire, Texas, United States
Red Oak Psychiatry Associates P.A.
Houston, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
NeuroScience, Inc
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
International Clinical Research Associates, LLC
Richmond, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Countries
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References
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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.
Katic 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.
Turgay 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.
Related Links
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FDA recall information
Other Identifiers
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SPD489-310
Identifier Type: -
Identifier Source: org_study_id
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