Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
- Registration Number
- NCT00764868
- Lead Sponsor
- Shire
- Brief 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).
- Detailed Description
Not Required
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LDX Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate (LDX)
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) up to 52 weeks 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.
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 Baseline and 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.
Related Research Topics
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Trial Locations
- Locations (44)
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Vince and Associates Clinical Research, Inc.
🇺🇸Overland Park, Kansas, United States
Pedia Research LLC.
🇺🇸Owensboro, Kentucky, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
Bayou City Research, Ltd.
🇺🇸Houston, Texas, United States
Red Oak Psychiatry Associates P.A.
🇺🇸Houston, Texas, United States
OCCI
🇺🇸Eugene, Oregon, United States
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
🇺🇸San Diego, California, United States
ADHD Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Triangle Neuropsychiatry, PLLC
🇺🇸Durham, North Carolina, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Innovis Health/Odyssey Research
🇺🇸Fargo, North Dakota, United States
University Hospitals of Cleveland Division of Child & Adolescent Psychiatry
🇺🇸Cleveland, Ohio, United States
Vermont Clinical Study Center
🇺🇸Burlington, Vermont, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
Penninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Elite Clinical Trials, Inc.
🇺🇸Wildomar, California, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Amedica Research Institute, Inc.
🇺🇸Hialeah, Florida, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Center for Psychiatry and Behavioral Medicine, Inc.
🇺🇸Las Vegas, Nevada, United States
Bart Sangal
🇺🇸Troy, Michigan, United States
Clinco Inc.
🇺🇸Terre Haute, Indiana, United States
Children's Specialized Hospital
🇺🇸Toms River, New Jersey, United States
CIENTIFICA, Inc. at Prairie View
🇺🇸Newton, Kansas, United States
Bioscience Research, LLC
🇺🇸Mount Kisco, New York, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Valley Clinical Research, Inc.
🇺🇸El Centro, California, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Youth and Family Research Program/WPIC ADHD Research Program
🇺🇸Pittsburgh, Pennsylvania, United States
OCCI, INC (Oregon Center for Clinical Investigations, Inc.)
🇺🇸Salem, Oregon, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Neuroscience, Inc.
🇺🇸Herndon, Virginia, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Future Search Trials
🇺🇸Austin, Texas, United States