Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: Lisdexamfetamine Dimesylate (LDX)

• 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

Study Timeline

• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-02
• Study Start: 2008-11-13
• Primary Completion: 2010-04-22
• Study Completion: 2010-04-22
• Results First Submitted: 2011-01-31
• Results First Submitted QC: 2011-03-01
• Results First Posted: 2011-03-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (44)

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.; 🇺🇸 Orlando, Florida, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

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