Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

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)

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).

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Lisdexamfetamine Dimesylate (LDX)

Detailed Description

Not Required

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Study Centers, LLC
  • California
    • El Centro, California, United States, 92243
      • Valley Clinical Research, Inc.
    • Rolling Hills Estates, California, United States, 90274
      • Penninsula Research Associates, Inc.
    • San Diego, California, United States, 92108
      • Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Inc.
  • Florida
    • Bradenton, Florida, United States, 34208
      • Florida Clinical Research Center, LLC
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute, Inc.
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Clinco Inc.
  • Kansas
    • Newton, Kansas, United States, 67114
      • CIENTIFICA, Inc. at Prairie View
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research, Inc.
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research LLC.
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc.
  • Michigan
    • Troy, Michigan, United States, 48085
      • Bart Sangal
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Inc.
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Children's Specialized Hospital
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Triangle Neuropsychiatry, PLLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Innovis Health/Odyssey Research
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland Division of Child & Adolescent Psychiatry
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Eugene, Oregon, United States, 97401
      • OCCI
    • Portland, Oregon, United States, 97210
      • Summit Research Network
    • Salem, Oregon, United States, 97301
      • Occi, Inc (Oregon Center For Clinical Investigations, Inc.)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide
    • Pittsburgh, Pennsylvania, United States, 15213
      • Youth and Family Research Program/WPIC ADHD Research Program
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare
  • Texas
    • Austin, Texas, United States, 78756
      • Future Search Trials
    • Houston, Texas, United States, 77007
      • Bayou City Research, Ltd.
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates P.A.
    • San Antonio, Texas, United States, 78247
      • ADHD Clinic of San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Vermont Clinical Study Center
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc.
    • Midlothian, Virginia, United States, 23112
      • Dominion Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

1. Subject is a male or female aged 13-17 years inclusive at the time of consent of the antecedent study (SPD489-305).
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDX; Lisdexamfetamine Dimesylate (LDX)	Drug: Lisdexamfetamine Dimesylate (LDX); optimal dose of 30, 50 or 70 mg once daily; Other Names: Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and Up to 52 weeks

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2008
• Primary Completion (Actual): April 22, 2010
• Study Completion (Actual): April 22, 2010

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-306