Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00764868
First received: September 29, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
ADHD
Drug: Lisdexamfetamine Dimesylate (LDX)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
    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:
  • Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Up to 52 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 269
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDX
Lisdexamfetamine Dimesylate (LDX)
Drug: Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily
Other Name: Vyvanse

Detailed Description:

Not Required

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764868

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

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00764868     History of Changes
Other Study ID Numbers: SPD489-306
Study First Received: September 29, 2008
Results First Received: January 31, 2011
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014