Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

NCT00764868 | Completed Phase 3 Results

• 1 other identifier: SPD489-306
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 45

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)

  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

  Baseline and Up to 52 weeks

Study Arms (1)

LDX

EXPERIMENTAL

Lisdexamfetamine Dimesylate (LDX)

Drug: Lisdexamfetamine Dimesylate (LDX)

Interventions

Lisdexamfetamine Dimesylate (LDX) DRUG

optimal dose of 30, 50 or 70 mg once daily

Also known as: Vyvanse

LDX

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject has any clinically significant ECG, based on the Principal Investigator's judgment, at Visit 4/ET of the antecedent study (SPD489-305).
• Subject is taking any medication that is excluded.
• Subject has a documented allergy, hypersensitivity or intolerance to amphetamine.
• 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.
• Subject has glaucoma.
• Subject is female and is pregnant or lactating.

Sponsors & Collaborators

• Shire: lead

Study Sites (45)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

Valley Clinical Research, Inc.

El Centro, California, 92243, United States

Location

Penninsula Research Associates, Inc.

Rolling Hills Estates, California, 90274, United States

Location

Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)

San Diego, California, 92108, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Amedica Research Institute, Inc.

Hialeah, Florida, 33013, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Clinco Inc.

Terre Haute, Indiana, 47802, United States

Location

CIENTIFICA, Inc. at Prairie View

Newton, Kansas, 67114, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

Pedia Research LLC.

Owensboro, Kentucky, 42301, United States

Location

Four Rivers Clinical Research, Inc.

Paducah, Kentucky, 42003, United States

Location

Louisiana Research Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Bart Sangal

Troy, Michigan, 48085, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Children's Specialized Hospital

Toms River, New Jersey, 08755, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Triangle Neuropsychiatry, PLLC

Durham, North Carolina, 27707, United States

Location

Innovis Health/Odyssey Research

Fargo, North Dakota, 58104, United States

Location

University Hospitals of Cleveland Division of Child & Adolescent Psychiatry

Cleveland, Ohio, 44106, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

OCCI

Eugene, Oregon, 97401, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

OCCI, INC (Oregon Center for Clinical Investigations, Inc.)

Salem, Oregon, 97301, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

Youth and Family Research Program/WPIC ADHD Research Program

Pittsburgh, Pennsylvania, 15213, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Future Search Trials

Austin, Texas, 78756, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

Red Oak Psychiatry Associates P.A.

Houston, Texas, 77090, United States

Location

ADHD Clinic of San Antonio

San Antonio, Texas, 78247, United States

Location

Vermont Clinical Study Center

Burlington, Vermont, 05401, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

Neuroscience, Inc.

Herndon, Virginia, 20170, United States

Location

Dominion Clinical Research

Midlothian, Virginia, 23112, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• 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.

  PMID: 23410138 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: October 2, 2008
• Study Start: November 13, 2008
• Primary Completion: April 22, 2010
• Study Completion: April 22, 2010
• Last Updated: June 14, 2021
• Results First Posted: March 28, 2011

Record last verified: 2021-06

Locations

US (45)