Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

NCT00500071 | Completed Phase 4 Results

• 1 other identifier: SPD489-310
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 46

Brief Summary

Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks

  Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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 7 weeks

Secondary Outcomes (5)

• Weekly Change From Baseline in Total ADHD-RS-IV Score

  Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks

• Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)

  7 weeks

• Number of Participants With Improvement onParent Global Assessment (PGA)

  7 weeks

• Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks

  Baseline and 7 weeks

• Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks

  Baseline and 7 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Vyvanse (lisdexamfetamine dimesylate)

Interventions

Vyvanse (lisdexamfetamine dimesylate) DRUG

Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.

1

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is a male or female aged 6-12 years inclusive at the time of consent.
• Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
• primary diagnosis of ADHD based on a detailed psychiatric evaluation.
• Subjects must have a baseline ADHD-RS-IV total score ≥28.
• Subject is functioning at an age-appropriate level intellectually.
• comply with all the testing and requirements.
• Subject is able to swallow a capsule.
• Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

You may not qualify if:

• Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms 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.
• Subject has Conduct Disorder.
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
• Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
• The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
• Subject has a positive urine drug result.
• Subject weighs less than 50 pounds (22.7kg).
• Subject is significantly overweight.
• Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
• Subject has any reported history of abnormal thyroid function.
• Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments.
• The female subject is pregnant or lactating.
• Subject is well-controlled on their current ADHD medication with acceptable tolerability.

Sponsors & Collaborators

• Shire: lead

Study Sites (46)

Melmed Center

Scottsdale, Arizona, United States

Location

Valley Clinical Research

El Centro, California, United States

Location

Peninsula Research Assoc, Inc

Rolling Hills Estates, California, United States

Location

UCSF-Langely Porter Psych Institute

San Francisco, California, United States

Location

Encompass Clinical Research

Spring Valley, California, United States

Location

Shire Clinical Research Site

Wildomar, California, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, United States

Location

Shire Clinical Research Site

Hialeah, Florida, United States

Location

CNS Research Institute, Inc

Jacksonville, Florida, United States

Location

CORE Research, Inc

Maitland, Florida, United States

Location

Miami Research Associates

Miami, Florida, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Location

Children's Development Center

Winter Park, Florida, United States

Location

Capstone Clinical Research

Libertyville, Illinois, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

Shire Clinical Research Site

Terre Haute, Indiana, United States

Location

Shire Clinical Research Site

Newton, Kansas, United States

Location

Psychiatric Associates

Overland Park, Kansas, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Location

Shire Clinical Research Site

Lexington, Kentucky, United States

Location

Pedia Research

Owensboro, Kentucky, United States

Location

Four Rivers Clinical Research, Inc.

Paducah, Kentucky, United States

Location

Shire Clinical Research Site

Troy, Michigan, United States

Location

University of Rochester, School of Medicine and Dentistry

Rochester, New York, United States

Location

Piedmont Neuropsychiatry

Charlotte, North Carolina, United States

Location

University Commons Office Park

Durham, North Carolina, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, United States

Location

BHI, Inc.

Moore, Oklahoma, United States

Location

Shire Clinical Research Site

Oklahoma City, Oklahoma, United States

Location

Oregon Center for Clinical Investigations, Inc

Eugene, Oregon, United States

Location

Oregon Center For Clinical Investigations, Inc.

Portland, Oregon, United States

Location

Summit Research Network

Portland, Oregon, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, United States

Location

ADHD Program, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Location

The Jackson Clinic

Jackson, Tennessee, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, United States

Location

FutureSearch Trials

Austin, Texas, United States

Location

Claghorn-Lesem Research Clinic Inc.

Bellaire, Texas, United States

Location

Red Oak Psychiatry Associates P.A.

Houston, Texas, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Location

ADHD Clinic of San Antonio

San Antonio, Texas, United States

Location

NeuroScience, Inc

Herndon, Virginia, United States

Location

Dominion Clinical Research

Midlothian, Virginia, United States

Location

International Clinical Research Associates, LLC

Richmond, Virginia, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, United States

Location

Related Publications (3)

• Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):649-62. doi: 10.1089/cap.2008.0165.

  PMID: 20035583 RESULT

• Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Turgay A, Findling RL. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord. 2012 Jul;16(5):384-97. doi: 10.1177/1087054710389990. Epub 2010 Dec 20.

  PMID: 21173426 RESULT

• Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Findling RL. Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):503-11. doi: 10.1089/cap.2009.0110.

  PMID: 21186969 RESULT

Related Links

• FDA recall information

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: June 28, 2007
• Primary Completion: January 2, 2008
• Study Completion: January 2, 2008
• Last Updated: March 10, 2022
• Results First Posted: September 1, 2009

Record last verified: 2022-02

Locations

US (46)