Clinical trial NCT00500071: Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
Official title: A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 318
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Eligibility criteria: Inclusion Criteria

1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
2. 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.
3. primary diagnosis of ADHD based on a detailed psychiatric evaluation.
4. Subjects must have a baseline ADHD-RS-IV total score ≥28.
5. Subject is functioning at an age-appropriate level intellectually.
6. comply with all the testing and requirements.
7. Subject is able to swallow a capsule.
8. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria

1. 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.
2. Subject has Conduct Disorder.
3. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
6. Subject has a positive urine drug result.
7. Subject weighs less than 50 pounds (22.7kg).
8. Subject is significantly overweight.
9. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
10. Subject has any reported history of abnormal thyroid function.
11. Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
12. 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.
13. The female subject is pregnant or lactating.
14. Subject is well-controlled on their current ADHD medication with acceptable tolerability.

Primary outcomes:
measure: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Weekly Change From Baseline in Total ADHD-RS-IV Score
timeFrame: Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks
measure: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
timeFrame: 7 weeks
measure: Number of Participants With Improvement onParent Global Assessment (PGA)
timeFrame: 7 weeks
measure: Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks
timeFrame: Baseline and 7 weeks
measure: Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: El Centro
country: United States
facility: Valley Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Assoc, Inc
state: California
city: San Francisco
country: United States
facility: UCSF-Langely Porter Psych Institute
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Wildomar
country: United States
facility: Shire Clinical Research Site
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Shire Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: CNS Research Institute, Inc
state: Florida
city: Maitland
country: United States
facility: CORE Research, Inc
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Winter Park
country: United States
facility: Children's Development Center
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Terre Haute
country: United States
facility: Shire Clinical Research Site
state: Indiana
city: Newton
country: United States
facility: Shire Clinical Research Site
state: Kansas
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Lexington
country: United States
facility: Shire Clinical Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Troy
country: United States
facility: Shire Clinical Research Site
state: Michigan
city: Rochester
country: United States
facility: University of Rochester, School of Medicine and Dentistry
state: New York
city: Charlotte
country: United States
facility: Piedmont Neuropsychiatry
state: North Carolina
city: Durham
country: United States
facility: University Commons Office Park
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Moore
country: United States
facility: BHI, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Shire Clinical Research Site
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations, Inc.
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Pittsburgh
country: United States
facility: ADHD Program, Western Psychiatric Institute and Clinic
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic Inc.
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates P.A.
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: ADHD Clinic of San Antonio
state: Texas
city: Herndon
country: United States
facility: NeuroScience, Inc
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Richmond
country: United States
facility: International Clinical Research Associates, LLC
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.