Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01274221 | Withdrawn Phase 3

• 1 other identifier: SPD489-321
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom setting based on the Permanent Product Measure of Performance (PERMP) total score assessed across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover period.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Permanent Product Measure of Performance (PERMP) Total Score

  7 Days

Secondary Outcomes (5)

• Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score

  7 Days

• Conners' Parent Rating Scale - Revised (CPRS-R) Total Score

  7 Days

• Clinical Global Impressions - Global Improvement (CGI-I) Rating Scale Score

  7 Days

• Vital Signs (includes oral or tympanic temperature, sitting blood pressure, pulse and respiratory rate) and Body Height and Weight

  Baseline, Weeks 7, 14, 21, 28, 35 and 42

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, Weeks 7, 14, 21, 28, 35 and 42

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

SPD489

ACTIVE COMPARATOR

Drug: SPD489

Interventions

SPD489 DRUG

1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase

Also known as: Vyvanse, Lisdexamfetamine dimesylate, LDX

SPD489

Placebo OTHER

1 capsule per day for one week of the double-blind crossover phase

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject must be male or female, 13-17 years of age inclusive, at the time of consent.
• The parent/LAR must be available at approximately 7:00 AM (±2 hours) to dispense the dose of investigational product for the study duration.
• Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
• Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
• Subject has an Attention Deficit/Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) total score ≥28.
• Subject is functioning at an age-appropriate level intellectually.
• Subject is able to swallow a capsule.

You may not qualify if:

• Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SPD489 or confound efficacy or safety assessments.
• Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently, demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
• Subject is underweight.
• Subject is significantly overweight.
• 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 conducted in the study or that might increase risk to the subject.
• Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her 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 electrocardiogram (ECG) or clinically significant laboratory abnormality.
• Subject has current abnormal thyroid function. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
• Subject has failed to respond to 1 or more adequate courses (dose and duration) of amphetamine therapy.
• Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
• Subject has a positive urine drug result (with the exception of subject's current stimulant therapy, if any).
• Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening visit.
• Subject has previously been screened for this study or has participated in any other SPD489/NRP104 clinical studies.

Sponsors & Collaborators

• Shire: lead

Study Sites (6)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66211, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

John M. Turnbow, MD, PA

Lubbock, Texas, 79423, United States

Location

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: March 6, 2011
• Primary Completion: May 4, 2011
• Study Completion: May 4, 2011
• Last Updated: June 3, 2021

Record last verified: 2021-05

Locations

US (6)