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

This study has been withdrawn prior to enrollment.
(Cancellation was not safety related but a shift in study priorities for Shire.)
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT01274221
First received: January 7, 2011
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: SPD489
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Double-blind, Multicenter, Placebo Controlled, Dose Optimization, Crossover, Analog Classroom, Safety and Efficacy Study of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD))

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Permanent Product Measure of Performance (PERMP) Total Score [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Conners' Parent Rating Scale - Revised (CPRS-R) Total Score [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Global Improvement (CGI-I) Rating Scale Score [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Vital Signs (includes oral or tympanic temperature, sitting blood pressure, pulse and respiratory rate) and Body Height and Weight [ Time Frame: Baseline, Weeks 7, 14, 21, 28, 35 and 42 ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, Weeks 7, 14, 21, 28, 35 and 42 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
1 capsule per day for one week of the double-blind crossover phase
Active Comparator: SPD489 Drug: SPD489
1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase
Other Name: Vyvanse, Lisdexamfetamine dimesylate, LDX

  Eligibility

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

Inclusion Criteria:

  1. Subject must be male or female, 13-17 years of age inclusive, at the time of consent.
  2. The parent/LAR must be available at approximately 7:00 AM (±2 hours) to dispense the dose of investigational product for the study duration.
  3. 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.
  4. 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.
  5. Subject has an Attention Deficit/Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) total score ≥28.
  6. Subject is functioning at an age-appropriate level intellectually.
  7. Subject is able to swallow a capsule.

Exclusion Criteria:

  1. 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.
  2. Subject has a documented history of aggressive behavior serious enough to preclude participation in regular classroom activities, as determined by the Investigator. Oppositional defiant disorder is not exclusionary.
  3. 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
  4. Subject is underweight.
  5. Subject is significantly overweight.
  6. 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.
  7. Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis, and/or a known family history of Tourette's Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary.
  8. 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.
  9. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  10. Subject has any clinically significant electrocardiogram (ECG) or clinically significant laboratory abnormality.
  11. Subject has current abnormal thyroid function. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  12. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
  13. Subject has failed to respond to 1 or more adequate courses (dose and duration) of amphetamine therapy.
  14. Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
  15. Subject has a positive urine drug result (with the exception of subject's current stimulant therapy, if any).
  16. Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening visit.
  17. Subject has previously been screened for this study or has participated in any other SPD489/NRP104 clinical studies.
  18. Subject has glaucoma.
  19. 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.
  20. Subject is female and is pregnant or lactating.
  21. Subject is well controlled on his/her current ADHD medication with acceptable tolerability.
  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: NCT01274221

Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
United States, Kansas
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66211
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, Texas
Bayou City Research, Ltd.
Houston, Texas, United States, 77007
John M. Turnbow, MD, PA
Lubbock, Texas, United States, 79423
Sponsors and Collaborators
Shire
  More Information

No publications provided

Responsible Party: Timothy Whitaker, MD, Shire Pharmaceutical Development Inc.
ClinicalTrials.gov Identifier: NCT01274221     History of Changes
Other Study ID Numbers: SPD489-321
Study First Received: January 7, 2011
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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