A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators

This study has been withdrawn prior to enrollment.
(This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.)
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00458445
First received: April 2, 2007
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: SPD465
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.

Secondary Outcome Measures:
  • Simulated DS scores & individual components, averaged over the testing times. Interim & final visits: ADHD-RS-IV, CGI-I and Self-Rating of DS Performance Questionnaire. TEAEs, vital signs, lab parameters, physical exams & ECG measurements.

Estimated Enrollment: 46
Study Start Date: April 2007
  Eligibility

Ages Eligible for Study:   19 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must have a valid driver's license with a minimum of 3 years of driving experience.
  2. Subject reports daily driving activity.
  3. Subject is fluent in English.
  4. Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
  5. Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
  6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria

Exclusion criteria:

  1. Subject is significantly underweight or morbidly obese.
  2. Subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining Physician, will contraindicate SPD465 treatment or confound efficacy or safety assessments.
  3. Subject with a lifetime history of psychosis or bipolar disorder.
  4. Subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated.
  5. Subject with a history of mental retardation or a severe learning disability.
  6. Subject is naïve to ADHD treatment with methylphenidate or amphetamine.
  7. Subject has a history of glaucoma or narrow angle glaucoma.
  8. Subject has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
  9. Subject has known cardiac structural abnormalities as well as any other condition that may affect cardiac performance.
  10. Subject has clinically significant ECG or laboratory abnormalities at Screening or Baseline.
  11. Subject has a history of hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg10.
  12. Subject has used any psychoactive prescription medication or over-the-counter (OTC) medication requiring more than a 28-day washout. Hormonal contraceptives are acceptable.
  13. Subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine.
  14. Subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine).
  15. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
  16. Female subject is pregnant or lactating.
  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: NCT00458445

Locations
United States, Florida
Meridien Research
Tampa, Florida, United States
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Cynthia Huffman, M.D. Meridien Research
  More Information

No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00458445     History of Changes
Other Study ID Numbers: SPD465-311
Study First Received: April 2, 2007
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Attention-Deficit Hyperactivity Disorder (ADHD)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014