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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458445
Recruitment Status : Withdrawn (This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.)
First Posted : April 10, 2007
Last Update Posted : March 5, 2015
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: SPD465 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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)
Study Start Date : April 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458445

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United States, Florida
Meridien Research
Tampa, Florida, United States
Sponsors and Collaborators
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Principal Investigator: Cynthia Huffman, M.D. Meridien Research
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Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical Identifier: NCT00458445    
Other Study ID Numbers: SPD465-311
First Posted: April 10, 2007    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: April 2008
Keywords provided by Shire:
Attention-Deficit Hyperactivity Disorder (ADHD)
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases