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

Sponsor
Shire (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00458445
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
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)
Actual Study Start Date :
Apr 30, 2007
Actual Primary Completion Date :
Jun 15, 2007
Actual Study Completion Date :
Jun 15, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPD465 then Placebo

Drug: SPD465

Other: Placebo
Placebo is a material that may look similar to SPD465, however, contains no active drug.
Experimental: Placebo then SPD465

Drug: SPD465

Other: Placebo
Placebo is a material that may look similar to SPD465, however, contains no active drug.

Outcome Measures

Primary Outcome Measures

  1. Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit. [Interim visit = Week 3; Final visit = Week 7.]

Secondary Outcome Measures

  1. Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) [Interim visit = Week 3; Final visit = Week 7.]

  2. Interim & final visits: Clinical Global Impressions of Improvement (CGI-I) [Interim visit = Week 3; Final visit = Week 7.]

  3. Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire [Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 25 Years
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.

  1. Subject has used any psychoactive prescription medication or over-the-counter (OTC) medication requiring more than a 28-day washout. Hormonal contraceptives are acceptable.

  2. Subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine.

  3. Subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine).

  4. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.

  5. Female subject is pregnant or lactating.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meridien Research Tampa Florida United States

Sponsors and Collaborators

  • Shire

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00458445
Other Study ID Numbers:
  • SPD465-311
First Posted:
Apr 10, 2007
Last Update Posted:
Jul 6, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Shire
Attention-Deficit Hyperactivity Disorder (ADHD)
Additional relevant MeSH terms:
Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Jul 6, 2021