- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458445
A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators
July 1, 2021 updated by: Shire
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)
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States
- Meridien Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 25 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must have a valid driver's license with a minimum of 3 years of driving experience.
- Subject reports daily driving activity.
- Subject is fluent in English.
- Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
- 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:
- Subject is significantly underweight or morbidly obese.
- 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.
- Subject with a lifetime history of psychosis or bipolar disorder.
- Subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated.
- Subject with a history of mental retardation or a severe learning disability.
- Subject is naïve to ADHD treatment with methylphenidate or amphetamine.
- Subject has a history of glaucoma or narrow angle glaucoma.
- 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.
- Subject has known cardiac structural abnormalities as well as any other condition that may affect cardiac performance.
- Subject has clinically significant ECG or laboratory abnormalities at Screening or Baseline.
- Subject has a history of hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg10.
- Subject has used any psychoactive prescription medication or over-the-counter (OTC) medication requiring more than a 28-day washout. Hormonal contraceptives are acceptable.
- Subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine.
- Subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine).
- Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
- Female subject is pregnant or lactating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPD465 then Placebo
|
Placebo is a material that may look similar to SPD465, however, contains no active drug.
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Experimental: Placebo then SPD465
|
Placebo is a material that may look similar to SPD465, however, contains no active drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Time Frame: Interim visit = Week 3; Final visit = Week 7.
|
Interim visit = Week 3; Final visit = Week 7.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV)
Time Frame: Interim visit = Week 3; Final visit = Week 7.
|
Interim visit = Week 3; Final visit = Week 7.
|
Interim & final visits: Clinical Global Impressions of Improvement (CGI-I)
Time Frame: Interim visit = Week 3; Final visit = Week 7.
|
Interim visit = Week 3; Final visit = Week 7.
|
Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire
Time Frame: Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.
|
Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2007
Primary Completion (Actual)
June 15, 2007
Study Completion (Actual)
June 15, 2007
Study Registration Dates
First Submitted
April 2, 2007
First Submitted That Met QC Criteria
April 9, 2007
First Posted (Estimate)
April 10, 2007
Study Record Updates
Last Update Posted (Actual)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPD465-311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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