Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effect on driving performance of a single dose of amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and 10 hours post-dose in young adults with ADHD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
At a single US-based study site, a driving simulation will be used to assess the effect on driving performance for the co-primary endpoints, study subjects' driving performance at 45 minutes and 10 hours post-dose, compared with placebo. Eligible subjects will be prescreened for ADHD but otherwise healthy, aged 18-25 years.
Driving simulations that simulate common driving events to which the study subject must react. The reactions to each event will be assessed. Using a parallel-group design, subjects will be assessed while on study drug, and while on placebo.
Safety assessments will include spontaneously reported treatment-emergent adverse events and vital signs at 4 hours post-dose.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Amphetamine ER Tablets, 20 mg Double-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline |
Drug: Amphetamine Extended Release (ER) Tablet 20 mg
A single 20 mg dose of amphetamine ER Tablet, orally administered
Other Names:
|
| Placebo Comparator: Placebo Matching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline |
Drug: Amphetamine Extended Release (ER) Tablet 20 mg
A single 20 mg dose of amphetamine ER Tablet, orally administered
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Composite Reaction Time Score [Measured at pre-dose, 45 minutes and 3 hours post-dose]
Measurement of reaction time across a series of driving simulations
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females aged 18 to 25 years, inclusive, at the time of screening who have a valid driver's license.
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Normal visual acuity (either uncorrected or corrected with glasses, contact lenses or surgery) at Screening based upon clinical assessment of the Investigator
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Diagnosed with ADHD using the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) criteria based on ADHD module from the Mini-International Neuropsychiatric Interview (M.I.N.I) version 7.0.2.
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IQ within normal range based upon clinical assessment of the Investigator.
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For female participants, presently using an acceptable method of contraception based upon clinical assessment of the Investigator.
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Willing to abstain from using any forms of cannabinoids (THC, CBD, hemp oil, etc.) for 2 weeks prior to the Driving Simulation Visit (if applicable).
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Be able to understand, read, write, and speak English fluently to complete the study related materials.
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Be informed of the nature of the study and give written consent prior to any study procedure.
Exclusion Criteria:
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Current or lifetime history of bipolar disorder or any psychotic disorder.
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Current active symptoms of major depression generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder based upon clinical assessment of the Investigator.
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Known history of chronic medical illnesses including known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, and known family history of sudden death.
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History of uncontrolled hypertension or a resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg. Patients with well-controlled hypertension on a stable dose for at least 3 months of anti-hypertensives will be allowed to participate.
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Have clinically significant findings in vital signs measurements at Screening including:
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Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg (average of triplicate measurements)
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Heart rate >100 bpm (average of triplicate measurements)
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Known history or presence of significant renal or hepatic disease.
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Use of monoamine oxidase inhibitors (MAOI), e.g. selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue, within 14 days of the Driving Simulator Visit.
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Use of ADHD medications including all stimulants (methylphenidate, amphetamine or derivatives of any of these products), within 48 hours of the Driving Simulator Visit.
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Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
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Known history of allergy/hypersensitivity to amphetamine or any of the components of the test products.
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Known history of lack of clinical response to amphetamine based upon Investigator assessment
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Any uncontrolled medical condition that, in the opinion of Medical Monitor or Sponsor, would preclude study participation.
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History or presence of alcohol dependence or substance abuse disorder or within the last 6 months based upon clinical assessment of the Investigator.
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Positive urine pregnancy test at Driving Simulator Visit
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Positive breath alcohol test at Driving Simulator Visit.
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Patient's inability or unwillingness to follow directions from the study research staff.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Tris Pharma, Inc.
- Massachusetts General Hospital
- Massachusetts Institute of Technology
Investigators
- Principal Investigator: Joseph Biederman, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRI108-ADD-600