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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Massachusetts Institute of Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphetamine ER Tablets, 20 mg | Active Comparator | Double-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline |
|
| Placebo | Placebo Comparator | Matching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphetamine Extended Release (ER) Tablet 20 mg | Drug | A single 20 mg dose of amphetamine ER Tablet, orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Reaction Time Score | Measurement of reaction time across a series of driving simulations | Measured at pre-dose, 45 minutes and 3 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
Current or lifetime history of bipolar disorder or any psychotic disorder.
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.
Known history of chronic medical illnesses including known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, and known family history of sudden death.
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.
Have clinically significant findings in vital signs measurements at Screening including:
Known history or presence of significant renal or hepatic disease.
Use of monoamine oxidase inhibitors (MAOI), e.g. selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue, within 14 days of the Driving Simulator Visit.
Use of ADHD medications including all stimulants (methylphenidate, amphetamine or derivatives of any of these products), within 48 hours of the Driving Simulator Visit.
Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
Known history of allergy/hypersensitivity to amphetamine or any of the components of the test products.
Known history of lack of clinical response to amphetamine based upon Investigator assessment
Any uncontrolled medical condition that, in the opinion of Medical Monitor or Sponsor, would preclude study participation.
History or presence of alcohol dependence or substance abuse disorder or within the last 6 months based upon clinical assessment of the Investigator.
Positive urine pregnancy test at Driving Simulator Visit
Positive breath alcohol test at Driving Simulator Visit.
Patient's inability or unwillingness to follow directions from the study research staff.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Biederman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 11, 2023 | Nov 3, 2023 | 3 | ||
| Feb 12, 2024 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Mar 11, 2024 |
| 4 |