Status:
COMPLETED
Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Tris Pharma, Inc.
Collaborating Sponsors:
Massachusetts General Hospital
Massachusetts Institute of Technology
Conditions:
ADHD
Eligibility:
All Genders
18-25 years
Phase:
PHASE2
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-d...
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 ho...
Eligibility Criteria
Inclusion
- Males or females aged 18 to 25 years, inclusive, at the time of screening who have a valid driver's license.
- Normal visual acuity (either uncorrected or corrected with glasses, contact lenses or surgery) at Screening based upon clinical assessment of the Investigator
- 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.
- IQ within normal range based upon clinical assessment of the Investigator.
- For female participants, presently using an acceptable method of contraception based upon clinical assessment of the Investigator.
- 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).
- Be able to understand, read, write, and speak English fluently to complete the study related materials.
- Be informed of the nature of the study and give written consent prior to any study procedure.
Exclusion
- 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:
- Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg (average of triplicate measurements)
- Heart rate \>100 bpm (average of triplicate measurements)
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04027361
Start Date
October 1 2019
End Date
October 15 2021
Last Update
February 18 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114