Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)

NCT04027361 | Completed Phase 2 FDA Drug

• 1 other identifier: TRI108-ADD-600
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Amphetamine ER Tablets, 20 mg

ACTIVE COMPARATOR

Double-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline

Drug: Amphetamine Extended Release (ER) Tablet 20 mg

Placebo

PLACEBO COMPARATOR

Matching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline

Drug: Amphetamine Extended Release (ER) Tablet 20 mg

Interventions

Amphetamine Extended Release (ER) Tablet 20 mg DRUG

A single 20 mg dose of amphetamine ER Tablet, orally administered

Also known as: Amphetamine extended-release oral tablet 20 mg

Amphetamine ER Tablets, 20 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead
• Massachusetts General Hospital: collaborator
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Tablets

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 22, 2019
• Study Start: October 1, 2019
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: February 18, 2022

Record last verified: 2021-03

Locations

US (1)