ADHDPhase 2NCT04027361
Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing Amphetamine Extended Release (ER) Tablet 20 mg in people with ADHD, run by Tris Pharma, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- ADHD
- What is being tested?
- Amphetamine Extended Release (ER) Tablet 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 15 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Driving Performance in Patients Aged 18 to 25 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) After a Single-Dose of Amphetamine Extended-Release Tablets: A Pilot, Double-Blind, Placebo-Controlled Study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Amphetamine Extended Release (ER) Tablet 20 mg
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphetamine Extended Release (ER) Tablet 20 mgDrug
Also called Amphetamine extended-release oral tablet 20 mg
A single 20 mg dose of amphetamine ER Tablet, orally administered
| Study group | Role | What they receive |
|---|---|---|
| Amphetamine ER Tablets, 20 mg | Active comparator | Double-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline Receives: Drug: Amphetamine Extended Release (ER) Tablet 20 mg |
| Placebo | Placebo comparator | Matching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline Receives: Drug: Amphetamine Extended Release (ER) Tablet 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Reaction Time Score
Measurement of reaction time across a series of driving simulations
Measured: Measured at pre-dose, 45 minutes and 3 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Oct 2019
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027361
- Sponsor's protocol ID
- TRI108-ADD-600
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Performance in Patients Aged 18 to 25 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) After a Single-Dose of Amphetamine Extended-Release Tablets: A Pilot, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04027361
- Acronym / sponsor ID
- TRI108-ADD-600
- Conditions
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Massachusetts Institute of Technology
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphetamine ER Tablets, 20 mg | Active comparator | Drug: Amphetamine Extended Release (ER) Tablet 20 mgDouble-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline |
| Placebo | Placebo comparator | Drug: Amphetamine Extended Release (ER) Tablet 20 mgMatching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphetamine Extended Release (ER) Tablet 20 mgAlso: Amphetamine extended-release oral tablet 20 mgA single 20 mg dose of amphetamine ER Tablet, orally administered | Drug | Amphetamine ER Tablets, 20 mg, Placebo |
Primary outcome
Change in Composite Reaction Time Score
Time frame: Measured at pre-dose, 45 minutes and 3 hours post-dose
Measurement of reaction time across a series of driving simulations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amphetamine Extended Release (ER) Tablet 20 mg in people with ADHD, run by Tris Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Reaction Time Score (time frame: Measured at pre-dose, 45 minutes and 3 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.