ADHDPhase 3NCT03834766
Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
A Phase 3 study testing AMPH ER Tab 5, 10, 15 and 20 mg in people with ADHD, run by Tris Pharma, Inc. at 3 sites in United States.
Trial summary
To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- AMPH ER Tab 5, 10, 15 and 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Feb 2019to 19 Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 60 years, inclusive at the time of Screening.
- Diagnosed with ADHD using the DSM-5 criteria based on the Adults ADHD Clinical Diagnostic Scale (ACDS).
- IQ within normal range based upon clinical opinion of the Investigator.
- Baseline AISRS total score greater than or equal to 26.
- Baseline score of 4 or higher in CGI-S.
- Females who participate in this study will be of childbearing or non-childbearing potential:
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- Childbearing potential: Physically capable of becoming pregnant
- Non-childbearing potential:
- Permanently sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation for at least 6 weeks or documented successful hysteroscopic sterilization); and/or
- Post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
- Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at Screening.
- Willing to use acceptable, effective methods of contraception.
- Be able to attend the clinic regularly and reliably.
- 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 as established by Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2.
- Current history of major depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder as established by the M.I.N.I. 7.0.2.
- Known history of chronic medical illnesses including untreated thyroid disease, peripheral vasculopathy, 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. Subjects 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
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- Heart rate >100 bpm
- Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment:
- Liver function test results ≥2 times the upper normal limit
- Abnormal blood urea nitrogen, or creatinine levels
- Clinically significant abnormal electrocardiogram or cardiac findings on physical examination (including the presence of a pathologic murmur).
- Use of the following medications within 14 days of Baseline Visit:
- Atomoxetine
- Monoamine oxidase inhibitors (e.g., selegiline, isocarboxazid, phenelzine, tranylcypromine)
- Tricyclic antidepressants (e.g., desipramine, protriptyline).
- Use of the following medications within 3 days of Baseline Visit:
- Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid hydrochloride [HCl], ascorbic acid)
- Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).
- Use of fluoxetine within 30 days of Baseline Visit.
- Use of stimulant medications within 1 week of Baseline Visit.
- Planned use of prohibited drugs or agents from the Screening visit through the end of the study.
- Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
- Abnormal clinically significant laboratory test values at Screening that, in the opinion of the Medical Monitor or Sponsor, would preclude study participation.
- Known history of allergy/hypersensitivity to amphetamine or any of the components of AMPH ER TAB.
- Known history of lack of clinical response to amphetamine based upon Investigator judgment.
- Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- 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 according to DSM-5 or within the last 12 months.
- Subject's inability or unwillingness to follow directions from the study research staff.
- Answer of "yes" to questions 4 or 5 of the C-SSRS within the last 2 years.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Meridien Research
Bradenton, Florida, 344201
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Meridien Research, Inc.
Maitland, Florida, 32751
About this study
To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years.
Read the detailed description
This is a randomized, double-blind (DB), placebo-controlled, parallel, study to assess the efficacy and safety of AMPH ER TAB compared to placebo for the treatment of ADHD in adults aged 18 to 60 years.
After Screening and Baseline evaluations are complete, eligible subjects will be randomized in the study to take DB AMPH ER TAB or matching placebo orally once daily in the morning beginning the day after the Baseline visit for 5 weeks. Dose will be titrated on a weekly basis to reach 20 mg per day. Subjects who cannot tolerate the study drug will be discontinued from the study.
A Math Test placement test will be done at Screening or at Baseline. At Visit 5, efficacy assessments will include the administration of serial Math Tests at pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose (Primary Endpoint) Adult Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression Scale Severity (CGI-S) will be conducted at Baseline and Visits 1 to 5. Digit Symbol Substitution Test (DSST) will be administered at Baseline and Visit 5 (Secondary Endpoints).
Safety assessments will include treatment-emergent adverse events, physical examination, vital signs, body weight, Columbia Suicide Severity Rating Scale (C-SSRS), and direct questioning to assess for sleep, appetite, mood and psychotic events.
- Conditions
- ADHD
- Being tested
- AMPH ER Tab 5, 10, 15 and 20 mg, AMPH ER Tab Matching Placebo 5, 10, 15 and 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.
AMPH ER Tab 5, 10, 15 and 20 mgDrug
Also called Amphetamine Extended Release Tablets
Amphetamine
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mgDrug
Also called Amphetamine Extended Release Tablets Matching Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AMPH ER Tab | Active comparator | Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg Receives: Drug: AMPH ER Tab 5, 10, 15 and 20 mg |
| Matching Placebo | Placebo comparator | Matching Placebo Tablets 5, 10, 15 and 20 mg Receives: Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean Squares Mean (± Standard Error) of Math Test Score Over All Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5)
The Total Math Score is the sum of the number of math problems attempted plus the number of math problems answered correctly and it provides an objective measure of performance that is time-sensitive, ADHD medication-sensitive, and well documented as a measure to evaluate ADHD medication effectiveness throughout the day. The Total Math Score ranges from 0-800 with higher scores indicating better performance.
Measured: Pre-dose to 14 hour post-dose
Secondary outcomes (4)
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
AISRS scale was developed to better capture symptoms of ADHD in adult patients. The scale has 18 items scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points.
Measured: Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)
Change From Baseline to Visit 5 on DSST
The Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. The DSST is a 90 second test requiring participants to match symbols with numbers according to a code. Potential scores range from 0 to 100, and lower scores indicate worse performance.
Measured: From baseline to week 5
Change From Baseline on Total Math Test Score Over Each Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5)
The Total Math Score is the sum of the number of math problems attempted plus the number of math problems answered correctly and it provides an objective measure of performance that is time-sensitive, ADHD medication-sensitive, and well documented as a measure to evaluate ADHD medication effectiveness throughout the day. The Total Math Score ranges from 0-800 with higher scores indicating better performance.
Measured: Visit 5 (week 5)
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Measured: Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start6 Feb 2019
- Primary completion19 Oct 2019
- Study completion19 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind (DB), placebo-controlled, parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Andrew J. Cutler, MD, Principal investigator, Meridien Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834766
- Sponsor's protocol ID
- TRI108-ADD-400
- Status last verified
- Dec 2019
- First submitted
- 4 Feb 2019
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutler AJ, Childress AC, Pardo A, Duhoux S, Gomeni R, Rafla E, King TR, Kando JC. Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2022 Jul 20;83(5):22m14438. doi: 10.4088/JCP.22m14438.
PubMed 35857716
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
- ClinicalTrials.gov ID
- NCT03834766
- Acronym / sponsor ID
- TRI108-ADD-400
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 19 Oct 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years.
Detailed description
This is a randomized, double-blind (DB), placebo-controlled, parallel, study to assess the efficacy and safety of AMPH ER TAB compared to placebo for the treatment of ADHD in adults aged 18 to 60 years.
After Screening and Baseline evaluations are complete, eligible subjects will be randomized in the study to take DB AMPH ER TAB or matching placebo orally once daily in the morning beginning the day after the Baseline visit for 5 weeks. Dose will be titrated on a weekly basis to reach 20 mg per day. Subjects who cannot tolerate the study drug will be discontinued from the study.
A Math Test placement test will be done at Screening or at Baseline. At Visit 5, efficacy assessments will include the administration of serial Math Tests at pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose (Primary Endpoint) Adult Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression Scale Severity (CGI-S) will be conducted at Baseline and Visits 1 to 5. Digit Symbol Substitution Test (DSST) will be administered at Baseline and Visit 5 (Secondary Endpoints).
Safety assessments will include treatment-emergent adverse events, physical examination, vital signs, body weight, Columbia Suicide Severity Rating Scale (C-SSRS), and direct questioning to assess for sleep, appetite, mood and psychotic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind (DB), placebo-controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| AMPH ER Tab | Active comparator | Drug: AMPH ER Tab 5, 10, 15 and 20 mgAmphetamine Extended Release Tablets 5, 10, 15 and 20 mg |
| Matching Placebo | Placebo comparator | Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mgMatching Placebo Tablets 5, 10, 15 and 20 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female aged 18 to 60 years, inclusive at the time of Screening.
- Diagnosed with ADHD using the DSM-5 criteria based on the Adults ADHD Clinical Diagnostic Scale (ACDS).
- IQ within normal range based upon clinical opinion of the Investigator.
- Baseline AISRS total score greater than or equal to 26.
- Baseline score of 4 or higher in CGI-S.
Key exclusion criteria (30 listed)
- Current or lifetime history of bipolar disorder or any psychotic disorder as established by Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2.
- Current history of major depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder as established by the M.I.N.I. 7.0.2.
- Known history of chronic medical illnesses including untreated thyroid disease, peripheral vasculopathy, 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. Subjects 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 |
|---|---|---|
| AMPH ER Tab 5, 10, 15 and 20 mgAlso: Amphetamine Extended Release TabletsAmphetamine | Drug | AMPH ER Tab |
| AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mgAlso: Amphetamine Extended Release Tablets Matching PlaceboPlacebo | Drug | Matching Placebo |
Primary outcome
Lean Squares Mean (± Standard Error) of Math Test Score Over All Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5)
Time frame: Pre-dose to 14 hour post-dose
The Total Math Score is the sum of the number of math problems attempted plus the number of math problems answered correctly and it provides an objective measure of performance that is time-sensitive, ADHD medication-sensitive, and well documented as a measure to evaluate ADHD medication effectiveness throughout the day. The Total Math Score ranges from 0-800 with higher scores indicating better performance.
4 secondary outcomes
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Time frame: Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)
Change From Baseline to Visit 5 on DSST
Time frame: From baseline to week 5
Change From Baseline on Total Math Test Score Over Each Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5)
Time frame: Visit 5 (week 5)
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Time frame: Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35857716Cutler AJ, Childress AC, Pardo A, Duhoux S, Gomeni R, Rafla E, King TR, Kando JC. Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2022 Jul 20;83(5):22m14438. doi: 10.4088/JCP.22m14438.
- Individual participant dataSharing planned: No
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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.
Andrew J. Cutler, MD principal investigator
Meridien Research Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMPH ER Tab 5, 10, 15 and 20 mg in people with ADHD, run by Tris Pharma, Inc. at 3 sites 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 15 inclusion and 30 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lean Squares Mean (± Standard Error) of Math Test Score Over All Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5) (time frame: Pre-dose to 14 hour post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834766, which also lists 1 linked publication.
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 2 Nov 2023.