Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
Condition: ADHD
Intervention: AMPH ER Tab 5, 10, 15 and 20 mg; AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg
Intervention description: Amphetamine; Placebo
Intervention MeSH terms: Amphetamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind (DB), placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: AMPH ER Tab 5, 10, 15 & 20 mg Vs. Matching Placebo
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged
      18 to 60 years.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female aged 18 to 60 years, inclusive at the time of Screening.

          2. Diagnosed with ADHD using the DSM-5 criteria based on the Adults ADHD Clinical
             Diagnostic Scale (ACDS).

          3. IQ within normal range based upon clinical opinion of the Investigator.

          4. Baseline AISRS total score greater than or equal to 26.

          5. Baseline score of 4 or higher in CGI-S.

          6. Females who participate in this study will be of childbearing or non-childbearing
             potential:

               -  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).

          7. Females of childbearing potential must be non-lactating and must have a negative serum
             pregnancy test at Screening.

          8. Willing to use acceptable, effective methods of contraception.

          9. Be able to attend the clinic regularly and reliably.

         10. Be able to understand, read, write, and speak English fluently to complete the study
             related materials.

         11. Be informed of the nature of the study and give written consent prior to any study
             procedure.

        Exclusion Criteria:

          1. 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.

          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.

          3. 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.

          4. 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.

          5. Have clinically significant findings in vital signs measurements at Screening
             including:

               -  Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg

               -  Heart rate >100 bpm

          6. 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

          7. Clinically significant abnormal electrocardiogram or cardiac findings on physical
             examination (including the presence of a pathologic murmur).

          8. 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).

          9. 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).

         10. Use of fluoxetine within 30 days of Baseline Visit.

         11. Use of stimulant medications within 1 week of Baseline Visit.

         12. Planned use of prohibited drugs or agents from the Screening visit through the end of
             the study.

         13. Participation in a clinical study in which an investigational drug was administered
             within 30 days prior to Screening.

         14. Abnormal clinically significant laboratory test values at Screening that, in the
             opinion of the Medical Monitor or Sponsor, would preclude study participation.

         15. Known history of allergy/hypersensitivity to amphetamine or any of the components of
             AMPH ER TAB.

         16. Known history of lack of clinical response to amphetamine based upon Investigator
             judgment.

         17. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

         18. Any uncontrolled medical condition that, in the opinion of Medical Monitor or Sponsor,
             would preclude study participation.

         19. History or presence of alcohol dependence or substance abuse disorder according to
             DSM-5 or within the last 12 months.

         20. Subject's inability or unwillingness to follow directions from the study research
             staff.

         21. Answer of "yes" to questions 4 or 5 of the C-SSRS within the last 2 years.