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Status:

COMPLETED

Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD

Lead Sponsor:

Tris Pharma, Inc.

Collaborating Sponsors:

Premier Research

Conditions:

ADHD

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

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 year...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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:
  • 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.
  • Exclusion Criteria:
  • 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
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    February 6 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 19 2019

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT03834766

    Start Date

    February 6 2019

    End Date

    October 19 2019

    Last Update

    November 2 2023

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Meridien Research

    Bradenton, Florida, United States, 344201

    2

    Meridien Research, Inc.

    Maitland, Florida, United States, 32751

    3

    Center for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada, United States, 89128