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Trial record 1 of 1 for:    NCT03834766
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Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834766
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Tris Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
ADHD Drug: AMPH ER Tab 5, 10, 15 and 20 mg Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg Phase 3

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.

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Primary Purpose: Treatment
Official Title: Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : October 19, 2019
Actual Study Completion Date : October 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AMPH ER Tab
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
Drug: AMPH ER Tab 5, 10, 15 and 20 mg
Amphetamine
Other Name: Amphetamine Extended Release Tablets

Placebo Comparator: Matching Placebo
Matching Placebo Tablets 5, 10, 15 and 20 mg
Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg
Placebo
Other Name: Amphetamine Extended Release Tablets Matching Placebo




Primary Outcome Measures :
  1. Math Test score over all post-dose time points assessed during the administration of serial Math Tests at Visit 5 [ Time Frame: 6 monts ]
    The primary efficacy endpoint will be assessed using a linear Mixed Model Repeated Measures (MMRM) analysis using SAS® PROC MIXED. The model will include treatment, time and treatment by time as fixed effects and subject as a random effect. Pre-dose Math Test score will be included as a covariate. The difference between AMPH ER TAB and placebo will be assessed at the alpha = 0.05 level of significance.


Secondary Outcome Measures :
  1. Onset of clinical effect [ Time Frame: 6 months ]
    Defined as the first time point post-dose when treatment effect of AMPH ER TAB versus placebo, evaluated using Math Test scores (attempted + correct) is significant.

  2. Duration of clinical effect [ Time Frame: 6 months ]
    Defined as the time between last time point to the first time point post-dose with significant treatment effect of AMPH ER TAB versus placebo evaluated using Math Test scores (attempted + correct).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834766


Locations
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United States, Florida
Meridien Research
Bradenton, Florida, United States, 344201
Meridien Research, Inc.
Maitland, Florida, United States, 32751
United States, Nevada
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
Tris Pharma, Inc.
Premier Research Group plc
Investigators
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Principal Investigator: Andrew J. Cutler, MD Meridien Research Inc.
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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03834766    
Other Study ID Numbers: TRI108-ADD-400
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors