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

NCT03834766 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TRI108-ADD-400
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-dose to 14 hour post-dose

Secondary Outcomes (4)

• Change From Baseline in AISRS Total Score at Each Post-baseline Visit

  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

  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)

  Visit 5 (week 5)

• Change From Baseline in CGI-S Total Score at Each Post-baseline Visit

  Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)

Study Arms (2)

AMPH ER Tab

ACTIVE COMPARATOR

Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg

Drug: AMPH ER Tab 5, 10, 15 and 20 mg

Matching Placebo

PLACEBO COMPARATOR

Matching Placebo Tablets 5, 10, 15 and 20 mg

Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg

Interventions

AMPH ER Tab 5, 10, 15 and 20 mg DRUG

Amphetamine

Also known as: Amphetamine Extended Release Tablets

AMPH ER Tab

AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg DRUG

Placebo

Also known as: Amphetamine Extended Release Tablets Matching Placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tris Pharma, Inc.: lead
• Premier Research: collaborator

Study Sites (3)

Meridien Research

Bradenton, Florida, 344201, United States

Location

Meridien Research, Inc.

Maitland, Florida, 32751, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Related Publications (1)

• 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.

  PMID: 35857716 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Antonio Pardo
• Organization: Tris Pharma, Inc.

apardo@trispharma.com

19175149058

Study Officials

• Andrew J. Cutler, MD

  Meridien Research Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: AMPH ER Tab 5, 10, 15 \& 20 mg Vs. Matching Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind (DB), placebo-controlled, parallel study

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: February 6, 2019
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)