Trial · NCT03834766

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

NCT03834766, Phase 3, Completed, Tris Pharma, Inc.; results first posted 2023-11-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD. Trials, record NCT03834766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03834766

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
NCT number: NCT03834766
Status: Completed
Phases: Phase 3
Enrollment: 130 participants, actual
Lead sponsor: Tris Pharma, Inc.
Conditions: ADHD
Interventions: AMPH ER Tab 5, 10, 15 and 20 mg, AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg
First posted: 2019-02-08
Last updated: 2023-11-02
Results first posted: 2023-11-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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)	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.
Secondary	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)	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.
Secondary	Change From Baseline to Visit 5 on DSST	From baseline to week 5	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.
Secondary	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)	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.
Secondary	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)	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	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)	Pre-dose to 14 hour post-dose	Score on a scale	MEAN
SECONDARY	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)	Score on a scale	MEAN
SECONDARY	Change From Baseline to Visit 5 on DSST	From baseline to week 5	Score on a scale	MEAN
SECONDARY	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)	Score on a scale	MEAN
SECONDARY	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)	Score on a scale	MEAN

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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)	AMPH ER Tab		259.5	Standard Deviation 69.40	Score on a scale
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)	Matching Placebo		260.6	Standard Deviation 77.75	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	AMPH ER Tab	Visit 1	-7.2	Standard Deviation 7.94	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	Matching Placebo	Visit 1	-5.3	Standard Deviation 5.95	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	AMPH ER Tab	Visit 2	-11.2	Standard Deviation 9.45	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	Matching Placebo	Visit 2	-8.1	Standard Deviation 7.22	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	AMPH ER Tab	Visit 3	-15	Standard Deviation 9.08	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	Matching Placebo	Visit 3	-8.8	Standard Deviation 8.38	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	AMPH ER Tab	Visit 4	-15.4	Standard Deviation 10.36	Score on a scale
Change From Baseline in AISRS Total Score at Each Post-baseline Visit	Matching Placebo	Visit 4	-9.3	Standard Deviation 9.47	Score on a scale

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AMPH ER Tab	62
Overall Study	STARTED	Matching Placebo	65
Overall Study	COMPLETED	AMPH ER Tab	45
Overall Study	COMPLETED	Matching Placebo	46
Overall Study	NOT COMPLETED	AMPH ER Tab	17
Overall Study	NOT COMPLETED	Matching Placebo	19

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Insomnia	Psychiatric disorders	AMPH ER Tab	14	62
other	Insomnia	Psychiatric disorders	Matching Placebo	8	65
other	Irritability	Psychiatric disorders	AMPH ER Tab	11	62
other	Irritability	Psychiatric disorders	Matching Placebo	5	65
other	Initial insomnia	Psychiatric disorders	AMPH ER Tab	5	62
other	Initial insomnia	Psychiatric disorders	Matching Placebo	3	65
other	Anxiety	Psychiatric disorders	AMPH ER Tab	5	62
other	Anxiety	Psychiatric disorders	Matching Placebo	0	65
other	Decreased Appetite	Metabolism and nutrition disorders	AMPH ER Tab	30	62
other	Decreased Appetite	Metabolism and nutrition disorders	Matching Placebo	14	65

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AMPH ER Tab	0	62
Total, all-cause mortality	Matching Placebo	0	65
Total, other adverse events	AMPH ER Tab	54	62
Total, other adverse events	Matching Placebo	35	65
Total, serious adverse events	AMPH ER Tab	0	62
Total, serious adverse events	Matching Placebo	0	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35857716	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AMPH ER Tab vs Matching Placebo: deaths from any cause	Trial comparisons
AMPH ER Tab vs Matching Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Symbol Coding	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03834766

GET https://conductscience.org/api/trials/v1/NCT03834766/results?page=2

API reference For AI assistants