Trial Outcomes & Findings for Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD (NCT NCT03834766)
NCT ID: NCT03834766
Last Updated: 2023-11-02
Results Overview
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.
COMPLETED
PHASE3
130 participants
Pre-dose to 14 hour post-dose
2023-11-02
Participant Flow
A total of 166 subjects was screened; 36 subjects failed screening. A total of 130 subjects were randomized, 65 to each treatment arm. Three subjects randomized to AMPH ER TAB did not receive drug, resulting in 127 subjects who started the study.
Participant milestones
| Measure |
AMPH ER Tab
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
65
|
|
Overall Study
COMPLETED
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
Baseline characteristics by cohort
| Measure |
AMPH ER Tab
n=62 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=65 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
65 participants
n=7 Participants
|
127 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose to 14 hour post-doseThe 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.
Outcome measures
| Measure |
AMPH ER Tab
n=45 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=46 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
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)
|
259.5 Score on a scale
Standard Deviation 69.40
|
260.6 Score on a scale
Standard Deviation 77.75
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AMPH ER Tab
n=62 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=62 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Visit 3
|
-15 Score on a scale
Standard Deviation 9.08
|
-8.8 Score on a scale
Standard Deviation 8.38
|
|
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Visit 1
|
-7.2 Score on a scale
Standard Deviation 7.94
|
-5.3 Score on a scale
Standard Deviation 5.95
|
|
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Visit 2
|
-11.2 Score on a scale
Standard Deviation 9.45
|
-8.1 Score on a scale
Standard Deviation 7.22
|
|
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Visit 4
|
-15.4 Score on a scale
Standard Deviation 10.36
|
-9.3 Score on a scale
Standard Deviation 9.47
|
|
Change From Baseline in AISRS Total Score at Each Post-baseline Visit
Visit 5
|
-15.9 Score on a scale
Standard Deviation 10.98
|
-9.5 Score on a scale
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: From baseline to week 5The 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.
Outcome measures
| Measure |
AMPH ER Tab
n=62 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=62 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
Change From Baseline to Visit 5 on DSST
|
4.8 Score on a scale
Standard Deviation 7.64
|
6.5 Score on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AMPH ER Tab
n=45 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=46 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
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)
0.5 hours
|
64.5 Score on a scale
Standard Deviation 106.21
|
39.7 Score on a scale
Standard Deviation 82.74
|
|
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)
1 hours
|
67.9 Score on a scale
Standard Deviation 107.43
|
27.8 Score on a scale
Standard Deviation 84.10
|
|
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)
2 hours
|
84.4 Score on a scale
Standard Deviation 115.37
|
47.0 Score on a scale
Standard Deviation 84.12
|
|
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)
4 hours
|
81.7 Score on a scale
Standard Deviation 121.72
|
53.0 Score on a scale
Standard Deviation 87.84
|
|
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)
8 hours
|
78.8 Score on a scale
Standard Deviation 121.72
|
48.2 Score on a scale
Standard Deviation 90.28
|
|
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)
10 hours
|
81.2 Score on a scale
Standard Deviation 118.64
|
53.8 Score on a scale
Standard Deviation 85.10
|
|
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)
12 hours
|
85.2 Score on a scale
Standard Deviation 111.18
|
58.3 Score on a scale
Standard Deviation 94.97
|
|
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)
13 hours
|
88.8 Score on a scale
Standard Deviation 120.45
|
47.7 Score on a scale
Standard Deviation 84.07
|
|
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)
14 hours
|
89 Score on a scale
Standard Deviation 122.89
|
62.9 Score on a scale
Standard Deviation 78.34
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AMPH ER Tab
n=62 Participants
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=65 Participants
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Visit 1
|
-0.6 Score on a scale
Standard Deviation 0.89
|
-0.3 Score on a scale
Standard Deviation 0.52
|
|
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Visit 2
|
-1.0 Score on a scale
Standard Deviation 1.02
|
-0.6 Score on a scale
Standard Deviation 0.68
|
|
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Visit 3
|
-1.3 Score on a scale
Standard Deviation 1.20
|
-0.6 Score on a scale
Standard Deviation 0.79
|
|
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Visit 4
|
-1.4 Score on a scale
Standard Deviation 1.17
|
-0.8 Score on a scale
Standard Deviation 1.10
|
|
Change From Baseline in CGI-S Total Score at Each Post-baseline Visit
Visit 5
|
-1.3 Score on a scale
Standard Deviation 1.24
|
-0.7 Score on a scale
Standard Deviation 0.97
|
Adverse Events
AMPH ER Tab
Matching Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AMPH ER Tab
n=62 participants at risk
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
AMPH ER Tab 5, 10, 15 and 20 mg: Amphetamine
|
Matching Placebo
n=65 participants at risk
Matching Placebo Tablets 5, 10, 15 and 20 mg
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg: Placebo
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
22.6%
14/62 • 5 weeks
|
12.3%
8/65 • 5 weeks
|
|
Psychiatric disorders
Irritability
|
17.7%
11/62 • 5 weeks
|
7.7%
5/65 • 5 weeks
|
|
Psychiatric disorders
Initial insomnia
|
8.1%
5/62 • 5 weeks
|
4.6%
3/65 • 5 weeks
|
|
Psychiatric disorders
Anxiety
|
8.1%
5/62 • 5 weeks
|
0.00%
0/65 • 5 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
48.4%
30/62 • 5 weeks
|
21.5%
14/65 • 5 weeks
|
|
Gastrointestinal disorders
Dry Moutn
|
19.4%
12/62 • 5 weeks
|
1.5%
1/65 • 5 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.1%
5/62 • 5 weeks
|
3.1%
2/65 • 5 weeks
|
|
Nervous system disorders
Headache
|
12.9%
8/62 • 5 weeks
|
6.2%
4/65 • 5 weeks
|
|
Nervous system disorders
Dizzines
|
8.1%
5/62 • 5 weeks
|
1.5%
1/65 • 5 weeks
|
|
General disorders
Fatigue
|
1.6%
1/62 • 5 weeks
|
6.2%
4/65 • 5 weeks
|
|
Cardiac disorders
Tachycardia
|
8.1%
5/62 • 5 weeks
|
0.00%
0/65 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60