Trial Outcomes & Findings for Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (NCT NCT05286762)
NCT ID: NCT05286762
Last Updated: 2026-01-22
Results Overview
The Attention Deficit Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) overall scores range from 0-54; an improvement from Baseline is defined as a decrease in the overall score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
Baseline (Day 0) to Week 5 (Visit 8)
Results posted on
2026-01-22
Participant Flow
Although approximately 385 subjects were expected to enroll in the study, the study was completed with 103 subjects enrolled after an agreement was reached with FDA on the requirements necessary for filing an NDA for CTx-1301. Subjects were recruited at 24 sites from August 1, 2023 to December 13, 2023.
Of the 168 screened subjects, 103 subjects were randomized and received treatment in the study, with a similar number of subjects in each treatment group.
Participant milestones
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
25
|
26
|
|
Overall Study
COMPLETED
|
21
|
24
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
Baseline characteristics by cohort
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
6-12 Years
|
16 Participants
n=270 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
16 Participants
n=220 Participants
|
64 Participants
n=3 Participants
|
|
Age, Customized
13-17 Years
|
10 Participants
n=270 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
10 Participants
n=220 Participants
|
39 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=270 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=220 Participants
|
41 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=270 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
17 Participants
n=220 Participants
|
62 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=220 Participants
|
19 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=270 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
20 Participants
n=220 Participants
|
84 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=270 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=9 Participants
|
13 Participants
n=220 Participants
|
51 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
12 Participants
n=220 Participants
|
45 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=270 Participants
|
26 participants
n=4 Participants
|
25 participants
n=9 Participants
|
26 participants
n=220 Participants
|
103 participants
n=3 Participants
|
|
BMI Z-Score
|
0.413 Z-Score
STANDARD_DEVIATION 0.8340 • n=270 Participants
|
0.221 Z-Score
STANDARD_DEVIATION 1.0205 • n=4 Participants
|
0.314 Z-Score
STANDARD_DEVIATION 1.1993 • n=9 Participants
|
0.315 Z-Score
STANDARD_DEVIATION 0.9324 • n=220 Participants
|
0.315 Z-Score
STANDARD_DEVIATION 0.9909 • n=3 Participants
|
|
BMI Percentile
|
62.84 Percentile
STANDARD_DEVIATION 27.212 • n=270 Participants
|
56.31 Percentile
STANDARD_DEVIATION 31.410 • n=4 Participants
|
62.40 Percentile
STANDARD_DEVIATION 31.393 • n=9 Participants
|
60.18 Percentile
STANDARD_DEVIATION 29.309 • n=220 Participants
|
60.41 Percentile
STANDARD_DEVIATION 29.538 • n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 5 (Visit 8)Population: Summary of observed values and changes from Baseline to Week 5 in the ADHD-RS-5 total score for all subjects (Intent-to-Treat Set).
The Attention Deficit Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) overall scores range from 0-54; an improvement from Baseline is defined as a decrease in the overall score.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=21 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=22 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=20 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=22 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
The Primary Efficacy Analysis Will Analyze the Mean Change From Baseline (Pre-dose) at Visit 2 of Attention Deficit Hyperactivity Disorder Rating Scale 5 (ADHD-RS-5) Scores to ADHD-RS-5 at Visit 8.
|
-18.0 score on a scale
Standard Deviation 12.24
|
-17.8 score on a scale
Standard Deviation 12.78
|
-22.0 score on a scale
Standard Deviation 15.07
|
-8.1 score on a scale
Standard Deviation 13.88
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 5 (Visit 8)Population: Summary of CGI-S score and change from Baseline to Week 5 for all subjects (Intent-to Treat Set)
The Clinical Global Impression - Severity (CGI-S) is a single score ranging from 1-7; an improvement from Baseline is defined as a decrease in the score.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=21 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=22 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=20 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=22 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
The Primary Efficacy Analysis Will Analyze the Mean Change From Baseline (Pre-dose) at Visit 2 of Clinical Global Impression - Severity (CGI-S) Scores to CGI-S at Visit 8.
|
-1.5 score on a scale
Standard Deviation 1.33
|
-1.5 score on a scale
Standard Deviation 1.22
|
-2.2 score on a scale
Standard Deviation 1.57
|
-0.8 score on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline to Visit 8 (5 weeks)Vital signs will be evaluated in each in-office visit; clinically significant changes will be recorded as an adverse event.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in Vital Signs That Resulted in an Adverse Event.
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening to Visit 8 (approximately 5-9 weeks, depending on screening window)Safety labs will be taken at Screening to determine eligibility for entry into the study; safety labs are assessed again at Visit 8 and any clinically significant change from Screening labs will be recorded as an adverse event.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in Blood Labs That Resulted in an Adverse Event.
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Visit 8 (5 weeks)Physical exams will be conducted at Screening, Baseline, and Visit 8. Changes noted as clinically significant from Baseline to Visit 8 will be recorded as an adverse event.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in Physical Exam Findings That Resulted in an Adverse Event.
|
11 Participants
|
14 Participants
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to Visit 8 (5 weeks)Height and Weight (BMI) will be evaluated at all in-office visits. Any clinically significant change in BMI from Baseline to Visit 8 will be recorded as an AE.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in Height and Weight BMI That Resulted in an Adverse Event.
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Visit 8 (5 weeks)C-SSRS will be conducted at all in-office visits. Any clinically significant change from Baseline (at any visit) will be reported as an AE.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in C-SSRS Findings That Resulted in an Adverse Event.
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening to Visit 8 (approximately 5-9 weeks, depending on screening window)ECGs will be taken at Screening to determine eligibility for entry into the study; ECGs are assessed again at Visit 8 and any clinically significant change from Screening ECG will be recorded as an adverse event.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Number of Subjects With Clinically Significant Changes in ECG Findings That Resulted in an Adverse Event.
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening to Visit 9 (approximately 6-10 weeks, depending on screening window)Population: Overall summary of adverse events (Safety Set)
Treatment Emergent Adverse Events will be evaluated at each visit.
Outcome measures
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 Participants
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 Participants
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 Participants
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Safety - Incidence of TEAEs
|
13 Participants
|
9 Participants
|
17 Participants
|
10 Participants
|
Adverse Events
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
25 mg CTx-1301 (Dexmethylphenidate Tablet)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
18.75 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 participants at risk
Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
|
25 mg CTx-1301 (Dexmethylphenidate Tablet)
n=26 participants at risk
Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
|
37.5 mg CTx-1301 (Dexmethylphenidate Tablet)
n=25 participants at risk
Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period.
CTx-1301-Dexmethylphenidate 12.5 mg (titration only): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose): Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
|
Placebo
n=26 participants at risk
Subjects randomized to placebo will be on placebo for the full 5 weeks of the study.
Placebo: Subjects will be randomized at Visit 2 to Placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
General disorders
Chest pain
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
General disorders
Thirst
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Vascular disorders
Prehypertension
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
3/26 • Number of events 3 • Day -30 to Day 42
|
19.2%
5/26 • Number of events 5 • Day -30 to Day 42
|
28.0%
7/25 • Number of events 7 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Cardiac disorders
Tachycardia
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
7.7%
2/26 • Number of events 2 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Investigations
Blood pressure increased
|
3.8%
1/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
8.0%
2/25 • Number of events 3 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Cardiac disorders
Palpitations
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Investigations
Weight decreased
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
8.0%
2/25 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
7.7%
2/26 • Number of events 2 • Day -30 to Day 42
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Infections and infestations
Impetigo
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Infections and infestations
Otitis media
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Infections and infestations
Parotitis
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Psychiatric disorders
Initial insomnia
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26 • Day -30 to Day 42
|
7.7%
2/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Irritability
|
0.00%
0/26 • Day -30 to Day 42
|
7.7%
2/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Aggression
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Major depression
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 3 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
11.5%
3/26 • Number of events 3 • Day -30 to Day 42
|
|
Nervous system disorders
Lethargy
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Nervous system disorders
Tremor
|
0.00%
0/26 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
16.0%
4/25 • Number of events 5 • Day -30 to Day 42
|
7.7%
2/26 • Number of events 2 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 2 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/25 • Day -30 to Day 42
|
3.8%
1/26 • Number of events 1 • Day -30 to Day 42
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
4.0%
1/25 • Number of events 1 • Day -30 to Day 42
|
0.00%
0/26 • Day -30 to Day 42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER