Trial Outcomes & Findings for Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children (NCT NCT04987762)
NCT ID: NCT04987762
Last Updated: 2023-08-22
Results Overview
Adverse events (AEs) were documented and reported from the time the subject/parent(s)/legal guardian provided informed consent/assent up to 7 days after the last study drug administration. AEs that were ongoing at the subject's last study visit were followed until resolution or for 30 days after study drug administration.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2023-08-22
Participant Flow
First subject first visit: August 3, 2021; Last subject last visit: April 27, 2022. Thirteen investigative centers in the United States enrolled participants in the study. The study was terminated early due to administrative reasons unrelated to efficacy or safety.
Participant milestones
| Measure |
Adhansia XR
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
103
|
Reasons for withdrawal
| Measure |
Adhansia XR
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
Overall Study
Study was Terminated by Sponsor
|
103
|
Baseline Characteristics
Age for 1 subject was missing
Baseline characteristics by cohort
| Measure |
Adhansia XR
n=103 Participants
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
Age, Continuous
|
9 years
STANDARD_DEVIATION 2.2 • n=102 Participants • Age for 1 subject was missing
|
|
Sex: Female, Male
Female
|
42 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=103 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=103 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=103 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: The safety analysis population is defined as all subjects who were administered at least 1 dose of study drug and had any safety information.
Adverse events (AEs) were documented and reported from the time the subject/parent(s)/legal guardian provided informed consent/assent up to 7 days after the last study drug administration. AEs that were ongoing at the subject's last study visit were followed until resolution or for 30 days after study drug administration.
Outcome measures
| Measure |
Adhansia XR
n=103 Participants
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
The Number of Participants With Adverse Events as a Measure of Safety
Deaths
|
0 participants
|
|
The Number of Participants With Adverse Events as a Measure of Safety
Serious Adverse Events
|
2 participants
|
|
The Number of Participants With Adverse Events as a Measure of Safety
All Other Adverse Events in ≥ 5% of subjects
|
39 participants
|
Adverse Events
Adhansia XR
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adhansia XR
n=103 participants at risk
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.97%
1/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
|
Gastrointestinal disorders
Constipation
|
0.97%
1/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
Other adverse events
| Measure |
Adhansia XR
n=103 participants at risk
Adhansia XR capsules taken orally once daily in the morning
Adhansia XR: Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
10/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
8/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.5%
17/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
|
Psychiatric disorders
Insomnia
|
17.5%
18/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
|
Psychiatric disorders
Irritability
|
10.7%
11/103 • Documenting and reporting of AEs began when the subject/parent(s)/legal guardian provided informed consent/assent and continued up to 7 days after the last administration of study drug. Adverse events ongoing at the subject's last study visit must have been followed until resolution or for 30 days after study drug administration. Adverse events were collected for up to 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER