Trial Outcomes & Findings for A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder (NCT NCT03008889)
NCT ID: NCT03008889
Last Updated: 2021-01-26
Results Overview
Goal: randomize 1.75 participants per month
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
12 months (throughout the duration of the study)
Results posted on
2021-01-26
Participant Flow
There were eight consented (or enrolled) participants. Out of the eight participants, one screened failed early, and seven subjects were eligible for the Screening method for classifying self-injurious behavior (SIB) before randomization. Out of those seven, 3 passed screening, and one of the 3 withdrew due to study burden. Two participants were randomized to an intervention (NAC or placebo).
Participant milestones
| Measure |
Participants Taking NAC
Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.
N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.
Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.
N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.
Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8 years
STANDARD_DEVIATION 0 • n=5 Participants
|
9 years
STANDARD_DEVIATION 0 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months (throughout the duration of the study)Goal: randomize 1.75 participants per month
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Percentage of Participants Randomized
|
100 percentage of participants randomized
|
100 percentage of participants randomized
|
PRIMARY outcome
Timeframe: 12 months (throughout the duration of the study)Attrition rate is defined as the percent of subjects who did not complete the study. Goal:less than 15% (to indicate that study was acceptable to participants and parents).
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Attrition Rate
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 12 months (throughout the duration of the study)Goal: at least 70% treatment compliance (tablet counts and drug dairies).
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Study Medication Compliance
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 12 months (throughout the duration of the study)Goal: at least 80% collection of essential outcome data to demonstrate the feasibility of data collection procedures.
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Successful Collection of Outcome Measures
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 9 (at the end of the study intervention)Goal: at least 80% of parents will agree or strongly agree when asked in an anonymous survey that they would recommend the study and the study treatment to other parents of children with ASD and SIB.
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Parent Satisfaction Rating
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months (duration of the study)Population: Screening method for classifying self-injurious behavior (SIB) happened before randomization. Of the 8 participants that consented, one was excluded due to asthma. Results show participants that were classified with repetitive SIB.
Goal: at least 75% positive predictive value of our screening method to classify children with automatically maintained self-injurious behavior using a semi-structured interview at screening compared to the findings of five- to six-hour functional analysis at baseline. Only children who appear to have automatically maintained SIB will be referred for the baseline evaluation. Demonstrating a high positive predictive value for the screening method is a necessary prerequisite for launching a larger study. Using the formula: Positive Predictive Value (PPV) = screen positive and true cases ÷ all positive screens, a value of 75% or greater would indicate success of the screening method used.
Outcome measures
| Measure |
Participants Taking NAC
n=7 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type.
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9The Aberrant Behavior Checklist (ABC) is a commonly used 58-item parent-rated measure of overall behavioral problems. The Irritability subscale is comprised of 15 items reflecting tantrums, aggression and self injury. Range is 0 to 45, higher scores indicate higher severity. As a preliminary efficacy outcome, it was calculated the average score at baseline and Week 9 post-intervention.
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention
Score at Baseline
|
31 score on a scale
|
28 score on a scale
|
|
Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention
Score at 9-Weeks
|
23 score on a scale
|
29 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, Week 9Direct observation of the frequency of SIB was collected at baseline in a separate observational session after completing the functional analysis and again at Week 9. Investigators set a benchmark of an average decline in the frequency of SIB of 50% within the NAC group.
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Number of Self-Injurious Behavior Events
Baseline
|
219 Self injurious events
|
93 Self injurious events
|
|
Number of Self-Injurious Behavior Events
9-Weeks
|
59 Self injurious events
|
655 Self injurious events
|
SECONDARY outcome
Timeframe: Week 9The Clinical Global Impression (CGI-I) scale is a 7-item scale from 1 (Very Much Improved) through 4 (No Change) to 7 (Very Much Worse). By convention, scores of 2 (Much Improved) or 1 (Very Much Improved) are used to define positive response.
Outcome measures
| Measure |
Participants Taking NAC
n=1 Participants
Participants randomized to the active treatment study arm received gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that was used at a higher than usual doses in this study.
N-acetylcysteine: Participants started taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 Participants
Participants randomized to placebo received dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contained inactive ingredients.
Placebo: Participants started taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects returned to the study site to review adverse events. The dosing for the placebo was increased in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose was gradually increased to 900 mg twice per day for study days 8-28.
If this dose was well-tolerated, the dose was increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention
|
2 score on a scale
|
4 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, Week 9Population: Blood samples were collected and processed in accordance with the protocol. In consultation with our biochemist collaborator, we did not proceed with the multiple laboratory procedures to analyze the sample. Our collaborator indicated that the findings would not be interpretable because we only had two subjects.
Changes amino acid levels before and after NAC treatment: cysteine/cystine and glutathione/glutathione disulfide (GSH/GSSG) ratios (antioxidant effects), glutamate and glutamate/glutamine ratio (glutamate signaling) and GABA levels.
Outcome measures
Outcome data not reported
Adverse Events
Participants Taking NAC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants Taking Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Taking NAC
n=1 participants at risk
Participants randomized to the active treatment study arm will receive gradually increasing doses of N-acetylcysteine (NAC) given as a dissolving tablet in juice or water. NAC is an over-the-counter oral dietary supplement that will be used a higher than usual doses in this study.
N-acetylcysteine: Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
Participants Taking Placebo
n=1 participants at risk
Participants randomized to placebo will receive dissolving tablets identical in size and appearance to the active treatment. Placebo capsules contain inactive ingredients.
Placebo: Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.
In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63.
|
|---|---|---|
|
General disorders
Early morning awakening
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
General disorders
Drowsiness
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Infections and infestations
Rhinitis
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Gastrointestinal disorders
Flatulence
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Gastrointestinal disorders
Increased Appetite
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
General disorders
Weight gain
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Psychiatric disorders
Aggression
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
100.0%
1/1 • Number of events 1 • 9 weeks
Each subject was followed by two blinded clinicians. A treating clinician who monitored adverse events and managed the dose of the study medication. An independent evaluator assessed therapeutic response and did not discuss adverse events or medication dose with parent and child.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place