Trial Outcomes & Findings for Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD (NCT NCT02096952)
NCT ID: NCT02096952
Last Updated: 2024-07-01
Results Overview
The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54. The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2024-07-01
Participant Flow
Participant milestones
| Measure |
Methylphenidate Extended-release Liquid
Methylphenidate extended-release liquid formulation (MPH-ERLF)
The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability.
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|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Methylphenidate Extended-release Liquid
Methylphenidate extended-release liquid formulation (MPH-ERLF)
The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
Baseline characteristics by cohort
| Measure |
Methylphenidate Extended-release Liquid
n=15 Participants
Methylphenidate extended-release liquid formulation (MPH-ERLF)
The MPH-ERLF was titrated to the target daily dose during the first three weeks of the trial (dose optimization phase) based on a flexible titration schedule as well as tolerability per clinician judgement. Week 3 and onwards, subjects were maintained on maximum achieved dose with a one-time option to decrease the dose of the study medication to the next lowest available dose per clinician judgement based on tolerability.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.9 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksThe Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54. The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.
Outcome measures
| Measure |
Methylphenidate Extended-release Liquid
n=15 Participants
Methylphenidate extended-release liquid formulation
|
|---|---|
|
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
|
-22.8 units on a scale
Standard Deviation 8.8
|
Adverse Events
Methylphenidate Extended-release Liquid
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylphenidate Extended-release Liquid
n=15 participants at risk
Methylphenidate extended-release liquid formulation
|
|---|---|
|
Psychiatric disorders
Suicide attempt
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
Other adverse events
| Measure |
Methylphenidate Extended-release Liquid
n=15 participants at risk
Methylphenidate extended-release liquid formulation
|
|---|---|
|
General disorders
Headache
|
53.3%
8/15 • Number of events 21 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Insomnia
|
33.3%
5/15 • Number of events 11 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Anxiety
|
33.3%
5/15 • Number of events 8 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
4/15 • Number of events 11 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
General disorders
Difficulty falling asleep
|
20.0%
3/15 • Number of events 5 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Irritability
|
20.0%
3/15 • Number of events 3 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Suicidal ideation
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 5 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 4 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Cardiac disorders
Tachycardia
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Blood and lymphatic system disorders
High blood pressure
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
6.7%
1/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
General disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
General disorders
Lightheadedness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Cardiac disorders
Heart racing
|
6.7%
1/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
General disorders
Chest pressure
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 2 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Depressed mood
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Psychiatric disorders
Jittery and tense
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Skin and subcutaneous tissue disorders
Sweaty hands
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Infections and infestations
Flu
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Infections and infestations
Toothache
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
|
Infections and infestations
Sinus issues
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to the study medication (6 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place