Trial Outcomes & Findings for Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD (NCT NCT04167189)
NCT ID: NCT04167189
Last Updated: 2021-07-02
Results Overview
Subjects will be asked to identify each taste and its intensity.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
28 participants
Primary outcome timeframe
on day of testing, approximately 30 minutes for clinic visit
Results posted on
2021-07-02
Participant Flow
Participant milestones
| Measure |
Hard-to-treat ADHD
Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD
Baseline characteristics by cohort
| Measure |
Hard-to-treat ADHD
n=28 Participants
Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
|
|---|---|
|
Age, Continuous
|
16 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 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
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Hard-to-treat ADHD (does not respond to available ADHD drugs)
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on day of testing, approximately 30 minutes for clinic visitPopulation: Study population vs. previously published studies in pediatric populations (Nakai et al, 2000)
Subjects will be asked to identify each taste and its intensity.
Outcome measures
| Measure |
Hard-to-treat ADHD
n=28 Participants
Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack
|
|---|---|
|
Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
Lidocaine effective (got numb)
|
1 Participants
|
|
Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
Lidocaine ineffective (did not get numb)
|
27 Participants
|
Adverse Events
Hard-to-treat ADHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60