Trial Outcomes & Findings for Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD (NCT NCT03676725)
NCT ID: NCT03676725
Last Updated: 2022-10-06
Results Overview
Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
90 participants
Primary outcome timeframe
30 minute visit, added on to a regular clinic visit
Results posted on
2022-10-06
Participant Flow
Participant milestones
| Measure |
Males Without ADHD
Arm 1
Lidocaine gel: Lidocaine gel 5%
|
Males With ADHD
Arm 2
Lidocaine gel: Lidocaine gel 5%
|
Females Without ADHD and Without PMS
Arm 3
Lidocaine gel: Lidocaine gel 5%
|
Females Without ADHD, But With PMS
Arm 4
Lidocaine gel: Lidocaine gel 5%
|
Females With ADHD and Without PMS
Arm 5
Lidocaine gel: Lidocaine gel 5%
|
Females With ADHD and With PMS
Arm 6
Lidocaine gel: Lidocaine gel 5%
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
14
|
22
|
5
|
15
|
11
|
|
Overall Study
COMPLETED
|
23
|
14
|
22
|
5
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD
Baseline characteristics by cohort
| Measure |
Males Without ADHD
n=23 Participants
ADHD-RS \<18
|
Males With ADHD
n=14 Participants
ADHD-RS ≥18
|
Females Without ADHD and Without PMS
n=22 Participants
ADHD-RS \<18 and Custom PMS \<12
|
Females Without ADHD, But With PMS
n=5 Participants
ADHD-RS \<18 and Custom PMS ≥12
|
Females With ADHD and Without PMS
n=15 Participants
ADHD-RS ≥18 and Custom PMS \<12
|
Females With ADHD and With PMS
n=11 Participants
ADHD-RS ≥18 and Custom PMS ≥12
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
27 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
33 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
33 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
27 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
30 years
STANDARD_DEVIATION 8.1 • n=10 Participants
|
30 years
STANDARD_DEVIATION 7.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 30 minute visit, added on to a regular clinic visitSubjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective.
Outcome measures
| Measure |
Males Without ADHD
n=23 Participants
ADHD-RS \<18
|
Males With ADHD
n=14 Participants
ADHD-RS ≥18
|
Females Without ADHD and Without PMS
n=22 Participants
ADHD-RS \<18 and Custom PMS \<12
|
Females Without ADHD, But With PMS
n=5 Participants
ADHD-RS \<18 and Custom PMS ≥12
|
Females With ADHD and Without PMS
n=15 Participants
ADHD-RS ≥18 and Custom PMS \<12
|
Females With ADHD and With PMS
n=11 Participants
ADHD-RS ≥18 and Custom PMS ≥12
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Lidocaine Ineffectiveness
Lidocaine effective (gets numb)
|
11 Participants
|
9 Participants
|
16 Participants
|
5 Participants
|
15 Participants
|
3 Participants
|
|
Number of Subjects With Lidocaine Ineffectiveness
Lidocaine ineffective (does not get numb)
|
12 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
Adverse Events
All Subjects
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