Trial Outcomes & Findings for Amiloride Hydrochloride as an Effective Treatment for ADHD (NCT NCT01733680)
NCT ID: NCT01733680
Last Updated: 2018-07-20
Results Overview
CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
3 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-07-20
Participant Flow
Subjects were recruited via a medical clinic and outside advertisement. Due to the stringent inclusion/exclusion criteria, we were only able to recruit 3 subjects and the physician who was conducting the study chose not to continue and we were unable to find another physician.
Participant milestones
| Measure |
Amiloride
Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.
Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.
amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
Placebo
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Amiloride
Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.
Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.
amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
Placebo
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Amiloride Hydrochloride as an Effective Treatment for ADHD
Baseline characteristics by cohort
| Measure |
Arm 1-Amiloride
n=2 Participants
Subjects received amiloride hydrochloride (5 mg for 2 weeks, 10 mg for 3 week, and 15 mg for 3 weeks.
|
Arm 2-Placebo
n=1 Participants
Subjects received placebo for 8 weeks.
|
Total
n=3 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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
CGI
|
4.0 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
4.33 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: There was no statistical analysis done due to the small number of participants in the study
CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse
Outcome measures
| Measure |
Amiloride
n=2 Participants
Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.
Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.
amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
Placebo
n=1 Participants
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
|---|---|---|
|
Improvement in CGI
CGI Week 3
|
4 Units on a scale
Interval 4.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 4
|
4 Units on a scale
Interval 4.0 to 4.0
|
3 Units on a scale
Interval 3.0 to 3.0
|
|
Improvement in CGI
CGI Week 5
|
4 Units on a scale
Interval 4.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 6
|
3.5 Units on a scale
Interval 3.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 7
|
4 Units on a scale
Interval 4.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 8
|
3.5 Units on a scale
Interval 3.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 9
|
3.5 Units on a scale
Interval 3.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
|
Improvement in CGI
CGI Week 10
|
3.5 Units on a scale
Interval 3.0 to 4.0
|
5 Units on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Statistical analysis of the outcome data was not done due to the small N.
An 18 item clinician administered questionnaire to evaluate ADHD in adults. Responses to questions were 0-None, 1-Mild, 2-Moderate, 3-Severe. A decrease of 30% in the total score would be considered improvement. Total score range is 0-54. A lower score indicates improvement in symptoms. A score of 24 or more indicates symptomatic ADHD.
Outcome measures
| Measure |
Amiloride
n=2 Participants
Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.
Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.
amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
Placebo
n=1 Participants
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
|---|---|---|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 3
|
39 Total score
Interval 30.0 to 48.0
|
54 Total score
Interval 54.0 to 54.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 4
|
38.5 Total score
Interval 29.0 to 48.0
|
51 Total score
Interval 51.0 to 51.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 5
|
32.5 Total score
Interval 18.0 to 47.0
|
50 Total score
Interval 50.0 to 50.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 6
|
31 Total score
Interval 20.0 to 42.0
|
50 Total score
Interval 50.0 to 50.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 7
|
31 Total score
Interval 17.0 to 45.0
|
50 Total score
Interval 50.0 to 50.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 8
|
34 Total score
Interval 19.0 to 49.0
|
50 Total score
Interval 50.0 to 50.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 9
|
26 Total score
Interval 14.0 to 38.0
|
50 Total score
Interval 50.0 to 50.0
|
|
AISRS, Adult ADHD Investigator Rating Scale
Week 10
|
32.5 Total score
Interval 20.0 to 45.0
|
50 Total score
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Statistical analysis of the outcome data was not done due to the small N of each group
BRIEF-A is a 75 item self report questionnaire that measures behavior and executive function. For each item the subject is asked "during the past month, how often has each of the following behaviors been a problem?:" The choices are N (never), S (sometimes), O (Often). Total score for the Global Executive Composite used. Raw data were transformed into t-scores, which are standardized scores that indicate the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. Values less than 65 indicate executive function is not a problem and values greater than 65 indicate executive function is often a problem.
Outcome measures
| Measure |
Amiloride
n=2 Participants
Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.
Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.
amiloride: Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
Placebo
n=1 Participants
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
|
|---|---|---|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 3
|
66.5 Global Executive Composite T Score
Interval 63.5 to 69.5
|
95 Global Executive Composite T Score
Interval 92.0 to 98.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 4
|
70.5 Global Executive Composite T Score
Interval 67.5 to 73.5
|
92 Global Executive Composite T Score
Interval 89.0 to 95.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 5
|
68 Global Executive Composite T Score
Interval 65.0 to 71.0
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 6
|
68.5 Global Executive Composite T Score
Interval 65.5 to 71.5
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 7
|
62.5 Global Executive Composite T Score
Interval 59.5 to 65.5
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 8
|
62.5 Global Executive Composite T Score
Interval 59.5 to 65.5
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 9
|
62.5 Global Executive Composite T Score
Interval 59.5 to 65.5
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
|
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Week 10
|
62 Global Executive Composite T Score
Interval 59.0 to 65.0
|
96 Global Executive Composite T Score
Interval 93.0 to 99.0
|
Adverse Events
Amiloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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