Trial Outcomes & Findings for Study of DA-9801 to Treat Diabetic Neuropathy (NCT NCT01822925)
NCT ID: NCT01822925
Last Updated: 2020-03-20
Results Overview
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
Baseline to 12 weeks of treatment
Results posted on
2020-03-20
Participant Flow
A total of 185 subjects were screened in this study from which, 128 subjects were randomized to the treatment groups, and 57 subjects were categorized as screen failure. Thirty-two (32) subjects were randomized to each of the four (4) study treatment groups: 900 mg DA-9801, 600 mg DA9801, 300 mg DA-9801 and placebo.
Participant milestones
| Measure |
Placebo
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
100 mg oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
200 mg oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
300 mg oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
26
|
30
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
100 mg oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
200 mg oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
300 mg oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
2
|
|
Overall Study
Taking prohibited medication
|
2
|
0
|
0
|
1
|
Baseline Characteristics
Study of DA-9801 to Treat Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
60 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
107 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
32 participants
n=4 Participants
|
128 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
30.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=4 Participants
|
31 kg/m^2
STANDARD_DEVIATION 3.9 • n=21 Participants
|
|
Height
|
68.9 Inches
STANDARD_DEVIATION 4.6 • n=5 Participants
|
69 Inches
STANDARD_DEVIATION 4.5 • n=7 Participants
|
68.9 Inches
STANDARD_DEVIATION 4 • n=5 Participants
|
69.4 Inches
STANDARD_DEVIATION 4.5 • n=4 Participants
|
69 Inches
STANDARD_DEVIATION 4.4 • n=21 Participants
|
|
Weight
|
205 lbs
STANDARD_DEVIATION 41.9 • n=5 Participants
|
207 lbs
STANDARD_DEVIATION 35.4 • n=7 Participants
|
217 lbs
STANDARD_DEVIATION 31.3 • n=5 Participants
|
215 lbs
STANDARD_DEVIATION 41.2 • n=4 Participants
|
211 lbs
STANDARD_DEVIATION 37.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks of treatmentPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
TV 0 (Baseline)
|
6.2 Scores on a scale
Standard Deviation 1.93
|
6.6 Scores on a scale
Standard Deviation 1.43
|
6.6 Scores on a scale
Standard Deviation 1.54
|
6.5 Scores on a scale
Standard Deviation 1.54
|
|
Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
TV 12
|
4 Scores on a scale
Standard Deviation 2.58
|
3.4 Scores on a scale
Standard Deviation 2.49
|
3.5 Scores on a scale
Standard Deviation 2.63
|
3.8 Scores on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: Baseline and over 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Pain intensity was assessed by the subject before any other protocol procedures at baseline and at the 12- week visit using an 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain) (Negative values indicate percentage reductions).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
|
-35.6 Percentage change
Standard Deviation 35.3
|
-45 Percentage change
Standard Deviation 42
|
-47 Percentage change
Standard Deviation 36.5
|
-41.4 Percentage change
Standard Deviation 41.2
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Pain intensity was assessed by the subject before any other protocol procedures at baseline and week 12 based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). The number of participants who had achieved ≥ a 30% reduction in pain from the baseline was to be compared between the treatment groups and placebo.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Number of Participants With at Least 30% Improvement Compared to Baseline as Assessed by the 11- Point Likert Numerical Rating Scale (NRS) at the Week 12 Clinic Visit
|
16 Participants
|
20 Participants
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Average 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7\* \[(Pain Day 1 + Pain Day 2 + …+ Pain Day n)\]/n where n is the number of available diary entries for the week. The minimum pain score for a week would be 0 and the maximum would be 70. Difference in the average weekly pain score at Week 12 is the score for each week minus the baseline .
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Difference in Average Weekly Pain Score Between Dose Groups as Assessed by Daily Diary
|
14.3 Average weekly group pain score
Standard Deviation 13
|
19.8 Average weekly group pain score
Standard Deviation 16.3
|
17.9 Average weekly group pain score
Standard Deviation 18.1
|
15.9 Average weekly group pain score
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Most severe 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly most severe pain scores are defined as 7\* \[(Pain Day 1 + Pain Day 2 + …+ Pain Day n)\]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70. Difference in the average weekly pain score at Week 12 is the score at each week minus baseline .
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Difference in Average Weekly Most Severe Pain Score Between Dose Groups as Assessed by Daily Diary
|
16 weekly most severe pain score
Standard Deviation 14.7
|
23.2 weekly most severe pain score
Standard Deviation 17.3
|
19.7 weekly most severe pain score
Standard Deviation 19.6
|
18.9 weekly most severe pain score
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7\* \[(Pain Day 1 + Pain Day 2 + …+ Pain Day n)\]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70. Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Difference in Average Weekly Overnight Pain Score Between Dose Groups as Assessed by Daily Diary
|
14.3 average weekly overnight pain score
Standard Deviation 14
|
19.9 average weekly overnight pain score
Standard Deviation 16.4
|
19 average weekly overnight pain score
Standard Deviation 18.1
|
16.9 average weekly overnight pain score
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Average weekly pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7\* \[(Pain Day 1 + Pain Day 2 + …+ Pain Day n)\]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70. Difference in the average weekly pain score at Week 12 is the score at each week minus baseline.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary
Baseline
|
42.7 average weekly pain score
Standard Deviation 10.7
|
45.9 average weekly pain score
Standard Deviation 9.1
|
46.3 average weekly pain score
Standard Deviation 10
|
44.2 average weekly pain score
Standard Deviation 11.3
|
|
Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary
Week 12
|
28.3 average weekly pain score
Standard Deviation 16.8
|
26.1 average weekly pain score
Standard Deviation 17.1
|
28.4 average weekly pain score
Standard Deviation 18.1
|
28.3 average weekly pain score
Standard Deviation 18.5
|
|
Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary
Change
|
14.3 average weekly pain score
Standard Deviation 13
|
19.8 average weekly pain score
Standard Deviation 16.3
|
17.9 average weekly pain score
Standard Deviation 18.1
|
15.9 average weekly pain score
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline to 12 week treatment periodPopulation: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7\* \[(Pain Day 1 + Pain Day 2 + …+ Pain Day n)\]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70. Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary
Baseline
|
43.7 average weekly overnight pain score
Standard Deviation 11
|
44.4 average weekly overnight pain score
Standard Deviation 11.8
|
46.5 average weekly overnight pain score
Standard Deviation 9.38
|
46.4 average weekly overnight pain score
Standard Deviation 12.6
|
|
Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary
Week 12
|
29.4 average weekly overnight pain score
Standard Deviation 17
|
24.5 average weekly overnight pain score
Standard Deviation 15.6
|
27.5 average weekly overnight pain score
Standard Deviation 19
|
29.5 average weekly overnight pain score
Standard Deviation 19.4
|
|
Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary
Change
|
14.3 average weekly overnight pain score
Standard Deviation 14
|
19.9 average weekly overnight pain score
Standard Deviation 16.4
|
19 average weekly overnight pain score
Standard Deviation 18.1
|
16.9 average weekly overnight pain score
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
PGI measures the subject's overall improvement in pain. The assessment was to be completed each week during the Treatment Phase. Global impression of improvement was assessed by the subject based on a 7 point scale (1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, 7-very much worse. Responders are defined as subjects with response of "very much improved", "much improved" or "minimally improved"
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Number of Participants Considered to be Responders on Global Impression of Improvement (PGI-I) at Week 12
|
18 Participants
|
20 Participants
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
CGI measures global severity of illness at a given point of time and the improvement from baseline. The assessment was to be completed by the Investigator at baseline and each week during the treatment phase. CGI responders were defined as subjects achieving a score of: (1): Very much improved or (2): Much improved or (3): Minimally improved on the clinician-rated CGI global improvement item.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Number of Participants Number of Participants Considered to be Responders in Clinical Global Impression (CGI) at Week 12
|
19 Participants
|
24 Participants
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 12Population: Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.
During the Treatment Periods, subjects taking 500 mg acetaminophen or Tylenol® for severe pain recorded the frequency and dosage in the daily diary. The use of 500 mg acetaminophen or Tylenol® was recorded for Morning, Afternoon or Evening time. For each subject, the total weekly rescue medication was calculated, and it was used to assess average weekly rescue medication use.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 Participants
Oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Average Weekly Rescue Medication Use
Week 11
|
1266 mg
Standard Deviation 4076
|
891 mg
Standard Deviation 3184
|
109 mg
Standard Deviation 619
|
516 mg
Standard Deviation 2256
|
|
Average Weekly Rescue Medication Use
Week 12
|
1641 mg
Standard Deviation 5448
|
1109 mg
Standard Deviation 3638
|
93.8 mg
Standard Deviation 390
|
344 mg
Standard Deviation 1125
|
|
Average Weekly Rescue Medication Use
Week 4
|
1313 mg
Standard Deviation 4484
|
563 mg
Standard Deviation 1384
|
531 mg
Standard Deviation 1905
|
625 mg
Standard Deviation 1535
|
|
Average Weekly Rescue Medication Use
Week 5
|
1047 mg
Standard Deviation 3817
|
844 mg
Standard Deviation 2807
|
375 mg
Standard Deviation 1621
|
578 mg
Standard Deviation 2703
|
|
Average Weekly Rescue Medication Use
Week 1
|
1688 mg
Standard Deviation 3941
|
1469 mg
Standard Deviation 3617
|
1625 mg
Standard Deviation 4849
|
2141 mg
Standard Deviation 5008
|
|
Average Weekly Rescue Medication Use
Week 2
|
1844 mg
Standard Deviation 4683
|
1547 mg
Standard Deviation 3927
|
2156 mg
Standard Deviation 5566
|
2375 mg
Standard Deviation 5414
|
|
Average Weekly Rescue Medication Use
Week 3
|
1438 mg
Standard Deviation 3656
|
1391 mg
Standard Deviation 4666
|
1188 mg
Standard Deviation 3963
|
1063 mg
Standard Deviation 2602
|
|
Average Weekly Rescue Medication Use
Week 6
|
1078 mg
Standard Deviation 3612
|
859 mg
Standard Deviation 3114
|
172 mg
Standard Deviation 577
|
578 mg
Standard Deviation 2254
|
|
Average Weekly Rescue Medication Use
Week 7
|
1156 mg
Standard Deviation 3775
|
906 mg
Standard Deviation 3254
|
78.1 mg
Standard Deviation 314
|
891 mg
Standard Deviation 2999
|
|
Average Weekly Rescue Medication Use
Week 8
|
1156 mg
Standard Deviation 3971
|
719 mg
Standard Deviation 3976
|
93.8 mg
Standard Deviation 390
|
578 mg
Standard Deviation 1627
|
|
Average Weekly Rescue Medication Use
Week 9
|
1297 mg
Standard Deviation 4275
|
625 mg
Standard Deviation 2362
|
125 mg
Standard Deviation 707
|
500 mg
Standard Deviation 1827
|
|
Average Weekly Rescue Medication Use
Week 10
|
1438 mg
Standard Deviation 4499
|
1281 mg
Standard Deviation 4447
|
93.8 mg
Standard Deviation 530
|
531 mg
Standard Deviation 2359
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
300 mg DA-9801
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
600 mg DA-9801
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
900 mg DA-9801
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 participants at risk
100 mg oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 participants at risk
200 mg oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 participants at risk
300 mg oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Psychiatric disorders
Mania
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Vascular disorders
Peripheral ischaemia
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
Other adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo oral tablets three (3) times per day.
|
300 mg DA-9801
n=32 participants at risk
100 mg oral tablets three (3) times per day for total daily doses of 300 mg
|
600 mg DA-9801
n=32 participants at risk
200 mg oral tablets three (3) times per day for total daily doses of 600 mg
|
900 mg DA-9801
n=32 participants at risk
300 mg oral tablets three (3) times per day for total daily doses of 900 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
12.5%
4/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Gastrointestinal disorders
Oedema peripheral
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.6%
5/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
12.5%
4/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
12.5%
4/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
9.4%
3/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
9.4%
3/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
9.4%
3/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
3.1%
1/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
6.2%
2/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
0.00%
0/32 • Treatment-Emergent Adverse Events (TEAEs) started on or after the first randomized study treatment administration and monitored for 14 weeks through study completion.
|
Additional Information
Vice President Clinical Operations
NeuroBo Pharmaceuticals, Inc.
Phone: 617-313-7331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place