Trial Outcomes & Findings for Efficacy, Tolerability, and Safety Study of DFN-15 (NCT NCT03006276)
NCT ID: NCT03006276
Last Updated: 2023-01-10
Results Overview
Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
622 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects who received placebo
|
DFN-15
Subjects who received DFN-15
|
|---|---|---|
|
Double-blind Period 1 (DB1)
STARTED
|
311
|
311
|
|
Double-blind Period 1 (DB1)
Not Completed
|
43
|
42
|
|
Double-blind Period 1 (DB1)
COMPLETED
|
266
|
265
|
|
Double-blind Period 1 (DB1)
NOT COMPLETED
|
45
|
46
|
|
Double-blind Period 2 (DB2)
STARTED
|
278
|
267
|
|
Double-blind Period 2 (DB2)
Not Completed
|
16
|
20
|
|
Double-blind Period 2 (DB2)
COMPLETED
|
249
|
242
|
|
Double-blind Period 2 (DB2)
NOT COMPLETED
|
29
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Tolerability, and Safety Study of DFN-15
Baseline characteristics by cohort
| Measure |
DB1 Placebo
n=282 Participants
Subjects received placebo in the Double-blind period 1 (DB1)
|
DB1 DFN-15
n=285 Participants
Subjects received DFN-15 in the Double-blind period 1 (DB1)
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
494 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
243 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
417 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: Full Analysis Set 1
Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=280 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=283 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)
|
21.7 percentage of subjects
Interval 16.8 to 27.1
|
35.6 percentage of subjects
Interval 30.0 to 41.6
|
22.1 percentage of subjects
Interval 17.2 to 27.7
|
35.8 percentage of subjects
Interval 30.1 to 41.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 hours post dosePercentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
Outcome measures
| Measure |
Placebo LOCF
n=232 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=232 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=227 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=228 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
|
44.8 percentage of subjects
Interval 38.3 to 51.5
|
57.8 percentage of subjects
Interval 51.1 to 64.2
|
45.4 percentage of subjects
Interval 38.8 to 52.1
|
58.3 percentage of subjects
Interval 51.6 to 64.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes through 24 hoursThe percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.
Outcome measures
| Measure |
Placebo LOCF
n=151 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=149 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=243 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=238 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
n=203 Participants
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
n=195 Participants
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
n=124 Participants
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
n=108 Participants
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
n=208 Participants
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
n=202 Participants
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
n=157 Participants
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
n=169 Participants
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
24 hours postdose
|
91.4 percentage of subjects
Interval 85.7 to 95.3
|
90.6 percentage of subjects
Interval 84.7 to 94.8
|
85.2 percentage of subjects
Interval 80.1 to 89.4
|
85.7 percentage of subjects
Interval 80.6 to 89.9
|
89.7 percentage of subjects
Interval 84.6 to 93.5
|
85.1 percentage of subjects
Interval 79.3 to 89.8
|
87.1 percentage of subjects
Interval 79.9 to 92.4
|
93.5 percentage of subjects
Interval 87.1 to 97.4
|
84.6 percentage of subjects
Interval 79.0 to 89.2
|
91.6 percentage of subjects
Interval 86.9 to 95.0
|
81.5 percentage of subjects
Interval 74.6 to 87.3
|
90.5 percentage of subjects
Interval 85.1 to 94.5
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
15 minutes postdose
|
16.8 percentage of subjects
Interval 10.8 to 24.3
|
15.7 percentage of subjects
Interval 10.0 to 23.0
|
8.8 percentage of subjects
Interval 5.4 to 13.5
|
9.6 percentage of subjects
Interval 5.9 to 14.4
|
15.7 percentage of subjects
Interval 10.7 to 21.9
|
10.5 percentage of subjects
Interval 6.4 to 16.1
|
14.5 percentage of subjects
Interval 8.5 to 22.5
|
13.7 percentage of subjects
Interval 7.7 to 22.0
|
7.5 percentage of subjects
Interval 4.2 to 12.2
|
8.0 percentage of subjects
Interval 4.6 to 12.9
|
8.5 percentage of subjects
Interval 4.5 to 14.4
|
10.3 percentage of subjects
Interval 6.0 to 16.1
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
30 minutes postdose
|
33.6 percentage of subjects
Interval 25.9 to 41.9
|
32.9 percentage of subjects
Interval 25.3 to 41.1
|
13.0 percentage of subjects
Interval 9.0 to 18.1
|
20.1 percentage of subjects
Interval 15.1 to 25.9
|
26.0 percentage of subjects
Interval 20.0 to 32.9
|
24.6 percentage of subjects
Interval 18.6 to 31.4
|
26.9 percentage of subjects
Interval 19.2 to 35.8
|
31.4 percentage of subjects
Interval 22.7 to 41.2
|
14.4 percentage of subjects
Interval 9.8 to 20.0
|
21.9 percentage of subjects
Interval 16.4 to 28.4
|
15.6 percentage of subjects
Interval 10.2 to 22.3
|
27.4 percentage of subjects
Interval 20.8 to 34.9
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
45 minutes postdose
|
43.8 percentage of subjects
Interval 35.6 to 52.3
|
45.3 percentage of subjects
Interval 37.1 to 53.7
|
20.2 percentage of subjects
Interval 15.2 to 25.9
|
30.6 percentage of subjects
Interval 24.7 to 37.0
|
26.7 percentage of subjects
Interval 20.6 to 33.5
|
35.8 percentage of subjects
Interval 29.0 to 43.0
|
41.8 percentage of subjects
Interval 32.9 to 51.1
|
44.3 percentage of subjects
Interval 34.7 to 54.3
|
22.1 percentage of subjects
Interval 16.6 to 28.4
|
36.2 percentage of subjects
Interval 29.5 to 43.3
|
25.8 percentage of subjects
Interval 19.1 to 33.4
|
38.6 percentage of subjects
Interval 31.1 to 46.4
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
1 hour postdose
|
49.3 percentage of subjects
Interval 41.0 to 57.7
|
56.8 percentage of subjects
Interval 48.4 to 64.9
|
26.5 percentage of subjects
Interval 21.0 to 32.6
|
38.9 percentage of subjects
Interval 32.6 to 45.5
|
38.3 percentage of subjects
Interval 31.4 to 45.5
|
45.0 percentage of subjects
Interval 37.8 to 52.4
|
52.5 percentage of subjects
Interval 43.2 to 61.6
|
51.9 percentage of subjects
Interval 42.0 to 61.7
|
27.9 percentage of subjects
Interval 21.9 to 34.6
|
43.7 percentage of subjects
Interval 36.7 to 50.9
|
34.2 percentage of subjects
Interval 26.8 to 42.2
|
44.0 percentage of subjects
Interval 36.3 to 51.9
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
1.5 hours postdose
|
58.5 percentage of subjects
Interval 50.1 to 66.6
|
63.5 percentage of subjects
Interval 55.2 to 71.3
|
36.0 percentage of subjects
Interval 29.9 to 42.5
|
47.4 percentage of subjects
Interval 40.9 to 54.0
|
47.2 percentage of subjects
Interval 40.1 to 54.4
|
50.8 percentage of subjects
Interval 43.5 to 58.1
|
60.2 percentage of subjects
Interval 50.9 to 68.9
|
67.3 percentage of subjects
Interval 57.5 to 76.0
|
35.4 percentage of subjects
Interval 28.9 to 42.4
|
52.5 percentage of subjects
Interval 45.3 to 59.6
|
43.2 percentage of subjects
Interval 35.3 to 51.4
|
56.3 percentage of subjects
Interval 48.4 to 63.9
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
2 hours postdose
|
62.2 percentage of subjects
Interval 53.8 to 70.0
|
67.6 percentage of subjects
Interval 59.4 to 75.0
|
44.4 percentage of subjects
Interval 37.9 to 50.9
|
58.3 percentage of subjects
Interval 51.7 to 64.7
|
54.5 percentage of subjects
Interval 47.3 to 61.5
|
61.1 percentage of subjects
Interval 53.9 to 68.1
|
66.9 percentage of subjects
Interval 57.9 to 75.1
|
69.2 percentage of subjects
Interval 59.5 to 77.7
|
45.9 percentage of subjects
Interval 39.0 to 52.9
|
64.0 percentage of subjects
Interval 56.9 to 70.6
|
48.7 percentage of subjects
Interval 40.6 to 56.8
|
67.7 percentage of subjects
Interval 60.0 to 74.7
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
4 hours postdose
|
75.5 percentage of subjects
Interval 67.8 to 82.1
|
75.0 percentage of subjects
Interval 67.2 to 81.7
|
61.2 percentage of subjects
Interval 54.7 to 67.3
|
69.9 percentage of subjects
Interval 63.6 to 75.7
|
72.9 percentage of subjects
Interval 66.2 to 78.9
|
71.5 percentage of subjects
Interval 64.6 to 77.8
|
74.2 percentage of subjects
Interval 65.6 to 81.6
|
85.0 percentage of subjects
Interval 76.9 to 91.2
|
62.8 percentage of subjects
Interval 55.8 to 69.4
|
78.1 percentage of subjects
Interval 71.7 to 83.6
|
59.0 percentage of subjects
Interval 50.8 to 66.8
|
76.2 percentage of subjects
Interval 69.0 to 82.4
|
SECONDARY outcome
Timeframe: 2 hours postdoseOutcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Headache Pain Relief Postdose (DB1 and DB2)
|
59.5 minutes
Standard Deviation 29.82
|
68.9 minutes
Standard Deviation 43.67
|
55.3 minutes
Standard Deviation 29.22
|
62.1 minutes
Standard Deviation 29.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours postdoseOutcome measures
| Measure |
Placebo LOCF
n=17 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=27 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=22 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=26 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Headache Pain Freedom Postdose (DB1 and DB2)
|
66.6 minutes
Standard Deviation 32.31
|
68.5 minutes
Standard Deviation 31.01
|
68.8 minutes
Standard Deviation 25.06
|
80.8 minutes
Standard Deviation 25.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdoseHeadache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Relief Postdose (DB1 and DB2)
15 minutes postdose
|
16.6 percentage of subjects
Interval 12.1 to 22.0
|
13.4 percentage of subjects
Interval 9.4 to 18.3
|
10.9 percentage of subjects
Interval 7.1 to 15.8
|
11.7 percentage of subjects
Interval 7.8 to 16.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
30 minutes postdose
|
28.9 percentage of subjects
Interval 23.4 to 34.9
|
32.2 percentage of subjects
Interval 26.6 to 38.2
|
27.5 percentage of subjects
Interval 21.9 to 33.7
|
31.6 percentage of subjects
Interval 25.7 to 38.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
45 minutes postdose
|
40.2 percentage of subjects
Interval 34.2 to 46.5
|
46.5 percentage of subjects
Interval 40.4 to 52.6
|
37.1 percentage of subjects
Interval 31.0 to 43.5
|
47.7 percentage of subjects
Interval 41.2 to 54.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
1 hour postdose
|
45.1 percentage of subjects
Interval 38.9 to 51.4
|
56.8 percentage of subjects
Interval 50.7 to 62.7
|
43.8 percentage of subjects
Interval 37.4 to 50.3
|
56.1 percentage of subjects
Interval 49.5 to 62.5
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
1.5 hours postdose
|
55.2 percentage of subjects
Interval 48.9 to 61.4
|
70.0 percentage of subjects
Interval 64.1 to 75.3
|
53.3 percentage of subjects
Interval 46.8 to 59.7
|
66.4 percentage of subjects
Interval 60.0 to 72.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
2 hours postdose
|
60.5 percentage of subjects
Interval 54.3 to 66.4
|
74.5 percentage of subjects
Interval 69.0 to 79.6
|
60.7 percentage of subjects
Interval 54.2 to 66.8
|
74.4 percentage of subjects
Interval 68.3 to 79.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
4 hours postdose
|
75.2 percentage of subjects
Interval 69.5 to 80.3
|
79.6 percentage of subjects
Interval 74.4 to 84.2
|
75.0 percentage of subjects
Interval 69.1 to 80.3
|
82.2 percentage of subjects
Interval 77.5 to 87.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
24 hours postdose
|
92.5 percentage of subjects
Interval 88.7 to 95.4
|
92.4 percentage of subjects
Interval 88.7 to 95.3
|
89.0 percentage of subjects
Interval 84.4 to 92.6
|
93.8 percentage of subjects
Interval 89.9 to 96.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdosePopulation: Data were not collected at 2 hours postdose during DB1 per protocol
The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Postdose (DB1 and DB2)
24 hours postdose
|
77.2 percentage of subjects
Interval 71.7 to 82.1
|
77.3 percentage of subjects
Interval 72.0 to 82.1
|
75.1 percentage of subjects
Interval 69.2 to 80.4
|
82.9 percentage of subjects
Interval 77.5 to 87.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
15 minutes postdose
|
1.3 percentage of subjects
Interval 0.3 to 3.7
|
0.4 percentage of subjects
Interval 0.0 to 2.2
|
1.4 percentage of subjects
Interval 0.3 to 3.9
|
0.9 percentage of subjects
Interval 0.1 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
30 minutes postdose
|
3.6 percentage of subjects
Interval 1.6 to 6.6
|
3.0 percentage of subjects
Interval 1.3 to 5.8
|
6.4 percentage of subjects
Interval 3.6 to 10.3
|
6.8 percentage of subjects
Interval 4.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
45 minutes postdose
|
8.6 percentage of subjects
Interval 5.5 to 12.7
|
11.1 percentage of subjects
Interval 7.6 to 15.4
|
11.7 percentage of subjects
Interval 7.9 to 16.4
|
12.7 percentage of subjects
Interval 8.7 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
1 hour postdose
|
12.8 percentage of subjects
Interval 9.0 to 17.6
|
17.9 percentage of subjects
Interval 13.6 to 23.0
|
15.8 percentage of subjects
Interval 11.5 to 21.1
|
23.2 percentage of subjects
Interval 18.0 to 29.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
1.5 hours postdose
|
17.4 percentage of subjects
Interval 13.0 to 22.5
|
27.1 percentage of subjects
Interval 21.9 to 32.8
|
25.2 percentage of subjects
Interval 19.9 to 31.2
|
36.1 percentage of subjects
Interval 30.0 to 42.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
2 hours postdose
|
—
|
—
|
31.1 percentage of subjects
Interval 25.4 to 37.4
|
46.2 percentage of subjects
Interval 39.8 to 52.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
4 hours postdose
|
44.4 percentage of subjects
Interval 38.3 to 50.6
|
56.4 percentage of subjects
Interval 50.3 to 62.3
|
50.0 percentage of subjects
Interval 43.6 to 56.4
|
61.9 percentage of subjects
Interval 55.4 to 68.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdoseThe percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
15 minutes postdose
|
10.6 percentage of subjects
Interval 6.8 to 15.6
|
6.3 percentage of subjects
Interval 3.4 to 10.5
|
8.0 percentage of subjects
Interval 4.4 to 13.1
|
8.9 percentage of subjects
Interval 5.2 to 14.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
30 minutes postdose
|
17.4 percentage of subjects
Interval 12.7 to 23.0
|
17.3 percentage of subjects
Interval 12.6 to 22.9
|
15.8 percentage of subjects
Interval 10.9 to 21.8
|
22.9 percentage of subjects
Interval 17.1 to 29.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
45 minutes postdose
|
22.5 percentage of subjects
Interval 17.2 to 28.5
|
28.5 percentage of subjects
Interval 22.7 to 34.8
|
27.5 percentage of subjects
Interval 21.3 to 34.3
|
36.8 percentage of subjects
Interval 30.0 to 44.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
1 hour postdose
|
25.0 percentage of subjects
Interval 19.5 to 31.1
|
39.6 percentage of subjects
Interval 33.2 to 46.2
|
35.8 percentage of subjects
Interval 29.0 to 43.0
|
44.7 percentage of subjects
Interval 37.5 to 52.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
1.5 hours postdose
|
38.7 percentage of subjects
Interval 32.4 to 45.3
|
49.1 percentage of subjects
Interval 42.5 to 55.8
|
42.6 percentage of subjects
Interval 35.5 to 49.8
|
53.4 percentage of subjects
Interval 46.1 to 60.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
2 hours postdose
|
44.8 percentage of subjects
Interval 38.3 to 51.5
|
57.8 percentage of subjects
Interval 51.1 to 64.2
|
50.0 percentage of subjects
Interval 42.8 to 57.2
|
63.4 percentage of subjects
Interval 56.1 to 70.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
4 hours postdose
|
61.3 percentage of subjects
Interval 54.7 to 67.5
|
67.4 percentage of subjects
Interval 61.0 to 73.4
|
60.7 percentage of subjects
Interval 53.5 to 67.6
|
78.0 percentage of subjects
Interval 71.5 to 83.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
24 hours postdose
|
86.0 percentage of subjects
Interval 80.9 to 90.2
|
82.5 percentage of subjects
Interval 77.0 to 87.1
|
83.7 percentage of subjects
Interval 77.7 to 88.6
|
89.6 percentage of subjects
Interval 84.4 to 93.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. A decrease in values indicates improvement from baseline.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
2 hours postdose
|
-0.7 units on a scale
Standard Deviation 0.94
|
-0.9 units on a scale
Standard Deviation 1.00
|
-0.6 units on a scale
Standard Deviation 0.83
|
-0.9 units on a scale
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
4 hours postdose
|
-1.1 units on a scale
Standard Deviation 0.99
|
-1.3 units on a scale
Standard Deviation 1.01
|
-1.0 units on a scale
Standard Deviation 0.95
|
-1.2 units on a scale
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
24 hours postdose
|
-1.8 units on a scale
Standard Deviation 0.82
|
-1.7 units on a scale
Standard Deviation 0.84
|
-1.5 units on a scale
Standard Deviation 0.86
|
-1.5 units on a scale
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 4 hours postdoseThe percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
2 hours postdose
|
19.2 percentage of subjects
Interval 9.6 to 32.5
|
38.0 percentage of subjects
Interval 24.7 to 52.8
|
31.0 percentage of subjects
Interval 17.6 to 47.1
|
54.3 percentage of subjects
Interval 39.0 to 69.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
4 hours postdose
|
45.3 percentage of subjects
Interval 31.6 to 59.6
|
56.0 percentage of subjects
Interval 41.3 to 70.0
|
40.5 percentage of subjects
Interval 25.6 to 56.7
|
56.5 percentage of subjects
Interval 41.1 to 71.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 4 hours postdosePopulation: Subjects were striated by BMI by dosing assignment for DB1 and DB2, therefore subject numbers differ from overall totals.
The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was \<30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
4 hours postdose (BMI <30)
|
41.7 percentage of subjects
Interval 33.8 to 50.0
|
55.9 percentage of subjects
Interval 47.4 to 64.1
|
50.0 percentage of subjects
Interval 41.5 to 58.5
|
67.8 percentage of subjects
Interval 58.6 to 76.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
2 hours postdose (BMI>=30)
|
21.1 percentage of subjects
Interval 14.0 to 29.7
|
40.3 percentage of subjects
Interval 31.8 to 49.3
|
37.3 percentage of subjects
Interval 27.9 to 47.4
|
50.4 percentage of subjects
Interval 41.2 to 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
4 hours postdose (BMI>=30)
|
47.8 percentage of subjects
Interval 38.4 to 57.3
|
56.9 percentage of subjects
Interval 48.0 to 65.6
|
50.0 percentage of subjects
Interval 39.9 to 60.1
|
56.2 percentage of subjects
Interval 46.9 to 65.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
2 hours postdose (BMI<30)
|
22.1 percentage of subjects
Interval 15.8 to 29.7
|
31.5 percentage of subjects
Interval 24.1 to 39.7
|
26.8 percentage of subjects
Interval 19.7 to 34.8
|
41.9 percentage of subjects
Interval 32.8 to 51.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseHeadache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Recurrence Postdose (DB1 and DB2)
|
14.0 percentage of subjects
Interval 6.3 to 25.8
|
9.2 percentage of subjects
Interval 4.3 to 16.7
|
6.6 percentage of subjects
Interval 2.2 to 14.7
|
6.4 percentage of subjects
Interval 2.6 to 12.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseSustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sustained Headache Pain Relief Postdose (DB1 and DB2)
|
43.4 percentage of subjects
Interval 36.6 to 50.4
|
55.1 percentage of subjects
Interval 48.0 to 62.1
|
49.7 percentage of subjects
Interval 42.4 to 57.1
|
60.2 percentage of subjects
Interval 52.8 to 67.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseSustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
|
17.0 percentage of subjects
Interval 12.2 to 22.7
|
26.8 percentage of subjects
Interval 20.9 to 33.4
|
26.5 percentage of subjects
Interval 20.3 to 33.3
|
39.8 percentage of subjects
Interval 32.7 to 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Use of Rescue Medication Postdose (DB1 and DB2)
|
30.1 percentage of subjects
Interval 24.7 to 36.0
|
15.8 percentage of subjects
Interval 11.7 to 20.7
|
18.4 percentage of subjects
Interval 13.7 to 23.8
|
16.7 percentage of subjects
Interval 12.2 to 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 4 hours postdoseSubject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied. A decrease in values indicates improvement from baseline.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=287 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
2 hours postdose
|
3.9 units on a scale
Standard Deviation 1.90
|
3.3 units on a scale
Standard Deviation 1.78
|
3.6 units on a scale
Standard Deviation 1.97
|
3.1 units on a scale
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
4 hours postdose
|
3.7 units on a scale
Standard Deviation 2.05
|
3.2 units on a scale
Standard Deviation 1.90
|
3.5 units on a scale
Standard Deviation 2.06
|
2.9 units on a scale
Standard Deviation 1.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours postdosePatient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items \& 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale \& total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, \& total raw score were summarized by treatment group below.
Outcome measures
| Measure |
Placebo LOCF
n=280 Participants
Placebo - last observation carried forward (LOCF)
|
DFN-15 LOCF
n=283 Participants
DFN-15 - last observation carried forward (LOCF)
|
Placebo OC
n=248 Participants
Placebo - observed cases (OC)
|
DFN-15 OC
n=243 Participants
DFN-15 - observed cases (OC)
|
DB1 Placebo (Phonophobia)
Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB1 DFN-15 (Phonophobia)
DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free
|
DB2 Placebo (Nausea)
Placebo in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 DFN-15 (Nausea)
DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free
|
DB2 Placebo (Photophobia)
Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 DFN-15 (Photophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free
|
DB2 Placebo (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
DB2 DFN-15 (Phonophobia)
DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Total Score
|
-0.657 units on a scale
Standard Deviation 30.9929
|
4.367 units on a scale
Standard Deviation 33.7146
|
3.544 units on a scale
Standard Deviation 32.3791
|
3.940 units on a scale
Standard Deviation 31.7753
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Total Raw Score
|
0.835 units on a scale
Standard Deviation 12.0599
|
-1.254 units on a scale
Standard Deviation 12.9334
|
-0.744 units on a scale
Standard Deviation 12.3973
|
-1.448 units on a scale
Standard Deviation 12.3105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Efficacy
|
-4.196 units on a scale
Standard Deviation 39.0051
|
2.292 units on a scale
Standard Deviation 40.8958
|
0.385 units on a scale
Standard Deviation 39.7293
|
3.604 units on a scale
Standard Deviation 39.9214
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Function
|
-0.020 units on a scale
Standard Deviation 40.3093
|
7.931 units on a scale
Standard Deviation 42.8913
|
6.239 units on a scale
Standard Deviation 39.8213
|
8.169 units on a scale
Standard Deviation 38.6639
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Ease of Use
|
2.247 units on a scale
Standard Deviation 28.5348
|
2.876 units on a scale
Standard Deviation 29.3816
|
4.009 units on a scale
Standard Deviation 28.6588
|
0.047 units on a scale
Standard Deviation 28.8880
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Tolerability
|
5.99 units on a scale
Standard Deviation 16.521
|
8.45 units on a scale
Standard Deviation 15.930
|
9.01 units on a scale
Standard Deviation 15.301
|
6.72 units on a scale
Standard Deviation 15.565
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Medication Effectiveness (Global Item)
|
0.7 units on a scale
Standard Deviation 2.59
|
0.2 units on a scale
Standard Deviation 2.77
|
0.2 units on a scale
Standard Deviation 2.64
|
0.2 units on a scale
Standard Deviation 2.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Side Effects (Global Item)
|
-0.3 units on a scale
Standard Deviation 2.05
|
2.6 units on a scale
Standard Deviation 1.36
|
-0.7 units on a scale
Standard Deviation 1.88
|
-0.3 units on a scale
Standard Deviation 1.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Overall Satisfaction (Global Item)
|
0.5 units on a scale
Standard Deviation 2.67
|
0.1 units on a scale
Standard Deviation 2.75
|
0.1 units on a scale
Standard Deviation 2.62
|
0.0 units on a scale
Standard Deviation 2.48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo DB1
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
DFN-15 DB1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo DB2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DFN-15 DB2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Overall
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo DB1
n=282 participants at risk
TEAEs that occurred following placebo dose in DB1
|
DFN-15 DB1
n=285 participants at risk
TEAEs that occurred following DFN-15 dose in DB1
|
Placebo DB2
n=249 participants at risk
TEAEs that occurred following placebo dose in DB2
|
DFN-15 DB2
n=244 participants at risk
TEAEs that occurred following DFN-15 dose in DB2
|
Overall
n=567 participants at risk
TEAEs that occurred following the first dose of placebo or DFN-15
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
1/282 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/285 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/249 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/244 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.18%
1/567 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
|
Nervous system disorders
Non-cardiac chest pain
|
0.35%
1/282 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/285 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/249 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.00%
0/244 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.18%
1/567 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
Other adverse events
| Measure |
Placebo DB1
n=282 participants at risk
TEAEs that occurred following placebo dose in DB1
|
DFN-15 DB1
n=285 participants at risk
TEAEs that occurred following DFN-15 dose in DB1
|
Placebo DB2
n=249 participants at risk
TEAEs that occurred following placebo dose in DB2
|
DFN-15 DB2
n=244 participants at risk
TEAEs that occurred following DFN-15 dose in DB2
|
Overall
n=567 participants at risk
TEAEs that occurred following the first dose of placebo or DFN-15
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.8%
5/282 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
3.2%
9/285 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
1.2%
3/249 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.82%
2/244 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
3.4%
19/567 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
|
Nervous system disorders
Dysgeusia
|
1.4%
4/282 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
4.2%
12/285 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
0.80%
2/249 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
|
1.6%
4/244 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
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3.9%
22/567 • Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first. For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2. Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.
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Additional Information
Todd Kunkel, PharmD Director, Scientific Communications
BioDelivery Sciences
Phone: 913-940-1789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place