Trial Outcomes & Findings for Efficacy, Tolerability, and Safety of DFN-15 (NCT NCT03009019)
NCT ID: NCT03009019
Last Updated: 2023-01-10
Results Overview
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
631 participants
Primary outcome timeframe
2 hours postdose
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
DFN-15
Subjects who received DFN-15 (active study drug)
|
Placebo
Subjects who received placebo equivalent for DFN-15
|
|---|---|---|
|
Double-blind Period 1 (DB1)
STARTED
|
316
|
315
|
|
Double-blind Period 1 (DB1)
COMPLETED
|
280
|
264
|
|
Double-blind Period 1 (DB1)
NOT COMPLETED
|
36
|
51
|
|
Double-blind Period 2 (DB2)
STARTED
|
272
|
273
|
|
Double-blind Period 2 (DB2)
COMPLETED
|
251
|
253
|
|
Double-blind Period 2 (DB2)
NOT COMPLETED
|
21
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Tolerability, and Safety of DFN-15
Baseline characteristics by cohort
| Measure |
DB1 Placebo
n=283 Participants
Subjects received placebo in the Double-blind period 1 (DB1)
|
DB1 DFN-15
n=289 Participants
Subjects received DFN-15 in the Double-blind period 1 (DB1)
|
Total
n=572 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 Years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
41.4 Years
STANDARD_DEVIATION 13.94 • n=7 Participants
|
41.0 Years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
241 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
489 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
423 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
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set 1
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=267 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=256 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=275 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)
|
25.8 percentage of subjects
Interval 20.7 to 31.5
|
32.9 percentage of subjects
Interval 27.4 to 38.7
|
24.6 percentage of subjects
Interval 19.5 to 30.4
|
32.4 percentage of subjects
Interval 26.9 to 38.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 hours postdosePopulation: Full Analysis Set 1
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=272 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=278 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=272 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=278 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
|
45.0 percentage of subjects
Interval 38.5 to 51.7
|
58.9 percentage of subjects
Interval 52.4 to 65.2
|
44.4 percentage of subjects
Interval 37.8 to 51.2
|
58.5 percentage of subjects
Interval 51.9 to 64.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=283 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=289 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=254 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=251 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
|
28 Participants
|
31 Participants
|
26 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdoseThe 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 compared between DFN-15 and placebo
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=147 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=154 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=242 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=245 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
n=206 Participants
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
n=198 Participants
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
n=109 Participants
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
n=120 Participants
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
n=203 Participants
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
n=208 Participants
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
n=170 Participants
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
n=167 Participants
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
24 hours postdose
|
89.1 percentage of subjects
Interval 82.9 to 93.6
|
89.6 percentage of subjects
Interval 83.7 to 93.9
|
83.9 percentage of subjects
Interval 78.6 to 88.3
|
86.5 percentage of subjects
Interval 81.6 to 90.5
|
82.5 percentage of subjects
Interval 76.6 to 87.4
|
88.9 percentage of subjects
Interval 83.7 to 92.9
|
90.8 percentage of subjects
Interval 83.8 to 95.5
|
93.3 percentage of subjects
Interval 87.3 to 97.1
|
85.7 percentage of subjects
Interval 80.1 to 90.2
|
90.4 percentage of subjects
Interval 85.5 to 94.0
|
87.6 percentage of subjects
Interval 81.7 to 92.2
|
89.2 percentage of subjects
Interval 83.5 to 93.5
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
15 minutes postdose
|
20.3 percentage of subjects
Interval 13.7 to 28.3
|
14.3 percentage of subjects
Interval 8.8 to 21.4
|
6.2 percentage of subjects
Interval 3.3 to 10.3
|
9.0 percentage of subjects
Interval 5.5 to 13.6
|
11.1 percentage of subjects
Interval 6.9 to 16.6
|
15.5 percentage of subjects
Interval 10.5 to 21.8
|
10.4 percentage of subjects
Interval 5.1 to 18.3
|
16.2 percentage of subjects
Interval 9.7 to 24.7
|
3.3 percentage of subjects
Interval 1.2 to 7.1
|
10.4 percentage of subjects
Interval 6.4 to 15.8
|
8.7 percentage of subjects
Interval 4.7 to 14.4
|
13.2 percentage of subjects
Interval 8.1 to 19.8
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
30 minutes postdose
|
35.3 percentage of subjects
Interval 27.3 to 43.9
|
32.4 percentage of subjects
Interval 25.0 to 40.6
|
14.7 percentage of subjects
Interval 10.3 to 20.0
|
15.9 percentage of subjects
Interval 11.4 to 21.2
|
16.8 percentage of subjects
Interval 11.8 to 22.8
|
24.5 percentage of subjects
Interval 18.5 to 31.3
|
27.5 percentage of subjects
Interval 19.1 to 37.2
|
27.2 percentage of subjects
Interval 19.3 to 36.3
|
15.0 percentage of subjects
Interval 10.3 to 20.9
|
21.2 percentage of subjects
Interval 15.7 to 27.6
|
19.5 percentage of subjects
Interval 13.6 to 26.5
|
25.9 percentage of subjects
Interval 19.3 to 33.5
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
45 minutes postdose
|
40.3 percentage of subjects
Interval 32.1 to 48.9
|
44.4 percentage of subjects
Interval 36.3 to 52.7
|
22.8 percentage of subjects
Interval 17.5 to 28.8
|
25.2 percentage of subjects
Interval 19.8 to 31.2
|
29.4 percentage of subjects
Interval 23.1 to 36.3
|
33.9 percentage of subjects
Interval 27.2 to 41.0
|
40.4 percentage of subjects
Interval 31.2 to 50.9
|
44.0 percentage of subjects
Interval 34.8 to 53.5
|
25.3 percentage of subjects
Interval 19.3 to 32.0
|
30.2 percentage of subjects
Interval 23.9 to 37.0
|
29.2 percentage of subjects
Interval 22.3 to 36.9
|
36.9 percentage of subjects
Interval 29.4 to 44.9
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
1 hour postdose
|
45.8 percentage of subjects
Interval 37.4 to 54.3
|
55.9 percentage of subjects
Interval 47.6 to 64.0
|
25.9 percentage of subjects
Interval 20.4 to 32.0
|
32.0 percentage of subjects
Interval 26.1 to 38.2
|
32.5 percentage of subjects
Interval 26.0 to 39.5
|
39.5 percentage of subjects
Interval 32.6 to 46.7
|
55.1 percentage of subjects
Interval 45.2 to 65.8
|
56.9 percentage of subjects
Interval 47.4 to 66.1
|
30.8 percentage of subjects
Interval 24.5 to 37.7
|
37.2 percentage of subjects
Interval 30.5 to 44.3
|
38.2 percentage of subjects
Interval 30.7 to 46.1
|
48.1 percentage of subjects
Interval 40.2 to 56.2
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
1.5 hours postdose
|
53.5 percentage of subjects
Interval 45.0 to 61.9
|
58.8 percentage of subjects
Interval 50.6 to 66.7
|
35.6 percentage of subjects
Interval 29.5 to 42.1
|
46.3 percentage of subjects
Interval 39.9 to 52.8
|
40.9 percentage of subjects
Interval 34.0 to 48.1
|
52.0 percentage of subjects
Interval 44.8 to 59.2
|
58.9 percentage of subjects
Interval 49.0 to 68.3
|
62.9 percentage of subjects
Interval 53.5 to 71.7
|
42.2 percentage of subjects
Interval 35.3 to 49.4
|
48.2 percentage of subjects
Interval 41.1 to 55.4
|
52.4 percentage of subjects
Interval 44.5 to 60.2
|
55.6 percentage of subjects
Interval 47.6 to 63.5
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
2 hours postdose
|
60.4 percentage of subjects
Interval 51.9 to 68.5
|
66.7 percentage of subjects
Interval 58.6 to 74.1
|
42.9 percentage of subjects
Interval 36.5 to 49.4
|
58.0 percentage of subjects
Interval 51.5 to 64.3
|
47.0 percentage of subjects
Interval 40.0 to 54.2
|
59.2 percentage of subjects
Interval 52.0 to 66.1
|
68.5 percentage of subjects
Interval 58.9 to 77.1
|
72.9 percentage of subjects
Interval 63.9 to 80.7
|
50.3 percentage of subjects
Interval 43.1 to 57.4
|
53.7 percentage of subjects
Interval 46.6 to 60.7
|
53.9 percentage of subjects
Interval 46.0 to 61.6
|
61.3 percentage of subjects
Interval 53.4 to 68.9
|
|
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
4 hours postdose
|
74.0 percentage of subjects
Interval 66.1 to 80.9
|
83.0 percentage of subjects
Interval 76.1 to 88.6
|
57.5 percentage of subjects
Interval 51.0 to 63.8
|
70.5 percentage of subjects
Interval 64.3 to 76.1
|
65.2 percentage of subjects
Interval 58.2 to 71.7
|
68.5 percentage of subjects
Interval 61.5 to 74.9
|
73.1 percentage of subjects
Interval 63.8 to 81.2
|
84.0 percentage of subjects
Interval 76.2 to 90.1
|
61.0 percentage of subjects
Interval 53.9 to 67.8
|
73.7 percentage of subjects
Interval 67.1 to 79.5
|
69.5 percentage of subjects
Interval 61.9 to 76.3
|
75.8 percentage of subjects
Interval 65.5 to 82.1
|
SECONDARY outcome
Timeframe: 2 hours postdoseThe time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=44 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=34 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=29 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=29 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Headache Pain Relief Postdose (DB1 and DB2)
|
NA time (hours)
Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.
|
NA time (hours)
Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.
|
NA time (hours)
Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.
|
NA time (hours)
Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours postdoseThe time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=26 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=24 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=14 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=24 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Headache Pain Freedom Postdose (DB1 and DB2)
|
NA time (minutes)
Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation
|
NA time (minutes)
Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation
|
NA time (minutes)
Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation
|
NA time (minutes)
Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdoseHeadache pain relief was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time postdose.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Relief Postdose (DB1 and DB2)
15 minutes postdose
|
12.6 percentage of subjects
Interval 8.6 to 17.4
|
12.6 percentage of subjects
Interval 8.7 to 17.3
|
7.9 percentage of subjects
Interval 4.7 to 12.3
|
15.0 percentage of subjects
Interval 10.5 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
30 minutes postdose
|
22.4 percentage of subjects
Interval 17.5 to 28.1
|
25.3 percentage of subjects
Interval 20.2 to 30.9
|
23.0 percentage of subjects
Interval 17.8 to 29.0
|
28.0 percentage of subjects
Interval 22.3 to 34.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
45 minutes postdose
|
35.0 percentage of subjects
Interval 29.2 to 41.2
|
40.0 percentage of subjects
Interval 34.2 to 46.1
|
35.3 percentage of subjects
Interval 29.2 to 41.9
|
40.0 percentage of subjects
Interval 33.7 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
1 hour postdose
|
39.8 percentage of subjects
Interval 33.9 to 46.1
|
49.6 percentage of subjects
Interval 43.6 to 55.7
|
41.9 percentage of subjects
Interval 35.6 to 48.5
|
52.8 percentage of subjects
Interval 46.2 to 59.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
1.5 hours postdose
|
49.6 percentage of subjects
Interval 43.4 to 55.8
|
58.8 percentage of subjects
Interval 52.8 to 64.6
|
51.9 percentage of subjects
Interval 45.3 to 58.4
|
62.7 percentage of subjects
Interval 56.2 to 68.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
2 hours postdose
|
56.9 percentage of subjects
Interval 50.8 to 62.9
|
68.6 percentage of subjects
Interval 62.8 to 74.0
|
58.6 percentage of subjects
Interval 52.0 to 64.9
|
69.6 percentage of subjects
Interval 63.3 to 75.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
4 hours postdose
|
73.8 percentage of subjects
Interval 68.1 to 78.9
|
82.9 percentage of subjects
Interval 78.0 to 87.1
|
74.6 percentage of subjects
Interval 68.6 to 80.0
|
84.7 percentage of subjects
Interval 79.5 to 89.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Relief Postdose (DB1 and DB2)
24 hours postdose
|
92.7 percentage of subjects
Interval 89.0 to 95.5
|
94.3 percentage of subjects
Interval 90.9 to 96.7
|
88.2 percentage of subjects
Interval 83.4 to 91.9
|
95.1 percentage of subjects
Interval 91.6 to 97.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdosePopulation: data for 2 hours postdose were not collected for DB1 per protocol
The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Postdose (DB1 and DB2)
15 minutes postdose
|
2.9 percentage of subjects
Interval 1.2 to 5.9
|
1.2 percentage of subjects
Interval 0.3 to 3.5
|
0.5 percentage of subjects
Interval 0.0 to 2.6
|
2.8 percentage of subjects
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
30 minutes postdose
|
5.5 percentage of subjects
Interval 3.0 to 9.1
|
3.7 percentage of subjects
Interval 1.8 to 6.7
|
1.7 percentage of subjects
Interval 0.5 to 4.4
|
8.6 percentage of subjects
Interval 5.3 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
45 minutes postdose
|
9.7 percentage of subjects
Interval 6.4 to 14.0
|
9.5 percentage of subjects
Interval 6.3 to 13.5
|
7.3 percentage of subjects
Interval 4.3 to 11.5
|
11.9 percentage of subjects
Interval 8.1 to 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
1 hour postdose
|
12.6 percentage of subjects
Interval 8.9 to 17.3
|
18.0 percentage of subjects
Interval 13.7 to 23.0
|
11.9 percentage of subjects
Interval 8.0 to 16.7
|
18.7 percentage of subjects
Interval 13.9 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
1.5 hours postdose
|
19.8 percentage of subjects
Interval 15.2 to 25.2
|
24.7 percentage of subjects
Interval 19.8 to 30.2
|
20.7 percentage of subjects
Interval 15.7 to 26.4
|
27.1 percentage of subjects
Interval 21.6 to 33.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
2 hours postdose
|
—
|
—
|
24.3 percentage of subjects
Interval 19.0 to 30.2
|
36.7 percentage of subjects
Interval 30.6 to 43.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
4 hours postdose
|
40.2 percentage of subjects
Interval 34.3 to 46.3
|
49.1 percentage of subjects
Interval 43.1 to 55.1
|
46.7 percentage of subjects
Interval 40.2 to 53.2
|
59.1 percentage of subjects
Interval 52.6 to 65.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Postdose (DB1 and DB2)
24 hours postdose
|
71.9 percentage of subjects
Interval 66.2 to 77.1
|
79.4 percentage of subjects
Interval 74.2 to 84.0
|
74.7 percentage of subjects
Interval 68.8 to 80.0
|
85.3 percentage of subjects
Interval 80.2 to 89.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes to 24 hours postdoseThe percentage of subjects with their Screening MBS (Most Bothersome Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
2 hours postdose
|
45.0 percentage of subjects
Interval 38.5 to 51.7
|
58.9 percentage of subjects
Interval 52.4 to 65.2
|
51.3 percentage of subjects
Interval 44.0 to 58.6
|
56.9 percentage of subjects
Interval 49.7 to 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
15 minutes postdose
|
8.3 percentage of subjects
Interval 4.9 to 12.9
|
10.4 percentage of subjects
Interval 6.6 to 15.3
|
5.8 percentage of subjects
Interval 2.8 to 10.5
|
9.6 percentage of subjects
Interval 5.7 to 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
30 minutes postdose
|
17.0 percentage of subjects
Interval 12.2 to 22.6
|
18.2 percentage of subjects
Interval 13.4 to 23.8
|
16.4 percentage of subjects
Interval 11.3 to 22.6
|
21.5 percentage of subjects
Interval 15.9 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
45 minutes postdose
|
24.0 percentage of subjects
Interval 18.5 to 30.2
|
29.1 percentage of subjects
Interval 23.4 to 35.3
|
28.1 percentage of subjects
Interval 21.8 to 35.2
|
31.1 percentage of subjects
Interval 24.6 to 38.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
1 hour postdose
|
27.6 percentage of subjects
Interval 21.8 to 33.9
|
36.0 percentage of subjects
Interval 29.9 to 42.4
|
32.3 percentage of subjects
Interval 25.7 to 39.4
|
42.0 percentage of subjects
Interval 34.9 to 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
1.5 hours postdose
|
38.1 percentage of subjects
Interval 31.7 to 44.7
|
48.8 percentage of subjects
Interval 42.3 to 55.3
|
44.7 percentage of subjects
Interval 37.5 to 52.1
|
51.8 percentage of subjects
Interval 44.5 to 59.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
4 hours postdose
|
61.4 percentage of subjects
Interval 54.8 to 67.7
|
70.1 percentage of subjects
Interval 36.9 to 75.8
|
61.5 percentage of subjects
Interval 54.2 to 68.4
|
75.6 percentage of subjects
Interval 69.0 to 81.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
24 hours postdose
|
83.8 percentage of subjects
Interval 78.4 to 88.2
|
86.4 percentage of subjects
Interval 81.4 to 90.4
|
86.7 percentage of subjects
Interval 81.1 to 91.1
|
91.0 percentage of subjects
Interval 86.1 to 94.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseChange in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. The 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 |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
2 hours postdose
|
-0.7 units on a scale
Standard Deviation 0.95
|
-0.9 units on a scale
Standard Deviation 0.89
|
-0.6 units on a scale
Standard Deviation 0.94
|
-0.9 units on a scale
Standard Deviation 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
4 hours postdose
|
-1.0 units on a scale
Standard Deviation 1.06
|
-1.2 units on a scale
Standard Deviation 0.89
|
-0.9 units on a scale
Standard Deviation 0.97
|
-1.2 units on a scale
Standard Deviation 0.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Functional Disability Score Postdose (DB1 and DB2)
24 hours postdose
|
-1.7 units on a scale
Standard Deviation 0.92
|
-1.7 units on a scale
Standard Deviation 0.78
|
-1.5 units on a scale
Standard Deviation 0.84
|
-1.7 units on a scale
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 and 4 hours postdoseThe percentage of subjects who were pain-free at 2 and 4 hours postdose compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
2 hours postdose
|
26.2 percentage of subjects
Interval 16.0 to 38.5
|
26.2 percentage of subjects
Interval 15.8 to 39.1
|
25.5 percentage of subjects
Interval 14.3 to 39.6
|
39.5 percentage of subjects
Interval 25.0 to 55.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
4 hours postdose
|
37.9 percentage of subjects
Interval 26.2 to 50.7
|
39.3 percentage of subjects
Interval 27.1 to 52.7
|
43.1 percentage of subjects
Interval 29.3 to 57.8
|
54.5 percentage of subjects
Interval 38.8 to 69.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 and 4 hours postdosePopulation: Subjects were stratified and data were evaluated by subject BMI, therefore the overall number analyzed differs from the participant numbers reported in the data table.
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, and whose BMI was \< 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
2 hours postdose (BMI<30)
|
22.9 percentage of subjects
Interval 16.3 to 30.7
|
25.6 percentage of subjects
Interval 19.0 to 33.2
|
22.1 percentage of subjects
Interval 15.1 to 30.5
|
34.3 percentage of subjects
Interval 26.5 to 42.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
4 hours postdose (BMI<30)
|
38.1 percentage of subjects
Interval 30.2 to 46.5
|
43.6 percentage of subjects
Interval 35.7 to 51.8
|
44.3 percentage of subjects
Interval 35.3 to 53.5
|
55.0 percentage of subjects
Interval 46.4 to 63.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
2 hours postdose (BMI>=30)
|
29.3 percentage of subjects
Interval 21.4 to 38.1
|
41.9 percentage of subjects
Interval 33.1 to 51.1
|
26.5 percentage of subjects
Interval 18.8 to 35.5
|
40.0 percentage of subjects
Interval 30.3 to 50.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Headache Pain Freedom Among BMI Category (DB1 and DB2)
4 hours postdose (BMI>=30)
|
42.7 percentage of subjects
Interval 33.9 to 51.9
|
56.0 percentage of subjects
Interval 46.8 to 64.9
|
49.2 percentage of subjects
Interval 39.8 to 58.5
|
64.7 percentage of subjects
Interval 54.6 to 73.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain \[mild, moderate, or severe\] reported at 24 hours postdose) compared between DFN-15 and placebo
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Headache Pain Recurrence Postdose (DB1 and DB2)
|
10.1 percentage of subjects
Interval 4.2 to 19.8
|
7.6 percentage of subjects
Interval 3.1 to 15.1
|
6.9 percentage of subjects
Interval 1.9 to 16.7
|
4.5 percentage of subjects
Interval 1.3 to 11.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe percentage of the population of subjects who reported headache pain relief between 2 and 24 hours postdose.
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sustained Headache Pain Relief Postdose (DB1 and DB2)
|
39.8 percentage of subjects
Interval 33.0 to 46.9
|
55.1 percentage of subjects
Interval 48.4 to 61.7
|
44.3 percentage of subjects
Interval 37.0 to 51.8
|
56.6 percentage of subjects
Interval 49.1 to 63.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
|
18.9 percentage of subjects
Interval 13.7 to 25.0
|
27.6 percentage of subjects
Interval 21.8 to 33.9
|
20.0 percentage of subjects
Interval 14.5 to 26.5
|
29.1 percentage of subjects
Interval 22.6 to 36.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 24 hours postdoseThe percentage of subjects who used rescue medication after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period
Outcome measures
| Measure |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Use of Rescue Medication Postdose (DB1 and DB2)
|
28.5 percentage of subjects
Interval 23.2 to 34.2
|
18.8 percentage of subjects
Interval 14.4 to 23.9
|
22.9 percentage of subjects
Interval 17.8 to 28.6
|
18.4 percentage of subjects
Interval 13.7 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 and 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 |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
Difference at 2 hours
|
0.7 units on a scale
Standard Deviation 2.49
|
-0.1 units on a scale
Standard Deviation 2.35
|
0.3 units on a scale
Standard Deviation 2.45
|
-0.1 units on a scale
Standard Deviation 2.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
Difference at 4 hours
|
0.7 units on a scale
Standard Deviation 2.50
|
-0.1 units on a scale
Standard Deviation 2.36
|
0.4 units on a scale
Standard Deviation 2.46
|
-0.1 units on a scale
Standard Deviation 2.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
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 |
DFN-15 Placebo (LOCF)
n=280 Participants
last observation carried forward (LOCF)
|
DFN-15 Active (LOCF)
n=287 Participants
last observation carried forward (LOCF)
|
DFN-15 Placebo (OC)
n=253 Participants
observed cases (OC)
|
DFN-15 Active (OC)
n=250 Participants
observed cases (OC)
|
Placebo DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB1 Phonophobia
Subjects reporting phonophobia at time 0
|
Placebo DB2 Nausea
Subjects reporting nausea at time 0
|
DFN-15 DB2 Nausea
Subjects reporting nausea at time 0
|
Placebo DB2 Photophobia
Subjects reporting photophobia at time 0
|
DFN-15 DB2 Photophobia
Subjects reporting photophobia at time 0
|
Placebo DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
DFN-15 DB2 Phonophobia
Subjects reporting phonophobia at time 0
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Total Score
|
-4.866 units on a scale
Standard Deviation 32.6258
|
5.112 units on a scale
Standard Deviation 30.638
|
0.491 units on a scale
Standard Deviation 32.5487
|
6.691 units on a scale
Standard Deviation 28.1563
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Total Raw Score
|
2.463 units on a scale
Standard Deviation 12.7476
|
-1.498 units on a scale
Standard Deviation 12.0209
|
0.426 units on a scale
Standard Deviation 12.8385
|
-2.312 units on a scale
Standard Deviation 11.0429
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Efficacy
|
-9.591 units on a scale
Standard Deviation 41.0822
|
3.016 units on a scale
Standard Deviation 38.9173
|
-3.261 units on a scale
Standard Deviation 41.6631
|
6.044 units on a scale
Standard Deviation 36.1736
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Function
|
-3.812 units on a scale
Standard Deviation 42.0995
|
8.554 units on a scale
Standard Deviation 39.4248
|
2.559 units on a scale
Standard Deviation 42.3773
|
10.708 units on a scale
Standard Deviation 35.2324
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Ease of Use
|
-1.197 units on a scale
Standard Deviation 29.1309
|
3.766 units on a scale
Standard Deviation 26.0805
|
2.174 units on a scale
Standard Deviation 27.7924
|
3.360 units on a scale
Standard Deviation 23.7033
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Tolerability
|
6.09 units on a scale
Standard Deviation 14.850
|
6.98 units on a scale
Standard Deviation 15.267
|
5.87 units on a scale
Standard Deviation 14.115
|
7.62 units on a scale
Standard Deviation 17.579
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Medication effectiveness (Global Item)
|
0.9 units on a scale
Standard Deviation 2.80
|
0.1 units on a scale
Standard Deviation 2.64
|
0.6 units on a scale
Standard Deviation 2.65
|
-0.1 units on a scale
Standard Deviation 2.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Side Effects (Global Item)
|
-0.5 units on a scale
Standard Deviation 2.00
|
-0.4 units on a scale
Standard Deviation 1.88
|
-0.2 units on a scale
Standard Deviation 1.98
|
-0.5 units on a scale
Standard Deviation 2.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Overall Satisfaction (Global Item)
|
0.8 units on a scale
Standard Deviation 2.74
|
0.1 units on a scale
Standard Deviation 2.60
|
0.5 units on a scale
Standard Deviation 2.65
|
-0.1 units on a scale
Standard Deviation 2.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo DB1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
DFN-15 DB1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo DB2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DFN-15 DB2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Overall
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo DB1
n=283 participants at risk
TEAEs that occurred following placebo dose during DB1
|
DFN-15 DB1
n=289 participants at risk
TEAEs that occurred following DFN-15 dose during DB1
|
Placebo DB2
n=254 participants at risk
TEAEs that occurred following placebo dose during DB2
|
DFN-15 DB2
n=251 participants at risk
TEAEs that occurred following DFN-15 dose during DB2
|
Overall
n=572 participants at risk
TEAEs that occurred following the first dose of placebo or DFN-15
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.35%
1/283 • 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%
0/289 • 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%
0/254 • 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%
0/251 • 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.
|
0.17%
1/572 • 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.
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/283 • 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.
|
0.35%
1/289 • 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%
0/254 • 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%
0/251 • 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.
|
0.17%
1/572 • 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.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/283 • 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%
0/289 • 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%
0/254 • 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.
|
0.40%
1/251 • 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.
|
0.17%
1/572 • 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%
1/283 • 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%
0/289 • 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%
0/254 • 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%
0/251 • 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.
|
0.17%
1/572 • 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=283 participants at risk
TEAEs that occurred following placebo dose during DB1
|
DFN-15 DB1
n=289 participants at risk
TEAEs that occurred following DFN-15 dose during DB1
|
Placebo DB2
n=254 participants at risk
TEAEs that occurred following placebo dose during DB2
|
DFN-15 DB2
n=251 participants at risk
TEAEs that occurred following DFN-15 dose during DB2
|
Overall
n=572 participants at risk
TEAEs that occurred following the first dose of placebo or DFN-15
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.8%
5/283 • 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.
|
1.4%
4/289 • 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%
3/254 • 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%
4/251 • 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.
|
2.3%
13/572 • Number of events 16 • 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.
|
Additional Information
Director, Scientific Communications
BioDelivery Sciences (a subsidiary of Collegium Pharmaceutical)
Phone: 913-940-1789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place