Trial Outcomes & Findings for DFN-02 Open Label Safety Study in Patients With Acute Migraine (NCT NCT02279082)
NCT ID: NCT02279082
Last Updated: 2018-03-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
6 months
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
DFN-02
Active DFN-02 (Nasal Sumatriptan 10mg)
DFN-02: Active Experimental Drug
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
134
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DFN-02 Open Label Safety Study in Patients With Acute Migraine
Baseline characteristics by cohort
| Measure |
DFN-02 (Single Arm, Open Label)
n=167 Participants
Active DFN-02
DFN-02: Active Experimental Drug
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
167 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
DFN-02
n=167 Participants
Active DFN-02
DFN-02: Active Experimental Drug
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
120 Participants
|
Adverse Events
DFN-02 (Single Arm, Open Label)
Serious events: 4 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFN-02 (Single Arm, Open Label)
n=167 participants at risk
Active DFN-02
DFN-02: Active Experimental Drug
|
|---|---|
|
Gastrointestinal disorders
Diverticulitis
|
0.60%
1/167 • 6 months
|
|
Gastrointestinal disorders
cholecystitis
|
0.60%
1/167 • 6 months
|
|
Reproductive system and breast disorders
menometrorrhagia
|
0.60%
1/167 • 6 months
|
|
Renal and urinary disorders
pyelonephritis
|
0.60%
1/167 • 6 months
|
|
Cardiac disorders
myocardial infarction
|
0.60%
1/167 • 6 months
|
Other adverse events
| Measure |
DFN-02 (Single Arm, Open Label)
n=167 participants at risk
Active DFN-02
DFN-02: Active Experimental Drug
|
|---|---|
|
Nervous system disorders
dysgeusia
|
21.0%
35/167 • Number of events 232 • 6 months
|
|
General disorders
Application site pain
|
30.5%
51/167 • Number of events 568 • 6 months
|
|
General disorders
Application Site Reaction
|
5.4%
9/167 • Number of events 32 • 6 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.8%
18/167 • Number of events 24 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
12/167 • Number of events 13 • 6 months
|
|
Infections and infestations
Sinusitis
|
6.6%
11/167 • Number of events 12 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60