Trial Outcomes & Findings for DFN-11 Injection in Episodic Migraine With or Without Aura (NCT NCT02569853)

NCT ID: NCT02569853

Last Updated: 2018-07-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 268 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2018-07-26

Participant Flow

Participant milestones

Measure	DFN-11 - Double-Blind DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-Blind Placebo injection upon occurrence of migraine Placebo
Overall Study STARTED	131	137
Overall Study COMPLETED	111	123
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Measure	DFN-11 - Double-Blind DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-Blind Placebo injection upon occurrence of migraine Placebo
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	3	3
Overall Study Protocol Violation	1	1
Overall Study Did not experience migraine attack	10	7
Overall Study Physician Decision	1	1

Baseline Characteristics

DFN-11 Injection in Episodic Migraine With or Without Aura

Baseline characteristics by cohort

Measure	DFN-11 - Double-blind n=131 Participants DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-blind n=137 Participants Placebo injection upon occurrence of migraine Placebo	Total n=268 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 12.47 • n=5 Participants	40.2 years STANDARD_DEVIATION 12.28 • n=7 Participants	41.0 years STANDARD_DEVIATION 12.38 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	118 Participants n=7 Participants	229 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 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	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	105 Participants n=7 Participants	203 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	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	131 participants n=5 Participants	137 participants n=7 Participants	268 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Subjects analyzed had efficacy data at the time of specified assessment

Outcome measures

Measure	DFN-11 - Double-Blind n=104 Participants DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-Blind n=104 Participants Placebo injection upon occurrence of migraine Placebo
The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary	51.0 Percentage of responders	30.8 Percentage of responders

SECONDARY outcome

Timeframe: 1 hour

Population: Subjects analyzed had efficacy data at the time of specified assessment

Outcome measures

Measure	DFN-11 - Double-Blind n=104 Participants DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-Blind n=101 Participants Placebo injection upon occurrence of migraine Placebo
The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary	34.6 Percentage of responders	19.8 Percentage of responders

Adverse Events

DFN-11 - Double-blind

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo - Double-blind

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DFN-11 - Double-blind n=131 participants at risk DFN-11 active injection upon occurrence of migraine DFN-11	Placebo - Double-blind n=137 participants at risk Placebo injection upon occurrence of migraine Placebo
General disorders Injection site reaction	18.3% 24/131 • Number of events 29 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	10.2% 14/137 • Number of events 18 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
General disorders Paraesthesia	2.3% 3/131 • Number of events 3 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
General disorders Chest discomfort	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	1.5% 2/137 • Number of events 2 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Gastrointestinal disorders Nausea	1.5% 2/131 • Number of events 2 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Respiratory, thoracic and mediastinal disorders Throat tightness	1.5% 2/131 • Number of events 2 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Cardiac disorders Sinus tachycardia	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Cardiac disorders Ventricular extrasystoles	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Gastrointestinal disorders diarrhea	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Gastrointestinal disorders Dysphagia	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).
Infections and infestations Ear infection	0.76% 1/131 • Number of events 1 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).	0.00% 0/137 • During the double-blind treatment period, treatment-emergent adverse events were collected for 5 days after each time a subject treated a migraine with the study drug (DFN-11 or placebo).

Additional Information

Director, Clinical Development

Dr. Reddy's

Phone: 609-375-9900

Email: ebrandschieber@drreddys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place