Trial Outcomes & Findings for Pilot Study of DFN-11 Injection in Medication Overuse Headache (NCT NCT02583425)

Last Updated: 2018-04-03

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

28 days Baseline period and 28 days of Treatment period (Total 56 days)

Results posted on

2018-04-03

Participant milestones
Measure	DFN-11 DFN-11 Injection upon occurrence of migraine
Screening STARTED	27
Screening COMPLETED	15
Screening NOT COMPLETED	12
Baseline STARTED	15
Baseline COMPLETED	10
Baseline NOT COMPLETED	5
Treatment Period STARTED	10
Treatment Period COMPLETED	9
Treatment Period NOT COMPLETED	1

Reasons for withdrawal
Measure	DFN-11 DFN-11 Injection upon occurrence of migraine
Screening Did not meet entry criteria	12
Baseline Did not meet continued criteria	5
Treatment Period Adverse Event	1

Pilot Study of DFN-11 Injection in Medication Overuse Headache

Baseline characteristics by cohort
Measure	DFN-11 n=15 Participants DFN-11 Injection upon occurrence of migraine
Age, Continuous	38.6 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 28 days Baseline period and 28 days of Treatment period (Total 56 days)

Outcome measures
Measure	DFN-11 n=9 Participants DFN-11 Injection upon occurrence of migraine headache DFN-11 Injection
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) Baseline period	202.82 Hours Standard Deviation 152.58
The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) Treatment period	138.71 Hours Standard Deviation 113.60

Timeframe: 28 days Baseline period and 28 days of Treatment period (Total 56 days)

Outcome measures
Measure	DFN-11 n=9 Participants DFN-11 Injection upon occurrence of migraine headache DFN-11 Injection
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) Baseline period	16.56 Number of doses of acute medication used Standard Deviation 3.43
The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) Treatment period	19.78 Number of doses of acute medication used Standard Deviation 10.13

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	DFN-11 n=10 participants at risk DFN-11 Injection upon occurrence of migraine
Gastrointestinal disorders Dsypepsia	20.0% 2/10 • Number of events 2
Musculoskeletal and connective tissue disorders Neck pain	20.0% 2/10 • Number of events 3
General disorders Arthralgia	10.0% 1/10 • Number of events 7

Dr. Reddy's

Phone: 609-375-9900