Trial Outcomes & Findings for Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine (NCT NCT02571049)
NCT ID: NCT02571049
Last Updated: 2019-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
60 minutes post-treatment
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Sumatriptan 3 mg Then 6 mg
Subjects were first dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) and in the next study visit were dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in another migraine attack (total 6 mg active sumatriptan).
|
Sumatriptan 6 mg Then 3 mg
Subjects were first dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in one migraine attack (total 6 mg active sumatriptan) and in the next study visit were dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) .
|
|---|---|---|
|
Screening
STARTED
|
10
|
14
|
|
Screening
COMPLETED
|
8
|
12
|
|
Screening
NOT COMPLETED
|
2
|
2
|
|
Randomization
STARTED
|
8
|
12
|
|
Randomization
COMPLETED
|
8
|
10
|
|
Randomization
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sumatriptan 3 mg Then 6 mg
Subjects were first dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) and in the next study visit were dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in another migraine attack (total 6 mg active sumatriptan).
|
Sumatriptan 6 mg Then 3 mg
Subjects were first dispensed two sumatriptan 3 mg autoinjectors to self-administer consecutively in one migraine attack (total 6 mg active sumatriptan) and in the next study visit were dispensed one sumatriptan 3 mg autoinjector and one matching placebo autoinjector to self-administer consecutively in one migraine attack (total 3 mg active sumatriptan) .
|
|---|---|---|
|
Screening
Did not meet entry criteria
|
2
|
2
|
|
Randomization
No migraine attack
|
0
|
1
|
|
Randomization
Adverse Event
|
0
|
1
|
Baseline Characteristics
Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
Baseline characteristics by cohort
| Measure |
All Subjects
n=20 Participants
All subjects who were randomized into the study
|
|---|---|
|
Age, Continuous
|
39.80 years
STANDARD_DEVIATION 10.40 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 minutes post-treatmentOutcome measures
| Measure |
Sumatriptan 3 mg
n=18 Participants
DFN-11 active injection and placebo injection
|
Sumatriptan 6 mg
n=19 Participants
Two DFN-11 active injections
|
|---|---|---|
|
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
|
50 Percentage of responders
|
52.63 Percentage of responders
|
Adverse Events
Sumatriptan 3 mg SC
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sumatriptan 6 mg SC
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sumatriptan 3 mg SC
n=20 participants at risk
All subjects who had an AE when treated with sumatriptan 3 mg SC
|
Sumatriptan 6 mg SC
n=20 participants at risk
All subjects who had an AE when treated with sumatriptan 6 mg SC
|
|---|---|---|
|
Nervous system disorders
Paraesthesia
|
25.0%
5/20 • Number of events 5
|
20.0%
4/20 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
4/20 • Number of events 4
|
15.0%
3/20 • Number of events 3
|
|
General disorders
Flushing
|
10.0%
2/20 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Muscle Contraction
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Myalgia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Disorientation
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place