Trial Outcomes & Findings for A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine (NCT NCT00335777)
NCT ID: NCT00335777
Last Updated: 2022-03-11
Results Overview
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
COMPLETED
PHASE4
64 participants
2 hours post treatment with study medication
2022-03-11
Participant Flow
Participants were recruited from our office practice or surrounding community and screened at the Jefferson Headache Center between 8/21/06 and 6/18/08.
Eligible subjects were enrolled in the study and dispensed open label study medication at the end of the screening visit.
Participant milestones
| Measure |
Migranal: All Subjects
All subjects enrolled in study
|
|---|---|
|
Enrolled and Dispensed Study Medication
STARTED
|
64
|
|
Enrolled and Dispensed Study Medication
COMPLETED
|
35
|
|
Enrolled and Dispensed Study Medication
NOT COMPLETED
|
29
|
|
Treated 2 Headaches Per Protocol
STARTED
|
35
|
|
Treated 2 Headaches Per Protocol
COMPLETED
|
22
|
|
Treated 2 Headaches Per Protocol
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Migranal: All Subjects
All subjects enrolled in study
|
|---|---|
|
Enrolled and Dispensed Study Medication
Lost to Follow-up
|
5
|
|
Enrolled and Dispensed Study Medication
Withdrawal by Subject
|
6
|
|
Enrolled and Dispensed Study Medication
Treated only 1 or no headaches
|
18
|
|
Treated 2 Headaches Per Protocol
Treated 2 early or 2 late headaches
|
1
|
|
Treated 2 Headaches Per Protocol
Treated out of protocol for early and late
|
12
|
Baseline Characteristics
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
Baseline characteristics by cohort
| Measure |
Migranal: All Subjects
n=64 Participants
All subjects enrolled in study
|
|---|---|
|
Age, Continuous
|
40.86 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post treatment with study medicationPopulation: Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Outcome measures
| Measure |
Migranal: Early Treatment
n=22 Participants
Treated headache within 1.25 hours of onset of throbbing
|
Migranal Late Treatment
n=22 Participants
Treated a headache at greater or equal to 3.5 hours after onset of throbbing
|
|---|---|---|
|
Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 2 hours post treatment with study medicationPopulation: Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)
Number of subjects who had pain relief at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain relief at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain reduction" is defined as a subject with a 1 or more point decrease on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Outcome measures
| Measure |
Migranal: Early Treatment
n=22 Participants
Treated headache within 1.25 hours of onset of throbbing
|
Migranal Late Treatment
n=22 Participants
Treated a headache at greater or equal to 3.5 hours after onset of throbbing
|
|---|---|---|
|
Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug.
|
14 Participants
|
15 Participants
|
Adverse Events
Migranal: All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Migranal: All Subjects
n=48 participants at risk
All subjects enrolled in study
|
|---|---|
|
General disorders
mouth and throat discomfort
|
6.2%
3/48 • Adverse Events collected from time of dosing through 48 hours post dose.
Adverse Event assessments were performed on all subjects who took any study medication, even if they did not treat according to the guidelines in the protocol. N=48
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
10.4%
5/48 • Adverse Events collected from time of dosing through 48 hours post dose.
Adverse Event assessments were performed on all subjects who took any study medication, even if they did not treat according to the guidelines in the protocol. N=48
|
|
Gastrointestinal disorders
nausea
|
12.5%
6/48 • Adverse Events collected from time of dosing through 48 hours post dose.
Adverse Event assessments were performed on all subjects who took any study medication, even if they did not treat according to the guidelines in the protocol. N=48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place