Trial Outcomes & Findings for The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NCT NCT00724815)
NCT ID: NCT00724815
Last Updated: 2016-02-04
Results Overview
Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
530 participants
Primary outcome timeframe
2 hours post patch activation
Results posted on
2016-02-04
Participant Flow
The study was initiated January 2009 and completed July 2009. Patients were enrolled from 38 investigative sites across the United States.
Participant milestones
| Measure |
NP101 Patch
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Overall Study
STARTED
|
265
|
265
|
|
Overall Study
COMPLETED
|
222
|
226
|
|
Overall Study
NOT COMPLETED
|
43
|
39
|
Reasons for withdrawal
| Measure |
NP101 Patch
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Overall Study
Randomized, not treated
|
31
|
30
|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Other Various
|
3
|
5
|
Baseline Characteristics
The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Baseline characteristics by cohort
| Measure |
NP101 Patch
n=234 Participants
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=235 Participants
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Total
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
233 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=5 Participants
|
235 participants
n=7 Participants
|
469 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post patch activationPopulation: Per protocol, the intent-to-treat population was assessed.
Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.
Outcome measures
| Measure |
NP101 Patch
n=226 Participants
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=228 Participants
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Pain Free at Two Hours
|
40 participants
Interval 1.2 to 3.7
|
21 participants
Interval 1.2 to 3.7
|
SECONDARY outcome
Timeframe: 2 hours post patch activationPopulation: Per protocol, the intent-to-treat population was assessed.
Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.
Outcome measures
| Measure |
NP101 Patch
n=226 Participants
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=228 Participants
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Photophobia Free at Two Hours
|
116 participants
|
83 participants
|
SECONDARY outcome
Timeframe: 2 hours post patch activationPopulation: Per protocol, the intent-to-treat population was assessed.
Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.
Outcome measures
| Measure |
NP101 Patch
n=226 Participants
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=228 Participants
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Phonophobia Free at Two Hours
|
125 participants
|
89 participants
|
SECONDARY outcome
Timeframe: 2 hours post patch activationPopulation: Per protocol, the intent-to-treat population was assessed.
Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.
Outcome measures
| Measure |
NP101 Patch
n=226 Participants
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=228 Participants
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
Nausea Free at Two Hours
|
189 participants
|
144 participants
|
Adverse Events
NP101 Patch
Serious events: 0 serious events
Other events: 114 other events
Deaths: 0 deaths
Placebo Patch
Serious events: 0 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NP101 Patch
n=234 participants at risk
The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
Placebo Patch
n=235 participants at risk
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
|
|---|---|---|
|
General disorders
Application site pain
|
23.1%
54/234 • Number of events 54 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
14.5%
34/235 • Number of events 34 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
|
General disorders
Application site paraesthesia
|
12.0%
28/234 • Number of events 28 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
18.7%
44/235 • Number of events 44 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
|
General disorders
Application site pruritus
|
7.7%
18/234 • Number of events 18 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
6.8%
16/235 • Number of events 16 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
|
General disorders
Application site reaction
|
6.8%
16/234 • Number of events 16 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
5.5%
13/235 • Number of events 13 • All Adverse Events were collected from study screening until 30 days post patch removal.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the study agreement, Investigators have the right to publish or present information and/or data arising from the study, provided the text of any such publication or presentation is submitted for review at least thirty days prior to submission for publication or other disclosure and NuPathe shall have the right to request the removal of any confidential information.
- Publication restrictions are in place
Restriction type: OTHER