Trial Outcomes & Findings for An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months (NCT NCT00792103)

Results Overview

For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

198 participants

Primary outcome timeframe

24 hours post patch activation

Results posted on

2016-02-04

Participant Flow

The study was initiated January 2009 and completed in September 2010. Patients were enrolled from 34 investigative sites across the United States.

This was an open-label study to assess the long-term safety of NP101. Subjects who continued to be in good health and received treatment with an NP101 patch for a qualifying migraine in the pivotal NP101-007 study were considered eligible for enrollment.

Participant milestones

Participant milestones
Measure	NP101 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Overall Study STARTED	198
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	133

Reasons for withdrawal

Reasons for withdrawal
Measure	NP101 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Overall Study Enrolled, not treated	15
Overall Study Lost to Follow-up	17
Overall Study Adverse Event	25
Overall Study Withdrawal by Subject	52
Overall Study Protocol Violation	10
Overall Study Did not apply 6 patches in 1st 3 mths	14

Baseline Characteristics

An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NP101 n=183 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	183 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.0 years STANDARD_DEVIATION 10.28 • n=5 Participants
Sex: Female, Male Female	152 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post patch activation

Population: Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).

For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).

Outcome measures

Outcome measures
Measure	NP101 n=1917 NP101 Patches 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Subject Self-examination of Skin Irritation	1.0 scores on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 2 hours

Population: Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.

Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.

Outcome measures

Outcome measures
Measure	NP101 n=181 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Pain Relief	105 participants 0.341

SECONDARY outcome

Timeframe: 2 hours

Population: Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.

Nausea free at two hours after patch activation.

Outcome measures

Outcome measures
Measure	NP101 n=181 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Nausea Free	143 participants

SECONDARY outcome

Timeframe: 2 hours

Population: Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.

Phonophobia free at two hours after patch activation.

Outcome measures

Outcome measures
Measure	NP101 n=181 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Phonophobia Free	109 participants

SECONDARY outcome

Timeframe: 2 hours

Population: Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.

Photophobia free at two hours after patch activation.

Outcome measures

Outcome measures
Measure	NP101 n=181 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Photophobia Free	97 participant

Adverse Events

NP101

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NP101 n=183 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
Ear and labyrinth disorders Vertigo	0.55% 1/183 • Number of events 1 • All adverse events were collected from study enrollment until 30 days after the last patch application.
Metabolism and nutrition disorders Dehydration	0.55% 1/183 • Number of events 1 • All adverse events were collected from study enrollment until 30 days after the last patch application.

Other adverse events

Other adverse events
Measure	NP101 n=183 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 use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
General disorders Application site hypersensitivity	6.0% 11/183 • Number of events 11 • All adverse events were collected from study enrollment until 30 days after the last patch application.
General disorders Application Site Pain	21.3% 39/183 • Number of events 39 • All adverse events were collected from study enrollment until 30 days after the last patch application.
General disorders Application site pruritus	21.9% 40/183 • Number of events 40 • All adverse events were collected from study enrollment until 30 days after the last patch application.

Additional Information

Mark Pierce, MD PhD

NuPathe Inc.

Phone: 484-567-0130

Email: [email protected]

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