Trial Outcomes & Findings for An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months (NCT NCT00806546)

Last Updated: 2016-02-04

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

514 participants

Primary outcome timeframe

24 hours post patch application

Results posted on

2016-02-04

Participant Flow

The study was initiated March 2009 and completed in May 2011. Patients were enrolled from 34 investigative sites across the United States.

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 mild to 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	514
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	307

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 mild to 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	35
Overall Study Lost to Follow-up	32
Overall Study Adverse Event	74
Overall Study Withdrawal by Subject	75
Overall Study Protocol Violation	49
Overall Study Various	42

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NP101 n=479 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 mild to 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=99 Participants
Age, Categorical Between 18 and 65 years	479 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 11.85 • n=99 Participants
Sex: Female, Male Female	392 Participants n=99 Participants
Sex: Female, Male Male	87 Participants n=99 Participants
Region of Enrollment United States	479 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours post patch application

Population: Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.

Outcome measures

Outcome measures
Measure	NP101 n=7395 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 mild to 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	0.6 scores on a scale Standard Deviation 0.86

Adverse Events

NP101

Serious events: 9 serious events

Other events: 177 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NP101 n=479 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 mild to 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.
Cardiac disorders Atrial fibrillation	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Cardiac disorders Supraventricular tachycardia	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Endocrine disorders Goiter	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Hepatobiliary disorders Bile duct stone	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Hepatobiliary disorders Cholelithiasis	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Musculoskeletal and connective tissue disorders Back pain	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Nervous system disorders Headache	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Nervous system disorders Syncope	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.21% 1/479 • Number of events 1 • All adverse events were collected from Screening until 30 days after the last study visit.

Other adverse events

Other adverse events
Measure	NP101 n=479 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 mild to 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 discoloration	5.8% 28/479 • Number of events 28 • All adverse events were collected from Screening until 30 days after the last study visit.
General disorders Application site dryness	5.6% 27/479 • Number of events 27 • All adverse events were collected from Screening until 30 days after the last study visit.
General disorders Application site pain	19.4% 93/479 • Number of events 93 • All adverse events were collected from Screening until 30 days after the last study visit.
General disorders Application site paraesthesia	5.4% 26/479 • Number of events 26 • All adverse events were collected from Screening until 30 days after the last study visit.
General disorders Application site pruritus	14.0% 67/479 • Number of events 67 • All adverse events were collected from Screening until 30 days after the last study visit.
General disorders Application site reaction	6.1% 29/479 • Number of events 29 • All adverse events were collected from Screening until 30 days after the last study visit.

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 shall 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