Trial · NCT00724815

The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine

NCT00724815, Phase 3, Completed, NuPathe Inc.; results first posted 2013-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine. Trials, record NCT00724815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724815

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
NCT number: NCT00724815
Status: Completed
Phases: Phase 3
Enrollment: 530 participants, actual
Lead sponsor: NuPathe Inc.
Conditions: Migraine Disorders
Interventions: NP101 - Sumatriptan iontophoretic transdermal patch, Placebo
First posted: 2008-07-30
Last updated: 2016-02-04
Results first posted: 2013-05-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pain Free at Two Hours	2 hours post patch activation	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.
Secondary	Photophobia Free at Two Hours	2 hours post patch activation	Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.
Secondary	Phonophobia Free at Two Hours	2 hours post patch activation	Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.
Secondary	Nausea Free at Two Hours	2 hours post patch activation	Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain Free at Two Hours	2 hours post patch activation	Per protocol, the intent-to-treat population was assessed.	participants	NUMBER
SECONDARY	Photophobia Free at Two Hours	2 hours post patch activation	Per protocol, the intent-to-treat population was assessed.	participants	NUMBER
SECONDARY	Phonophobia Free at Two Hours	2 hours post patch activation	Per protocol, the intent-to-treat population was assessed.	participants	NUMBER
SECONDARY	Nausea Free at Two Hours	2 hours post patch activation	Per protocol, the intent-to-treat population was assessed.	participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pain Free at Two Hours	NP101 Patch	40	1.2 to 3.7	participants
Pain Free at Two Hours	Placebo Patch	21	1.2 to 3.7	participants
Photophobia Free at Two Hours	NP101 Patch	116		participants
Photophobia Free at Two Hours	Placebo Patch	83		participants
Phonophobia Free at Two Hours	NP101 Patch	125		participants
Phonophobia Free at Two Hours	Placebo Patch	89		participants
Nausea Free at Two Hours	NP101 Patch	189		participants
Nausea Free at Two Hours	Placebo Patch	144		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NP101 Patch	265
Overall Study	STARTED	Placebo Patch	265
Overall Study	COMPLETED	NP101 Patch	222
Overall Study	COMPLETED	Placebo Patch	226
Overall Study	NOT COMPLETED	NP101 Patch	43
Overall Study	NOT COMPLETED	Placebo Patch	39

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Application site pain	General disorders	NP101 Patch	54	234	54
other	Application site pain	General disorders	Placebo Patch	34	235	34
other	Application site paraesthesia	General disorders	NP101 Patch	28	234	28
other	Application site paraesthesia	General disorders	Placebo Patch	44	235	44
other	Application site pruritus	General disorders	NP101 Patch	18	234	18
other	Application site pruritus	General disorders	Placebo Patch	16	235	16
other	Application site reaction	General disorders	NP101 Patch	16	234	16
other	Application site reaction	General disorders	Placebo Patch	13	235	13

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NP101 Patch
Total, all-cause mortality	Placebo Patch
Total, other adverse events	NP101 Patch	114	234
Total, other adverse events	Placebo Patch	100	235
Total, serious adverse events	NP101 Patch	0	234
Total, serious adverse events	Placebo Patch	0	235

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22694484	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NP101 Patch vs Placebo Patch: Photophobia Free at Two Hours	Trial comparisons
NP101 Patch vs Placebo Patch: Pain Free at Two Hours	Trial comparisons
NP101 Patch vs Placebo Patch: Nausea Free at Two Hours	Trial comparisons
NP101 Patch vs Placebo Patch: Phonophobia Free at Two Hours	Trial comparisons
NP101 Patch vs Placebo Patch: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00724815

GET https://conductscience.org/api/trials/v1/NCT00724815/registered

API reference For AI assistants