Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 11:48 PM
Study NCT ID:
NCT00792103
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
Sponsor:
NuPathe Inc.
Organization:
Study Overview
Official Title:
An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NP101-008
Brief Summary:
The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by:
* Subject self-examination skin irritation scores
* Adverse events
* Changes in vital signs and ECG parameters
The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:
* Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101
This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch).
Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.
* Subject self-examination skin irritation scores
* Adverse events
* Changes in vital signs and ECG parameters
The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:
* Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101
This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch).
Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: