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

Sponsor:	NuPathe Inc.
Information provided by:	NuPathe Inc.
ClinicalTrials.gov Identifier:	NCT00792103

Purpose

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.

Condition	Intervention	Phase
Migraine Disorders	Drug: NP101	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by NuPathe Inc.:

Primary Outcome Measures:

Subject self-examination skin irritation scores [ Time Frame: 4, 6, 12 and 24 hours following patch activation ] [ Designated as safety issue: Yes ]
Adverse event monitoring [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
ECGs [ Time Frame: Enrollment, Month 6 and Month 12 or Final Visit ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: Enrollment, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 or Final Visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Long term efficacy of NP101. [ Time Frame: All initial acute migraine attacks ] [ Designated as safety issue: No ]

Enrollment:	198
Study Start Date:	January 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NP101 sumatriptan iontophoretic transdermal patch	Drug: NP101 NP101 study patch 4 hour application

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine.
Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinically significant abnormal vital signs or ECG parameters in order to qualify for enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final Visit of study NP101-007 was conducted within 30 days.
Female subjects of childbearing potential (not surgically sterile or 2 years post menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

Subject has less than two potential skin application sites.
Subject has clinically significant abnormal vital signs or ECG parameters or had an adverse event while participating in NP101-007 that would preclude the continued treatment with the NP101 patch.
Subject has had changes in their medical history or medication use that would preclude their use of sumatriptan as per the approved Imitrex® product Prescribing Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.
Subject has or plans to start, stop, change treatment or dose of any of the following within 3 months prior to the subject's study Enrollment date and through the Final Visit: anxiolytics, lithium and other mood stabilizers such as valproate, carbamazepine or lamotrigine, hypnotics or antipsychotics.
Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations containing St. John's Wort within 1 month prior to enrollment and/or is planning to start any of these medications during the study (through Final Visit).
Female subjects who are pregnant, breast feeding, or of childbearing potential, and are not using or are unwilling to use an effective form of contraception during the study and for a period of 30 days following Final Visit. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
Subject has participated in a clinical study within 30 days of enrollment (excluding NP101-007) or is planning to participate in another clinical study for the duration of NP101-008.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792103

Show 34 Study Locations

Sponsors and Collaborators

NuPathe Inc.

More Information

No publications provided

Responsible Party:	Angel S. Angelov, MD, Senior Medical Director, NuPathe Inc.
ClinicalTrials.gov Identifier:	NCT00792103 History of Changes
Other Study ID Numbers:	PROT-15-NP101-008
Study First Received:	November 14, 2008
Last Updated:	March 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012