The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
NP101-007
1 other identifier
interventional
530
1 country
34
Brief Summary
This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation. Key secondary objectives included:
- 1.The proportion of subjects who were nausea free at two hours after patch activation.
- 2.The proportion of subjects who were photophobia free at two hours after patch activation.
- 3.The proportion of subjects who were phonophobia free at two hours after patch activation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2009
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 7, 2013
CompletedFebruary 4, 2016
February 1, 2016
6 months
July 28, 2008
February 15, 2013
February 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Free at Two Hours
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.
2 hours post patch activation
Secondary Outcomes (3)
Photophobia Free at Two Hours
2 hours post patch activation
Phonophobia Free at Two Hours
2 hours post patch activation
Nausea Free at Two Hours
2 hours post patch activation
Study Arms (2)
Sumatriptan
EXPERIMENTALNP101 - sumatriptan iontophoretic transdermal patch
Placebo
PLACEBO COMPARATORPlacebo iontophoretic transdermal patch
Interventions
Sumatriptan iontophoretic transdermal patch
Eligibility Criteria
You may qualify if:
- Subject is an adult male or female, age range 18 years to 65 years.
- Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICDH-II and the diagnosis was made before the age of 50.
- Subject typically experiences moderate to severe headaches during a migraine attack.
- Subject has at least a one year history of migraine.
- Subject will be judged to be in good health, based on results of a medical history, physical examination, vital signs, ECG and laboratory profile.
- Female subject of childbearing potential must have a negative pregnancy test at screening and prior to randomization.
- Subject must have a negative drug screen.
- Subject must be capable of reading and understanding either English or Spanish subject information materials. Be able to successfully apply a practice patch, carry-out all subject procedures, and be able to voluntarily sign and date an IRB approved IC agreement.
- Subject has an acceptable patch application site (upper arm) that is relatively hair free and has no scars, tattoos, scratches, or bruises.
You may not qualify if:
- Subject has or plans to start, stop, or change treatment or dose with prophylactic anti-migraine treatment within 3 months prior to the subjects' study randomization date and through the final visit.
- Subject has or plans to start, stop, or change treatment or dose of any of the following within 3 months prior to the subjects' study randomization date through final visit: anxiolytics, lithium and other mood stabilizers, hypnotics or antipsychotics.
- Subject had less than one migraine per month or more than six migraines per month, or more than 15 headache days per month for any of the three months prior to randomization.
- Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
- Subject has Raynaud's disease.
- Subject has a history of basilar or hemiplegic migraines.
- Subject has a current diagnosis of a major depressive disorder per the DSM IV R.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
- Subject is unwilling to discontinue use of serotonin agonists (triptans), except for the study patch, through the Final Visit.
- Subject has taken SSRI's, SNRI's, TCA's, MAOI's or preparations containing St. John's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study.
- Subject is unwilling to discontinue use of a PD-5 inhibitors through the Final Visit.
- Subject has taken ergot medications within 7 days prior to Randomization and/or is unwilling to discontinue use through the Final Visit.
- Subject has a history of a significant allergy or hypersensitivity to any component of the study patch.
- Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, or contact dermatitis.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuPathe Inc.lead
Study Sites (34)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Fairfield, Connecticut, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Palm Beach Gardens, Florida, United States
Unknown Facility
Sunrise, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Savannah, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Mount Vernon, New York, United States
Unknown Facility
Plainview, New York, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
West Chester, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Wynnewood, Pennsylvania, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Alexandria, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Related Publications (1)
Goldstein J, Smith TR, Pugach N, Griesser J, Sebree T, Pierce M. A sumatriptan iontophoretic transdermal system for the acute treatment of migraine. Headache. 2012 Oct;52(9):1402-10. doi: 10.1111/j.1526-4610.2012.02198.x. Epub 2012 Jun 13.
PMID: 22694484DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Pierce, MD, PhD
- Organization
- NuPathe Inc.
Study Officials
- STUDY DIRECTOR
Mark Pierce, MD
NuPathe Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2008
First Posted
July 30, 2008
Study Start
January 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 4, 2016
Results First Posted
May 7, 2013
Record last verified: 2016-02