Clinical trial NCT00724815: The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Official title: The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters.
* Subject is known to be hepatitis B, hepatitis C or HIV positive.
* Subject has hepatic dysfunction based on laboratory results or if in the opinion of the Investigator the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.
* Female subject who is pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing.
* Subject has known history of failure to respond to sumatriptan.
* Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study.
* Subject has been previously enrolled in NP101-007
* Subject is electrically sensitive or who have electrically sensitive support systems (e.g., pacemaker).

Primary outcomes:
measure: Pain Free at Two Hours
timeFrame: 2 hours post patch activation
Secondary outcomes:
measure: Photophobia Free at Two Hours
timeFrame: 2 hours post patch activation
measure: Phonophobia Free at Two Hours
timeFrame: 2 hours post patch activation
measure: Nausea Free at Two Hours
timeFrame: 2 hours post patch activation
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Newport Beach
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Fairfield
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Ann Arbor
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Springfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Mount Vernon
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: West Chester
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: NuPathe Inc.
name: Mark Pierce, MD
role: STUDY_DIRECTOR
References:
citation: 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.