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