This study will use a randomized, parallel group, double-blind, placebo controlled design to
compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch.
Adult subjects who meet the enrollment criteria will be randomized in a 1: 1 ratio and
stratified by race into one of two treatment groups: NP101 - sumatriptan iontophoretic
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.
Exclusion Criteria:
- Subject has started, stopped, changed treatment, or dose with prophylactic
anti-migraine treatment within three months of the study randomization date. Subject
must agree not to start, stop, change treatment, or change dose through Final Visit.
- Subject has started, stopped or changed treatment or dose of any of the following
within 3 months prior to randomization: anxiolytics, lithium and other mood
stabilizers, hypnotics or antipsychotics. Subject must agree not to start, stop,
change treatment or change dose through the Final Visit.
- 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).
