To compare the pharmacokinetics of NP101 with a currently approved oral formulation of
Imitrex® in migraine subjects both during an acute migraine attack and a non-migraine
period.
Inclusion Criteria:
- Adult male and female subjects, between the ages of 18 to 65 years.
- Subjects with a diagnosis of migraine headache, with or without aura, as defined in
the ICHD-II, and the diagnosis was made before the age of 50.
- The majority of a subject's headaches during a migraine attack are moderate to severe
in intensity.
- Subject has history of regulatory occuring migraines, accompanied by nausea.
- Subject has at least one year history of migraine based upon subject testimony.
- Subject will be judged to be in good health, based upon the results of a medical
history, physical examination, vital signs, ECG and laboratory profile.
- Subjects must voluntarily sign and date and Informed Consent agreement approved by an
IRB.
- Subject must have a negative drug screen.
- Female subjects of childbearing potential must have a negative pregnancy test at
Screening and prior to randomization.
Exclusion Criteria:
- Subject has started or changed treatment with prophylactic anti-migraine treatment
within one month of the study randomization date. Subject must agree to not change
treatment with prophylactic anti-migraine medication through End of Study.
- On average, subjects with less than one migraine per month or more than eight
migraines per month or more than fifteen headache days per month for any of the three
months prior to Screening.
- Subject meets cardiovascular criteria as defined.
- Subject with Raynaud's disease.
- Subject with hemiplegic or basilar migraine.
- Subject with a current diagnosis of major depressive disorder.
- Subject who is taking serotonergic drugs including 5-HT agonists, SSRI's, TCAs or
MAOI's.
- Subject is being treated with PD5 Inhibitors.
- Subject who has been treated with ergot medication within two weeks prior to study
entry.
- Subject with a history of significant allergy or hypersensitivity to any component of
the NP101 study patch.
- Subject who has any generalized skin irritation or disease including eczema,
psoriasis, melanoma, acne or contact dermatitis.
- Subject has a positive test result for hepatitis B, hepatitis C or is known to be HIV
positive.
- Subjects with moderate or severe hepatic impairment or, if in the opinion of the
investigator, the subject's history, physical examination or other laboratory tests
suggest hepatic dysfunction.
- Subject with moderate or severe renal impairment.
- Female subjects who are pregnant, breast feeding, or if not 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 final dosing.
- Subjects with a known history of failure to respond to sumatriptan.
- Subject who is considered by the investigator or NuPathe to be an unsuitable candidate
for receiving sumatriptan, or as being unsuitable for any other reason as judged by
the investigator.
- Subject has started or changed treatment of dose of any of the following within 3
months prior to randomization: anxiolytics, lithium and other mood stabilizers.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or
dependence.
- Subject has participated in a clinical study within 30 days of Screening or is
planning to participate in another clinical study.
- Subject is electrically sensitive or who have an implantable electronic device.
