The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: NP101 - Sumatriptan iontophoretic transdermal patch; Placebo
Intervention description: Sumatriptan iontophoretic transdermal patch; NP101 Placebo iontophoretic transdermal patch
Intervention MeSH terms: Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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).