An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: NP101
Intervention description: NP101 study patch 4 hour application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed
      by:

        -  Subject self-examination skin irritation scores

        -  Adverse events

        -  Changes in vital signs and ECG parameters

      The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:

        -  Headache pain free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Headache pain relief at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Nausea free at two hours after patch activation for all initial acute migraine attacks
           treated with NP101

        -  Phonophobia free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Photophobia free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Migraine free at two hours after patch activation for all initial acute migraine attacks
           treated with NP101

      This study will use an open-label design to assess the long term safety of NP101 (sumatriptan
      iontophoretic transdermal patch).

      Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not
      contraindicated) and received treatment (patch activation) with the study patch for a
      qualifying migraine under study NP101-007 will be considered eligible for enrollment into the
      open-label study. Subjects will be expected to remain in the study for up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was previously enrolled in study NP101-007 and treated (patch activation) a
             qualifying migraine.

          -  Subject will be judged to be in good health, based upon the results of a medical
             history, physical examination, vital signs, and ECG. Subjects will not have any
             clinically significant abnormal vital signs or ECG parameters in order to qualify for
             enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final
             Visit of study NP101-007 was conducted within 30 days.

          -  Female subjects of childbearing potential (not surgically sterile or 2 years post
             menopausal) must have a negative pregnancy test at enrollment.

        Exclusion Criteria:

          -  Subject has less than two potential skin application sites.

          -  Subject has clinically significant abnormal vital signs or ECG parameters or had an
             adverse event while participating in NP101-007 that would preclude the continued
             treatment with the NP101 patch.

          -  Subject has had changes in their medical history or medication use that would preclude
             their use of sumatriptan as per the approved Imitrex® product Prescribing Information
             (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.

          -  Subject has or plans to start, stop, change treatment or dose of any of the following
             within 3 months prior to the subject's study Enrollment date and through the Final
             Visit: anxiolytics, lithium and other mood stabilizers such as valproate,
             carbamazepine or lamotrigine, hypnotics or antipsychotics.

          -  Subject has taken non-triptan serotonergic drugs including selective serotonin
             reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI),
             tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations
             containing St. John's Wort within 1 month prior to enrollment and/or is planning to
             start any of these medications during the study (through Final Visit).

          -  Female subjects who are pregnant, breast feeding, or of childbearing potential, and
             are not using or are unwilling to use an effective form of contraception during the
             study and for a period of 30 days following Final Visit. Acceptable methods of
             contraception include barrier method with spermicide, intrauterine device (IUD),
             steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If
             the exclusive male partner is surgically sterile, this will be acceptable.

          -  Subject has participated in a clinical study within 30 days of enrollment (excluding
             NP101-007) or is planning to participate in another clinical study for the duration of
             NP101-008.