Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
Condition: Migraine; Headaches
MeSH terms: Migraine Disorders; Headache
Intervention: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally; OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Intervention MeSH terms: Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Headaches; Sumatriptan

Summary:

      This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
      the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine
      headaches in 30 minutes after use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman, between the ages of 18 to 65 years, inclusive at screening

          -  Have a diagnosis of episodic migraine, with or without aura according to
             InternationalClassification of Headache Disorders (2nd Edition) (ICHD-2) for at least
             1 year prior to screening

          -  Experiences between 2 and 8 migraine attacks per month for the past 12 months

          -  Women of child bearing potential must be practicing an effective method of birth
             control

          -  Women of child-bearing potential must have a negative urine pregnancy test at the
             screening visit and a negative urine pregnancy test at the randomization visit

          -  Demonstrate the ability to use the bi-directional delivery device correctly

          -  Able and willing to read and comprehend written instructions and complete the
             electronic diary information required by the protocol

          -  Must be capable, in the opinion of the Investigator, of providing informed consent to
             participate in the study. Subjects (and their legally acceptable representatives, if
             applicable) must sign an informed consent document indicating that they understand the
             purpose of and procedures required for the study and are willing to participate in the
             study

        Exclusion Criteria:

          -  Inability to distinguish other headaches from migraine

          -  Experiences headache of any kind at a frequency greater than or equal to 15 days per
             month

          -  History of resistance to sumatriptan, or non-response to 2 or more other triptans,
             defined as subjects who have not responded to an adequate dose and duration of
             treatment

          -  Current use of medication for migraine prophylaxis that has not been stable (no dose
             adjustment) for 30 days prior to screening

          -  Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)

          -  Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks
             before randomization

          -  Have hemiplegic or basilar migraine

          -  History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular
             syndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectoris
             of any type (e.g., stable angina of effort, vasospastic forms of angina such as the
             Prinzmetal variant), all forms of myocardial infarction and silent myocardial
             ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any
             type as well as transient ischemic attacks. Peripheral vascular disease includes, but
             is not limited to, ischemic bowel disease, Raynaud syndrome

          -  Uncontrolled hypertension (screening systolic/diastolic blood pressure >140/95 mmHg)

          -  Have severe hepatic impairment

          -  Have history of epilepsy or conditions associated with a lowered seizure threshold

          -  History (within 2 years) of drug or alcohol abuse as defined by Diagnostic and
             Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria