Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Capnia, Inc.
With
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
United States Naval Medical Center, Portsmouth
Madigan Army Medical Center
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
Males and females ages 18 - 65 years
You may not be if
At least a one-year history of migraine symptoms with or without aura
Age at migraine onset less than 50 years
History of 2-8 migraine attacks per month during the 3 months prior to randomization
Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile
Have less than 48 hours of freedom from headache between attacks of migraine
Have 15 or more headache days per month
Have migraine secondary to traumatic brain injury (TBI)
Are unable to comply with protocol requirements
Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 7 days after last study drug administration
Have changed their usage of prescription migraine prophylaxis medications within 12 weeks prior to randomization
Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
Have a history of alcohol or drug abuse within 2 years prior to randomization
Have a psychiatric disease which may prevent patient compliance or otherwise interfere with the ability of the patient to participate in the study
Have a medical condition that makes study participation unwise in the opinion of the Investigator (e.g., significant COPD, heart disease, etc.)
Have a concurrent diagnosis of temporomandibular disorders (TMD) or trigeminal neuralgia requiring treatment
Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
Are going to travel extensively by airplane during the 56-day treatment period (e.g., anticipated travel by airplane more than 25% of the 56-day treatment period, 14 days)
Have a member of the same household also participating in this study
Use of any investigational or experimental therapy within 30 days of randomization
