Clinical trial NCT01253915 (phase 2, status: terminated)
Conditions: migraine
ICD codes: G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419
Drugs: nasal carbon dioxide, placebo
SMILES: O=C=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    low enrollment and lack of funding for study
  
Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Established diagnosis of migraine with or without aura per ICHD-II (patients with a
             diagnosis of only menstrual migraine are not eligible)

          -  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

        Exclusion Criteria:

          -  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

          -  Have participated in another study with nasal CO2