Clinical trial NCT01772524 (phase 1, status: completed)
Conditions: migraine
ICD codes: G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419
Drugs: placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

          -  History of migraine ≥ 12 months with

               -  ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to
                  screening

               -  use of acute migraine medications ≤ 14 days per 28 day period and, within those
                  days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to
                  screening and the 28 day period of completion of eDiary prior to randomization

          -  Women of child-bearing potential and males with partners of child-bearing potential
             must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or
             progestogen, or selective estrogen receptor modulator contraceptive therapeutic,
             intrauterine contraceptive device, or double barrier method [e.g., condom and
             diaphragm or spermicidal gel]). Non-childbearing potential is defined as
             post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least
             3 months before screening

          -  Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is
             stable and ongoing for at least 3 months prior to screening and during the 28 day
             period from screening to randomization

          -  Agree not to post any personal medical data related to the trial or information
             related to the trial on any website or social media site (e.g., Facebook, Twitter)
             until the trial has been completed

        Exclusion Criteria

          -  Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low
             back pain), psychiatric conditions, dementia, or major neurological disorders other
             than migraine that interfere with the participation in the trial

          -  Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache,
             hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial
             hemiplegic migraine

          -  Regular use (greater than 7 days) of prophylactic headache medication (any preventive
             medication or supplement with evidence of efficacy from at least 1 placebo-controlled
             trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or
             during the 28 day period prior to randomization

          -  Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day
             period prior to randomization

          -  Suspected or diagnosis of hypertension with or without antihypertensive treatment

          -  Any ongoing co-morbidity that in the opinion of the Investigator will interfere with
             the participation in the trial

          -  Body Mass Index (BMI) > 39 at screening

          -  Pregnant, breast-feeding, or planning to become pregnant during the trial

          -  Patients who have used opioids > 5 days for the treatment of pain in more than 2 of
             the 6 months prior to screening or in the 28 day period prior to randomization