A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine

Inclusion Criteria: * Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004) * History of migraine of at least 1 year * Migraine onset before the age of 50 years * History of 1 - 8 migraine attacks per month * Male or female subjects aged 18 to 65 years * Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner) * Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache * Able and willing to give written informed consent Exclusion Criteria: * History of life threatening or intolerable adverse reaction to any triptan * Use of prescription migraine prophylactic drugs * Pregnant or breast-feeding women * Women of child-bearing potential not using highly effective contraception * History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures * History of hypertension (controlled or uncontrolled) * Sitting BP \>160mmHg systolic or \>90mmHg diastolic on 2 repeated measurements at screening * Current use of hemodynamically active cardiovascular drugs * History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol * Significant renal impairment * Previous participation in this clinical trial * Participation in any clinical trial of an experimental drug or device in the previous 30 days * Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study * Relatives of, or staff directly reporting to, the investigator * Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144