• - Headache response at two hours after initiation of infusion of study drug
  

• Rates of headache response; Proportion of pts headache free; Rates of sustained response; Rates of sustained pain free; Relief of nausea, vomiting, etc.; Degree of clinical disability; Proportion of pts using rescue medication; Pt global impression
  

This study is set up:

• to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation,
• to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including: headache response, proportion of patients pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting
• to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs
• to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response

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