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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoLucid Pharmaceuticals; Eli Lilly and Company
• Collaborator: CoLucid Pharmaceuticals
• Treatments: Lasmiditan

Criteria

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