Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.

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

Details

• Lead Sponsor: CoLucid Pharmaceuticals; Eli Lilly and Company
• Collaborators: CoLucid Pharmaceuticals; FGK Clinical Research GmbH
• 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 patients aged 18 to 65 years

• Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)

• Able and willing to give written informed consent

• Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Exclusion Criteria:

• History of life threatening or intolerable adverse reaction to any triptan

• Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation

• Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis

• Using 5-HT reuptake inhibitors

• Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)

• 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)

• History of orthostatic hypotension

• 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 or hepatic 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

• Known Hepatitis B or C or HIV infection

• Patients who are employees of the sponsor

• 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 drug product

• Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)