Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.; Placebo
Intervention MeSH terms: Lasmiditan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: COL-144; acute treatment; migraine

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.
    

Eligibility 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)