Conditions: Migraine Disorders
Keywords: COL-144 acute treatment migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 512
Healthy volunteers: no

Brief 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.

Detailed description:
Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.

Arms:
arm 1: 50 mg lasmiditan administered orally (PO) arm 2: 100 mg lasmiditan administered orally (PO) arm 3: 200 mg lasmiditan administered orally (PO) arm 4: 400 mg lasmiditan administered orally (PO) arm 5: Placebo administered orally (PO)

Interventions: intervention 1: Lasmiditan intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Placebo

Protocol document: