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

Eli Lilly and Company512 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

512

Conditions

Migraine Disorders

Interventions

LasmiditanDRUG

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.

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (39)

Outcomes

Primary Outcomes

Percentage of Participants With Headache Response

Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.

Time frame: 2 hours postdose

Secondary Outcomes

Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

Time frame: 2 hours post dose

Percentage of Participants With Headache Recurrence

Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.

Time frame: up to 24 hours postdose

Percentage of Participants With Headache Severity (4 Point Rating Scale)

Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.

Time frame: 2 hours postdose

Percentage of Participants Who Have Symptoms of Nausea

Percentage of participants who have symptoms of nausea two hours post treatment.

Time frame: 2 hours postdose

Percentage of Participants Who Have Symptoms Phonophobia

Percentage of participants who have symptoms of phonophobia two hours post treatment.

Time frame: 2 hours postdose

Data from ClinicalTrials.gov

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Montegnée, Liege, Belgium

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Hasselt, Limburg, Belgium

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Leuven, Vlaams-Brabant, Belgium

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Bruges, West-Vlaanderen, Belgium

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Brussels, Belgium

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Liège, Belgium

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Helsinki, Etelä-Suomi, Finland

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Hyvinkää, Etelä-Suomi, Finland

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Mikkeli, Itä-Suomen Lääni, Finland

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Pori, Länsi-Suomen, Finland

...and 29 more locations