Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

Acute Migraine Clinical Trial

— SAMURAI  

Official title:

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439320
• Other study ID #: 16888
• Secondary ID: H8H-CD-LAHJCOL M
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Description:

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2231
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to give written informed consent.

• Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).

• History of disabling migraine for at least 1 year.

• MIDAS score =11.

• Migraine onset before the age of 50 years.

• History of 3 - 8 migraine attacks per month (< 15 headache days per month).

• Male or female, aged 18 years or above.

• Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).

• Able and willing to complete an electronic diary.

Exclusion Criteria:

• Pregnant or breast-feeding women.

• Women of child-bearing potential not using or not willing to use highly effective contraception.

• Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.

• History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.

• History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.

• History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).

• History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.

• History of orthostatic hypotension with syncope.

• Significant renal or hepatic impairment.

• Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.

• Known Hepatitis B or C or HIV infection.

• History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.

• Use of more than 3 doses per month of either opiates or barbiturates.

• Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• Lasmiditan 100 mg

• Lasmiditan 200 mg

• Placebo (matches lasmiditan doses)

Locations

Country	Name	City	State
United States	Radiant Research,Inc	Akron	Ohio
United States	Family Medical Associates of Texas	Allen	Texas
United States	Primary Care Associates, PA	Anderson	South Carolina
United States	Radiant Research, Inc	Anderson	South Carolina
United States	Radiant Research Inc	Atlanta	Georgia
United States	Mile High Primary Care	Aurora	Colorado
United States	Premier Family Physicians	Austin	Texas
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Simon-Williamson Clinic	Birmingham	Alabama
United States	Southview Medical Group, P.C.	Birmingham	Alabama
United States	Northwest Clinical Trials	Boise	Idaho
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	West Florissant Internists	Bridgeton	Missouri
United States	Meridien Research	Brooksville	Florida
United States	Cassidy Medical Group	Carlsbad	California
United States	East Valley Family Physicians, PC	Chandler	Arizona
United States	Radiant Research,Inc	Chandler	Arizona
United States	Warner Family Practice	Chandler	Arizona
United States	Medical Research South	Charleston	South Carolina
United States	Medical and Procedural Specialists of Illinois	Chicago	Illinois
United States	Michigan Avenue Internists	Chicago	Illinois
United States	Radiant Research, Inc	Chicago	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Clinical Research Advantage Inc/Colorado Springs Family Practice	Colorado Springs	Colorado
United States	Radiant Research, Inc	Columbus	Ohio
United States	Ridge Family Practice	Council Bluffs	Iowa
United States	Radiant Research, Inc	Dallas	Texas
United States	Radiant Research, Inc	Edina	Minnesota
United States	Oklahoma City Clinic - Edmund	Edmond	Oklahoma
United States	Skyline Medical Center	Elkhorn	Nebraska
United States	Evanston Premier Research LLC	Evanston	Illinois
United States	Clinical Research Advantage	Evansville	Indiana
United States	Family Medical Associates	Evansville	Indiana
United States	Clinical Research Advantage/Fountain Hills Family Practice	Fountain Hills	Arizona
United States	Prairie Fields Family Medicine PC	Fremont	Nebraska
United States	Neurological Physicians of Arizona, Inc	Gilbert	Arizona
United States	Lenzmeier Family Practice	Glendale	Arizona
United States	Thunderbird Internal Medicine	Glendale	Arizona
United States	Allied Clinical Research	Gold River	California
United States	Radiant Research, Inc	Greer	South Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Clinical Research Advantage	Henderson	Nevada
United States	James Mell, DO	Henderson	Nevada
United States	Nevada Family Care	Henderson	Nevada
United States	Comprehensive Clinical Development - Queens NY	Jamaica	New York
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Clifford Molin/Clinical Research Advantage,Inc	Las Vegas	Nevada
United States	Diagnostic Center of Medicine	Las Vegas	Nevada
United States	Diagnostic Center of Medicine	Las Vegas	Nevada
United States	Urban Family Practice	Marietta	Georgia
United States	Sunstone Medical Research,LLC	Medford	Oregon
United States	Advanced Clinical Research	Meridian	Idaho
United States	Central Arizona Medical Associates, PC	Mesa	Arizona
United States	Desert Clinical Research	Mesa	Arizona
United States	Suncoast Research Group	Miami	Florida
United States	Oklahoma City Clinic - Midwest CIty	Midwest City	Oklahoma
United States	Radiant Research	Murray	Utah
United States	LION Research	Norman	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma City Clinic- Central/Clinical Research Advantage INC	Oklahoma City	Oklahoma
United States	Southwest Family Physicians, PC	Omaha	Nebraska
United States	CNS Healthcare	Orlando	Florida
United States	Radiant Research Inc./Continuum Health Care	Overland Park	Kansas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Clinical Research Advantage Inc./Central Phoenix Medical Center LLC	Phoenix	Arizona
United States	Family Practice Specialists, Ltd	Phoenix	Arizona
United States	Tatum Highlands Medical Associates, PLLC	Phoenix	Arizona
United States	Thunderbird Internal Medicine	Phoenix	Arizona
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Doctors of Internal Medicine	Plano	Texas
United States	Plano Internal Medicine	Plano	Texas
United States	Village Health Center	Plano	Texas
United States	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon
United States	Radiant Research, Inc	Saint Louis	Missouri
United States	Radiant Research	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Radiant Research, Inc.	Santa Rosa	California
United States	Radiant Research, Inc.	Scottsdale	Arizona
United States	Infinity Clinical Research, LLC	Sunrise	Florida
United States	Georgia Neurology and Sleep Medicine Associates	Suwanee	Georgia
United States	Meridien Research	Tampa	Florida
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Arizona Community Physicians	Tucson	Arizona
United States	Orange Grove Family Practice	Tucson	Arizona
United States	Cassidy Medical Group	Vista	California
United States	West Bay Clinical Research	Warwick	Rhode Island
United States	Comprehensive Clinical Development- Washington DC	Washington	District of Columbia
United States	Heartland Research	Wichita	Kansas
United States	Heartland Research	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	CoLucid Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Resource Utilization	Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study	6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack
Primary	Percentage of Participants Who Are Headache Pain Free	The percentage of participants defined as mild, moderate, or severe headache pain becoming none.	2 hours post dose
Primary	Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.	2 hours post dose
Secondary	Percentage of Participants Who Have Headache Relief After First Dose	The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.	2 hours post dose
Secondary	Percentage of Participants With Headache Recurrence	Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.	From 2 hours post dose up to 48 hours
Secondary	Percentage of Participants Who Used Rescue Medication	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).	2 hours post dose
Secondary	Percentage of Participants Who Used Rescue Medication	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).	Anytime between 2-24 hours post dose
Secondary	Percentage of Participants Who Used Rescue Medication	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).	Anytime 24-48 hours post dose
Secondary	Percentage of Participants Nausea Free	The percentage of participants without nausea.	2 hours post dose
Secondary	Percentage of Participants Phonophobia Free	The percentage of participants without phonophobia.	2 hours post dose
Secondary	Percentage of Participants Photophobia Free	The percentage of participants without photophobia.	2 hours post dose
Secondary	Participants With Serious Adverse Events (SAE)	Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section	Baseline up to 11 weeks