Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

Migraine With or Without Aura Clinical Trial

— SPARTAN  

Official title:

A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605174
• Other study ID #: 16889
• Secondary ID: H8H-CD-LAHK2015-
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 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 screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3005
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to give written informed consent and authorize HIPAA.

• 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.

• Migraine Disability Association (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 to record details of the migraine attack treated with study drug.

Exclusion Criteria:

• Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.

• Pregnant or breast-feeding women.

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

• Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.

• 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 Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.

• Previous participation in this clinical trial.

• Participation in any clinical trial of an experimental drug or device in the previous 30 days.

• 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 =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.

• Participants who are employees of the sponsor.

• Relatives of, or staff directly reporting to, the Investigator.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine With or Without Aura

Intervention

Drug:
• Lasmiditan 50 mg
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
• Lasmiditan 100 mg
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
• Lasmiditan 200 mg
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
• Placebo
Two placebo tablets to match lasmiditan doses.

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Anaheim Clinical Trials	Anaheim	California
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Asheville Neurology Specialists, PA	Asheville	North Carolina
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Pinnacle Trials, Inc.	Atlanta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Central Texas Clinical Research, LLC	Austin	Texas
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Nova Clinical Reseach, LLC	Bradenton	Florida
United States	PAB Clinical Research	Brandon	Florida
United States	Meridien Research	Brooksville	Florida
United States	The Research Center of Southern California	Carlsbad	California
United States	PMG Research of Cary, LLC	Cary	North Carolina
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Charlottesville Medical Research, LLC	Charlottesville	Virginia
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	eStudySite	Chula Vista	California
United States	Community Research	Cincinnati	Ohio
United States	IVA Research	Cincinnati	Ohio
United States	Ericksen Research & Development, LLC	Clinton	Utah
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Partners in Clinical Research	Cumberland	Rhode Island
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Lytle and Weiss, PLLC dba Clinical Trials of the Rockies	Denver	Colorado
United States	The Core Research	Doral	Florida
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Clinical Research West Coast	Fort Myers	Florida
United States	Mountain View Clinical Research, Inc.	Greer	South Carolina
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Medical Affiliated Research Center, Inc. - ARC	Huntsville	Alabama
United States	Protenium Clinical Research	Hurst	Texas
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Investigation Specialists Inc	Kenosha	Wisconsin
United States	Holston Medical Group, P.C.	Kingsport	Tennessee
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Associates in Neurology, P.S.C.	Lexington	Kentucky
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	BTC of Lincoln Research,LLC	Lincoln	Rhode Island
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Florida Clinical Research	Maitland	Florida
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Floriday Medical Center and Research, Inc.	Miami	Florida
United States	Pharmax Research Clinic, Inc.	Miami	Florida
United States	Prestige Clinical Research Center, Inc.	Miami	Florida
United States	Veritas Research Corporation	Miami Lakes	Florida
United States	Coastal Carolina Research Center, Inc	Mount Pleasant	South Carolina
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	New Orleans Center for Clinical Research, Inc.	New Orleans	Louisiana
United States	Pharmacology Research Institute, Newport Beach	Newport Beach	California
United States	Harmony Clinical Research Inc.	North Miami Beach	Florida
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Pacific Research Partners	Oakland	California
United States	Adirondack Medical Research Center	Omaha	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Compass Research, LLC	Orlando	Florida
United States	Research Integrity, LLC.	Owensboro	Kentucky
United States	21st Century Neurology	Phoenix	Arizona
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Beacon Clinical Research, LLC	Quincy	Massachusetts
United States	Desert Valley Research	Rancho Mirage	California
United States	Northern California Clinical Research Center	Redding	California
United States	Anderson Clinical Research	Redlands	California
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Rochester Clinical Research Inc.	Rochester	New York
United States	Harbin Clinic, LLC	Rome	Georgia
United States	Clinical Research Center, LLC	Royal Palm Beach	Florida
United States	Meridien Research, Inc.	Saint Petersburg	Florida
United States	J. Lewis Research Inc.- Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research, Inc. Foothill Family Clinic	Salt Lake City	Utah
United States	Jean Brown Research	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Neurological Research Institute	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Schuster Medical Research Institute	Sherman Oaks	California
United States	J. Lewis Research, Inc. - Jordan River Family Medicine	South Jordan	Utah
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Encompass Clinical Research	Spring Valley	California
United States	MultiCare Health System Institute for Research and Innovation	Tacoma	Washington
United States	Meridian Clinical Research, LLC	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Palm Beach Research Center	West Palm Beach	Florida

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 Headache Relief	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
Other	Number of Participants With Headache Recurrence	The number of participants with headache recurrence (moderate or severe at baseline 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
Other	Percentage of Participants Use of Rescue Medication	The percentage of participants who used rescue medication.	2 hours post dose
Other	Percentage of Participants Use of Rescue Medication	The percentage of participants who used rescue medication.	From 2 Hours Post Dose Up to 24 Hours
Other	Percentage of Participants Use of Rescue Medication	The percentage of participants who used rescue medication.	From 24 Post Dose Up to 48 Hours
Other	Percentage of Participants Nausea Free	The percentage of participant without nausea.	2 hours post dose
Other	Percentage of Participants With Phonophobia Free	The percentage of participants without phonophobia.	2 hours post dose
Other	Percentage of Participants With Photophobia Free	The percentage of participants without photophobia.	2 hours post dose
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
Other	Number of Participants With Treatment Emergent Events	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	From Baseline Up to End of Study (Up to 11 Weeks)
Primary	Percentage of Participants Headache Pain Free at 2 Hours Post Dose	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