A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Phase 1

• Conditions: Migraine; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-001661-17-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-19
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1471

Inclusion Criteria

- Are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age at time of screening with migraine with or without aura fulfilling the IHS (International Headache Society) diagnostic criteria 1.1 or 1.2.
- History of disabling migraine for at least 1 year.
- Migraine onset before the age of 50 years.
- History of 3 to 8 migraine attacks per month (< 15 headache days per month).
- MIDAS score =11.
- Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug.
- Women of child-bearing potential must be using or willing to use a highly effective form of contraception until 30 days after the last dose.
- Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed.
- Are able and willing to give signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

-Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
-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, Meniere’s disease, vestibular migraine, and other vestibular disorders
-History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
-History of orthostatic hypotension with syncope
-Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
-Patients who, in the investigator’s judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
-History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is =15 headache days per month
- Use of more than 3 doses per month of either opioids or barbiturates
- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to Screening
-Pregnant or breast-feeding women
- History of drug or alcohol abuse/dependence within 1 year prior to screening
-Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study.
· Currently enrolled in any other clinical study involving an investigational product
-Relatives of, or staff directly reporting to, the Investigator.
-Participants who are employees of the sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo.<br>- To evaluate the consistency of response to lasmiditan 200 mg and 100 mg compared to placebo.;Secondary Objective: -To evaluate the efficacy of lasmiditan 200 mg and 100 mg on freedom<br>from MBS compared to placebo.<br>- To evaluate the efficacy of lasmiditan 200 mg and 100 mg on pain relief<br>compared to placebo.;Primary end point(s): 1. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none).<br>2. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none).;Timepoint(s) of evaluation of this end point: 1: at 2 hours postdose during the first attack.<br>2: at 2 hours postdose in at least 2 out of 3 attacks.