A Study of Lasmiditan in Participants With Migraine

Phase 1

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Lasmiditan

• Registration Number: NCT03247790
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks.

Information about any side effects that may occur will also be collected.

This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening).

Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Study Start: 2017-08-16
• Status Verified: 2018-01
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Results First Submitted: 2019-11-08
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-12-02
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
• Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

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Exclusion Criteria

• Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
• Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
• Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or >95 mmHg
• Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
• Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
• Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
• Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lasmiditan (Period 1)	Lasmiditan	200 mg Lasmiditan tablet given once orally during migraine attack.
Lasmiditan (Period 2)	Lasmiditan	200 mg Lasmiditan tablet given once orally during inter-ictal period.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose	PK: Cmax of Lasmiditan in Each Period.
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose	PK: AUC(0-∞) of Lasmiditan in Each Period.

Secondary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose	PK: AUC(0-∞) of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose	PK: Cmax of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.

Trial Locations

Locations (3)

eStudySite; 🇺🇸 San Diego, California, United States

AGA Clinical Trials; 🇺🇸 Hialeah, Florida, United States

Meridien Research Inc.; 🇺🇸 Tampa, Florida, United States