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A Study of Lasmiditan in Participants With Migraine

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ClinicalTrials.gov Identifier: NCT03247790
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Lasmiditan Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Multi-center, open-label study with 2 study periods.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Two-Period Study to Evaluate the Pharmacokinetics of Lasmiditan in Migraineurs During Acute Migraine Attacks and During Inter-Ictal Periods
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lasmiditan (Period 1)
Lasmiditan given once orally during migraine attack.
Drug: Lasmiditan
Administered orally
Other Name: LY573144
Experimental: Lasmiditan (Period 2)
Lasmiditan given once orally during inter-ictal period.
Drug: Lasmiditan
Administered orally
Other Name: LY573144


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period [ Time Frame: Baseline through 4 days after administration of study drug ]
    PK: Cmax of Lasmiditan in Each Period

  2. PK: Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period [ Time Frame: Baseline through 4 days after administration of study drug ]
    PK: AUC(0-∞) of Lasmiditan in Each Period


Secondary Outcome Measures :
  1. PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites in Each Period [ Time Frame: Baseline through 4 days after administration of study drug ]
    PK: Cmax of Major Lasmiditan Metabolites in Each Period

  2. PK: Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites in Each Period [ Time Frame: Baseline through 4 days after administration of study drug ]
    PK: AUC(0-∞) of Major Lasmiditan Metabolites in Each Period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247790


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
United States, California
eStudySite Recruiting
San Diego, California, United States, 92120
Contact    619-255-5903      
Principal Investigator: Jeffrey S Overcash, MD         
United States, Florida
AGA Clinical Trials Recruiting
Hialeah, Florida, United States, 33012
Contact    305-819-1551      
Principal Investigator: Dario Altamirano         
Meridien Research Inc. Recruiting
Tampa, Florida, United States, 33634
Contact    813-877-8839      
Principal Investigator: Cynthia Huffman, MD         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03247790     History of Changes
Other Study ID Numbers: 16854
H8H-MC-LAHC ( Other Identifier: Eli Lilly and Company )
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases