Headache
Conditions
Interventions
This study involves a comparison of lasmiditan film-coated tablets with
placebo. The study medication will be administered by mouth. To maintain the
blind, each dose will require 3 tablets. The prop
Sponsors
Eli Lilly
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Type of Patient and Disease Characteristics [1] Patient is at least 6 and less than 18 years of age at Screening (Visit 1). [2] Patient must have a minimum body weight of 15 kg. [3] Patient has a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: - History of migraine attacks for more than 6 months - Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to Screening Visit - Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to*3 hours - Patient has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator. [4] Patient must be able to swallow a tablet. [5] For patients taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1. Informed Consent and Patient Agreements [6] The patient and patient*s parent or guardian must understand the nature of the study. The patient*s parent or guardian must sign an ICF, and the patient must sign an informed assent document as required by local regulations. [7] The patient and patient*s parent or guardian are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. [8] Patient is male or female; if female, must agree to abide by the following guidance: - Females of childbearing potential (started menses, to include any duration or amount of spotting) must agree to use a highly effective method of contraception (that is, one with less than 1% failure rate) such as o combination oral contraceptives o implanted/injected contraceptives o intrauterine devices, or o sterile partner until 30 days after the last dose of study medication. - Females of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, and postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception. [9] The patient and patient*s parent or guardian must agree not to post any personal medical data related to the study or information related to the study on any website or social media site until notification that the study has been completed. Examples of these sites include - Facebook - Twitter - Snapchat - Instagram, and - Google+.
Exclusion criteria
Exclusion criteria: Medical Conditions [10] Patient has a history or clinical evidence of congenital heart disease, suspected or confirmed. [11] ECG showing abnormalities compatible with acute cardiovascular events, serious cardiovascular disease risk, or both. [12] Within 6 months of screening, patient had - myocardial infarction - unstable angina - percutaneous coronary intervention, and - coronary artery bypass graft. [13] Patient has planned cardiovascular surgery or percutaneous coronary angioplasty, or has a history of stroke. [14] Patient has any liver tests outside the normal range at screening that are clinically significant. Alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or total bilirubin level (TBL) greater than 1.5x ULN, or alkaline phosphatase (ALP) greater than 2x ULN must be discussed and judged not clinically significant by Lilly Medical prior to enrollment. NOTE: Patients with TBL at least 1.5x ULN are not excluded if they meet all of the following criteria for Gilbert syndrome: *- Bilirubin is predominantly indirect (unconjugated) at Screening (direct bilirubin within normal limits) * - Absence of liver disease * - ALT, aspartate aminotransferase (AST), and ALP no greater than 1x ULN at screening, and * Hemoglobin not significantly decreased at screening. [15] Patient has, in the judgement of the investigator, a psychiatric disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, that would interfere with adherence to study requirements or safe participation in the trial. This includes a current or historical diagnosis of a substance use disorder. [16] Patient is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. [17] At Screening: - patient has answered *yes* to either Question 4 or Question 5 on the *Suicidal Ideation* portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or has answered *yes* to any of the suicide-related behaviors on the *suicidal behavior* portion of the C-SSRS, and - the ideation or behavior occurred within the past month. [18] Patient is pregnant or breastfeeding. [19] Patient has, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. Prior and Concomitant Therapy/Substances of Abuse [20] Patient has used opioids or barbiturate-containing analgesic more than 3 times per month for the treatment of pain in more than 2 of the past 6 months. [21] Patient has known allergies to lasmiditan, related compounds, or any components of the formulation. [22] Patient has a positive urine drug screen for any substances of abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary - Proportion of patients >=6 to | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary - Proportion of patients >=6 to =6 to =6 to =6 to =6 to =6 to =6 to =6 to =6 to =6 to =6 to =6 to | — |
Countries
Netherlands
Outcome results
None listed