Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHW | Other Identifier | Eli Lilly and Company | |
| 2019-004379-38 | EudraCT Number | ||
| 2023-506724-85-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Study terminated due to strategic business decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25/50/100 mg Lasmiditan | Experimental |
|
|
| 50/100/200 mg Lasmiditan | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs) | An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | Baseline up to 12-month treatment period (Up to 12 Months) |
| Number of Participants With Discontinuations Due to Adverse Events (AEs) | Participants who discontinued due to adverse events were reported in this outcome measure. | Baseline up to 12-month treatment period (Up to 12 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | 35205 | United States | ||
| Rehabilitation & Neurological Services |
Not provided
| Label | URL |
|---|---|
| A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
A participant who was randomly assigned but did not treat migraine with the study drug was considered to have completed the study if the participant did not discontinue during the 12-month treatment period and attended the End of Study visit, as pre-specified in the protocol.
Participants with migraine who participated in parent studies H8H MC LAHX (NCT03988088) or H8H MC LAHV (NCT04396236) were enrolled into this study H8H MC LAHW (NCT04396574) following completion of those studies, if they met eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 25/50/100 mg Lasmiditan |
|
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2023 | May 27, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) |
| Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief. | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) |
| Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose | Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent. MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack. | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Perseverance Research Center | Scottsdale | Arizona | 85254 | United States |
| Center for Neurosciences | Tucson | Arizona | 85718 | United States |
| Arkansas Children's | Little Rock | Arkansas | 72202 | United States |
| Core Healthcare Group | Cerritos | California | 90703 | United States |
| Miller Children's & Women's Hospital Long Beach | Long Beach | California | 90806 | United States |
| Sensa Health | Los Angeles | California | 90006 | United States |
| Orange County Research Institute - Ontario | Ontario | California | 91762 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06501 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Wolfson Children's Hospital | Jacksonville | Florida | 32207 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| Biotech Pharmaceutical Group | Miami | Florida | 33155 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Ezy Medical Research | Miami Lakes | Florida | 33015 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Avanza Medical Research Center | Pensacola | Florida | 32503 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| USF Health | Tampa | Florida | 33612 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Pediatric Neurology P.A. | Winter Park | Florida | 32789 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Medical Research Partners | Ammon | Idaho | 83406 | United States |
| Velocity Clinical Research, Boise | Meridian | Idaho | 83642 | United States |
| Chicago Headache Center and Research Institute | Chicago | Illinois | 60657 | United States |
| Chicago Headache Center and Research Institute - Naperville | Naperville | Illinois | 60563 | United States |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | United States |
| Fort Wayne Neurological Center - West | Fort Wayne | Indiana | 46804 | United States |
| Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | 46256 | United States |
| Deaconess Clinic - Gateway Health Center | Newburgh | Indiana | 47630 | United States |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | United States |
| Qualmedica Research, LLC | Bowling Green | Kentucky | 42101 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Velocity Clinical Research - New Orleans | New Orleans | Louisiana | 70119 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02154 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Minneapolis Clinic of Neurology - Burnsville Office | Burnsville | Minnesota | 55337 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Accellacare - Piedmont | Statesville | North Carolina | 28625 | United States |
| Accellacare - Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Headache Center of Hope | Cincinnati | Ohio | 45236 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | United States |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| ARC Clinical Research at Four Point | Austin | Texas | 78726 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Pain and Headache Centers of Texas | Houston | Texas | 77054 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| Medical Research Partners - Logan | Logan | Utah | 84341 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| Marshall Medical Center | Huntington | West Virginia | 25701 | United States |
| Frontier Clinical Research | Kingwood | West Virginia | 26537 | United States |
| UZ Brussel | Brussels | 1090 | Belgium |
| Private Practice - Dr. Sava Simona | Saint-Nicolas | 4460 | Belgium |
| Bluewater Clinical Research Group Inc. | Sarnia | N7T 4X3 | Canada |
| CHU d'Amiens-Picardie - Hôpital Sud | Amiens | 80054 | France |
| Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | 63100 | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94010 | France |
| Centre Hospitalier Général de Mont de Marsan - Hôpital Layné | Mont-de-Marsan | 40024 | France |
| Private Practice - Dr. Irma Schöll | Bad Homburg | 61348 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Artemis hospital | Gurgaon | 122003 | India |
| Mangala Hospital & Mangala Kidney Foundation | Mangalore | 575003 | India |
| Getwell Hospital and Research Institute | Nagpur | 440012 | India |
| G.B. Pant Institute of Postgraduate Medical Education & Research | New Delhi | 110002 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Bhakti Vedanta Hospital and Research Institute | Thane | 401107 | India |
| Ospedale San Paolo Bari | Bari | 70123 | Italy |
| IRCCS Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Universita degli Studi della Campania Luigi Vanvitelli | Naples | 80131 | Italy |
| Fondazione Istituto Neurologico C. Mondino | Pavia | 27100 | Italy |
| Ospedale Pediatrico Bambino Gesù | Roma | 00165 | Italy |
| Hiroshima City Hospital | Hiroshima | 730-8518 | Japan |
| Tanaka Neurosurgery&Headache Clinic | Kagoshima | 890-0052 | Japan |
| Nagaseki Headache Clinic | Kai | 400-0124 | Japan |
| Hikita Pediatric clinic | Kiryū | 376-0035 | Japan |
| Konan Hospital | Kobe | 658-0064 | Japan |
| Umenotsuji Clinic | Kochi | 780-8011 | Japan |
| Tatsuoka Neurology Clinic | Kyoto | 600-8811 | Japan |
| Japanese Red Cross Kyoto Daiichi Hospital | Kyoto | 605-0981 | Japan |
| Shinagawa Strings Clinic | Minato | 108-0075 | Japan |
| Nishinomiya Municipal Central Hospital | Nishinomiya | 663-8014 | Japan |
| Yamaguchi Clinic | Nishinomiya | 663-8204 | Japan |
| Hyogo College of Medicine | Nishinomiya | 663-8501 | Japan |
| Tominaga Hospital | Osaka | 556-0017 | Japan |
| Sendai Headache and Neurology Clinic | Sendai | 982-0014 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | 160-0023 | Japan |
| Tokyo Headache Clinic | Tokyo | 151-0051 | Japan |
| Centro de Investigacion Medica Aguascalientes | Aguascalientes | 20116 | Mexico |
| Unidad de Investigación en Salud | Chihuahua City | 31203 | Mexico |
| AGNI Research and Assessment S.C. | Cuernavaca | 1203 | Mexico |
| PanAmerican Clinical Research - Guadalajara | Guadalajara | 44690 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | 66460 | Mexico |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Isala, locatie Zwolle | Zwolle | 8025 AB | Netherlands |
| Dr. Samuel Sanchez PSC | Caguas | 00727 | Puerto Rico |
| Puerto Rico Health Institute | Dorado | 00646 | Puerto Rico |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| Wellness clinical Research Vega Baja | Vega Baja | 00694 | Puerto Rico |
| Prof. Dr. Alexandru Obregia Psychiatry Hospital | Bucharest | 41914 | Romania |
| Spitalul clinic de urgenta pentru copii Sf. Maria | Iași | 700309 | Romania |
| Limited Liability Company University Clinic of headaches | Moscow | 121467 | Russia |
| Sibneyromed Urban Neurological Center | Novosibirsk | 630091 | Russia |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | 8950 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitari Parc Tauli | Sabadell | 8208 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital ClÃnico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Royal Hospital for Sick Children | Glasgow | G51 4TF | United Kingdom |
| James Paget University Hospital | Great Yarmouth | NR31 6LA | United Kingdom |
| Re:Cognition Health - London | London | W1G 9JF | United Kingdom |
| Great Ormond Street Hospital For Children NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
| Queen's Medical Centre, Nottingham University Hospitals | Nottingham | NG7 2UH | United Kingdom |
| Stepping Hill Hospital | Stockport | SK2 7JE | United Kingdom |
| FG001 | 50/100/200 mg Lasmiditan |
|
|
| At Least One Dose of Study Drug |
|
| Evaluable Population by Treated Migraine Attack | Evaluable population by treated migraine attack included all treated migraine attacks (50 mg, 100 mg and 200 mg) among participants who received at least one dose. Each attack was analyzed according to exposure of lasmiditan [50 mg (N=38), 100 mg (N=266), and 200 mg (N=204)], comprising the total (N=508). Participants with protocol-defined dose reduction contributed data to more than one dose-exposure group; therefore, sum across arms (N=508) exceeds number of unique participants (N=470). |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study drug, by randomized treatment regimen, as pre-specified in the Statistical Analysis Plan (SAP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 25/50/100 mg Lasmiditan |
|
| BG001 | 50/100/200 mg Lasmiditan |
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs) | An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug and were analyzed by randomized treatment regimen, as pre-specified in the SAP. | Posted | Count of Participants | Participants | No | Baseline up to 12-month treatment period (Up to 12 Months) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Discontinuations Due to Adverse Events (AEs) | Participants who discontinued due to adverse events were reported in this outcome measure. | All randomized participants who received at least one dose of study drug and were analyzed by randomized treatment regimen, as pre-specified in the SAP. | Posted | Count of Participants | Participants | No | Baseline up to 12-month treatment period (Up to 12 Months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom. | Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation. | Posted | Number | % of treated migraine attacks with PF | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Treated Migraine Attacks | Treated Migraine Attacks |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief. | Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation. | Posted | Number | % of treated migraine attacks with PR | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Treated Migraine Attacks | Treated Migraine Attacks |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose | Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent. MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack. | Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation. | Posted | Number | % of MBS-free treated migraine attacks | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Treated Migraine Attacks | Treated Migraine Attacks |
|
Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25/50/100 mg Lasmiditan |
| 0 | 259 | 6 | 259 | 66 | 259 |
| EG001 | 50/100/200 mg Lasmiditan |
| 0 | 249 | 7 | 249 | 91 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Delirium febrile | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 28.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2020 | May 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C554777 | lasmiditan |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| France |
|
| Germany |
|
| India |
|
| Italy |
|
| Japan |
|
| Mexico |
|
| Netherlands |
|
| Romania |
|
| Russia |
|
| Spain |
|
| United Kingdom |
|
| United States |
|
|
|
Participants who received 50 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
| OG001 | 100 mg Lasmiditan | Participants who received 100 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
| OG002 | 200 mg Lasmiditan | Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
|
|
Participants who received 50 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
| OG001 | 100 mg Lasmiditan | Participants who received 100 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
| OG002 | 200 mg Lasmiditan | Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
|
|
| OG001 | 100 mg Lasmiditan | Participants who received 100 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
| OG002 | 200 mg Lasmiditan | Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm. |
|
|