PIONEER-PEDS2: A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04396574
Collaborator
(none)
1,000
178
2
69
5.6
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Actual Study Start Date
:
Jun 30, 2020
Anticipated Primary Completion Date
:
Mar 31, 2026
Anticipated Study Completion Date
:
Mar 31, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lasmiditan Dose 1 Lasmiditan administered orally. |
Drug: Lasmiditan
Administered orally
Other Names:
|
| Experimental: Lasmiditan Dose 2 Lasmiditan administered orally. |
Drug: Lasmiditan
Administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack [Baseline through 12 Months]
Percentage of TEAEs by Treated Migraine Attack
- Percentage of Participants with Discontinuations Due to Adverse Events (AEs) [Baseline through 12 Months]
Percentage of Participants with Discontinuations Due to AEs
Secondary Outcome Measures
- Percentage of Treated Attacks with Pain Freedom at 2 Hours [12 Months]
Percentage of Treated Attacks with Pain Freedom at 2 Hours
- Percentage of Treated Attacks with Pain Relief at 2 Hours [12 Months]
Percentage of Treated Attacks with Pain Relief at 2 Hours
- Percentage of Treated Attacks with MBS Freedom at 2 Hours [12 Months]
Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
-
Participants must weigh at least 15 kilograms (kg)
Exclusion Criteria:
-
Participants must not be pregnant or nursing
-
Participants must not have any acute, serious, or unstable medical condition
-
Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Research Associates | Birmingham | Alabama | United States | 35205 |
| 2 | Rehabilitation & Neurological Services | Huntsville | Alabama | United States | 35805 |
| 3 | Xenoscience | Phoenix | Arizona | United States | 85004 |
| 4 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 5 | Perseverance Research Center | Scottsdale | Arizona | United States | 85254 |
| 6 | Center for Neurosciences | Tucson | Arizona | United States | 85718 |
| 7 | Arkansas Children's | Little Rock | Arkansas | United States | 72202 |
| 8 | Core Healthcare Group | Cerritos | California | United States | 90703-2751 |
| 9 | Sun Valley Research Center | Imperial | California | United States | 92251 |
| 10 | MemorialCare Health System - Long Beach Medical Center | Long Beach | California | United States | 90806 |
| 11 | Sensa Health | Los Angeles | California | United States | 90006 |
| 12 | Orange County Research Institute - Ontario | Ontario | California | United States | 91762 |
| 13 | Medical Center For Clinical Research | San Diego | California | United States | 92108-5899 |
| 14 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 15 | Colorado Springs Neurological Associates | Colorado Springs | Colorado | United States | 80907 |
| 16 | Yale New Haven Children's Hospital | New Haven | Connecticut | United States | 06511 |
| 17 | New England Institute for Clinical Research | Stamford | Connecticut | United States | 06905 |
| 18 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 19 | Wolfson Children's Hospital | Jacksonville | Florida | United States | 32207 |
| 20 | Clinical Neuroscience Solutions Inc | Jacksonville | Florida | United States | 32256 |
| 21 | Meridien Research | Maitland | Florida | United States | 32751 |
| 22 | Jackson Memorial Hospital | Miami | Florida | United States | 33136 |
| 23 | Biotech Pharmaceutical Group, LLC | Miami | Florida | United States | 33155 |
| 24 | New Horizon Research Center | Miami | Florida | United States | 33165 3338 |
| 25 | Ezy Medical Research | Miami | Florida | United States | 33175 |
| 26 | Suncoast Clinical Research | New Port Richey | Florida | United States | 34652 |
| 27 | Private Practice - Dr. Laszlo J. Mate | North Palm Beach | Florida | United States | 33408 |
| 28 | Sensible Healthcare, LLC | Ocoee | Florida | United States | 34761 |
| 29 | Avanza Medical Research | Pensacola | Florida | United States | 32503 |
| 30 | Clinical Research Center of Florida | Pompano Beach | Florida | United States | 33060 |
| 31 | University of South Florida | Tampa | Florida | United States | 33612 |
| 32 | ForCare Clinical Research | Tampa | Florida | United States | 33613-1244 |
| 33 | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | United States | 33407 |
| 34 | Pediatric Neurology P.A. | Winter Park | Florida | United States | 32789 |
| 35 | Meridian Clinical Research | Savannah | Georgia | United States | 31406 |
| 36 | Hawaii Pacific Neuroscience | Honolulu | Hawaii | United States | 96817 |
| 37 | St. Lukes Regional Medical Center LTD | Meridian | Idaho | United States | 836426351 |
| 38 | Advanced Clinical Research LLC | Meridian | Idaho | United States | 83642 |
| 39 | Chicago Headache Center | Chicago | Illinois | United States | 60657 |
| 40 | Alexian Brothers Medical Center | Hoffman Estates | Illinois | United States | 60169 |
| 41 | Qualmedica Research, LLC | Evansville | Indiana | United States | 47715 |
| 42 | Fort Wayne Neurological Center | Fort Wayne | Indiana | United States | 46804 |
| 43 | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | United States | 46256 |
| 44 | Deaconess Clinic | Newburgh | Indiana | United States | 47630 |
| 45 | Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | United States | 50265 |
| 46 | Alliance for Multispecialty Research, LLC | Wichita | Kansas | United States | 67207 |
| 47 | Qualmedica Research, LLC | Bowling Green | Kentucky | United States | 42101 |
| 48 | University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536 |
| 49 | Qualmedica Research, LLC | Owensboro | Kentucky | United States | 42301 |
| 50 | Children's Hospital of New Orleans LCMC Health | New Orleans | Louisiana | United States | 70118 |
| 51 | Pharmasite Research, Inc. | Baltimore | Maryland | United States | 21208 |
| 52 | ActivMed Practices & Research, Inc. | Lawrence | Massachusetts | United States | 01843 |
| 53 | MedVadis Research Corporation | Waltham | Massachusetts | United States | 02451 |
| 54 | New England Regional Headache Center, Inc | Worcester | Massachusetts | United States | 01605 0160 |
| 55 | Great Lakes Research Group, Inc. | Bay City | Michigan | United States | 48706 |
| 56 | Michigan State University | East Lansing | Michigan | United States | 48824 |
| 57 | Minneapolis Clinic of Neurology | Burnsville | Minnesota | United States | 55337 |
| 58 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 59 | Clinvest Research LLC | Springfield | Missouri | United States | 65807 |
| 60 | Bio Behavioral Health | Toms River | New Jersey | United States | 08755 |
| 61 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
| 62 | University of North Carolina School of Medicine - Children's Hospital - Children's Research Institute | Chapel Hill | North Carolina | United States | 27599 |
| 63 | PMG Research of Piedmont Healthcare | Statesville | North Carolina | United States | 28625 |
| 64 | Acellacare, Us, Inc | Winston-Salem | North Carolina | United States | 27103 |
| 65 | Lillestol Research | Fargo | North Dakota | United States | 58104 |
| 66 | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 67 | Headache Center of Hope | Cincinnati | Ohio | United States | 45236 |
| 68 | IPS Research Company | Oklahoma City | Oklahoma | United States | 73106 |
| 69 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 70 | Velocity Clinical Research, Providence | East Greenwich | Rhode Island | United States | 02818 |
| 71 | Tribe Clinical Research, LLC | Greenville | South Carolina | United States | 29607-4021 |
| 72 | Dell Children's Medical Group | Austin | Texas | United States | 78723 |
| 73 | ARC Clinical Research at Wilson Parke | Austin | Texas | United States | 78726 |
| 74 | ARC Clinical Research William Cannon | Austin | Texas | United States | 78745 |
| 75 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 76 | Houston Neurology Clinical & Diagnostic Consultants | Houston | Texas | United States | 77054 |
| 77 | ClinPoint Trials | Waxahachie | Texas | United States | 75165 |
| 78 | Children's Specialty Group, PPLC | Norfolk | Virginia | United States | 23510 |
| 79 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007-4209 |
| 80 | Core Clinical Research | Everett | Washington | United States | 98201 |
| 81 | Seattle Children's Research Institute | Seattle | Washington | United States | 98105 |
| 82 | Seattle Women's: Health, Research, Gynecology | Seattle | Washington | United States | 98105 |
| 83 | Mary Bridge Children's Neurology | Tacoma | Washington | United States | 98405 |
| 84 | Marshall Medical Center | Huntington | West Virginia | United States | 25701 |
| 85 | Universitair Ziekenhuis Brussel | Jette | Brussels | Belgium | 1090 |
| 86 | Universitair Ziekenhuis Gent | Gent | East Flanders | Belgium | 9000 |
| 87 | Ziekenhuis Oost - Limburg ZOL - Kinderneurologie | Genk | Limburg | Belgium | 3600 |
| 88 | Private Practice - Dr. Sava Simona | Saint-Nicolas | Wallonne, Région | Belgium | 4460 |
| 89 | Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | Puy-de-Dôme | France | 63100 |
| 90 | CHU Amiens - Hopital Sud | Amiens Cedex 1 | France | 80054 | |
| 91 | Centre Hospitalier Intercommunal de Créteil | Creteil | France | 94000 | |
| 92 | CHU Dijonon | Dijon | France | 21000 | |
| 93 | CHRU de Lille | Lille | France | 59037 | |
| 94 | APHM Hôpital de la Timone | Marseille Cedex 5 | France | 13385 | |
| 95 | Centre Hospitalier de Mont de Marsan | Mont-de-Marsan Cedex | France | 40024 | |
| 96 | Hôpital Armand Trousseau | Paris | France | 75012 | |
| 97 | Hôpital de HautePierre | Strasbourg | France | 67 098 | |
| 98 | CHU de Toulouse - Hôpital des Enfants | Toulouse Cedex 9 | France | 31026 | |
| 99 | Universitaetsklinikum Freiburg | Freiburg | Baden-Württemberg | Germany | 79106 |
| 100 | Klinikum Sindelfingen-Böblingen | Sindelfingen | Baden-Württemberg | Germany | 71065 |
| 101 | Zentrum für klinische Forschung | Bad Homburg | Hesse | Germany | 61348 |
| 102 | Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie | Essen | Nordrhein-Westfalen | Germany | 45133 |
| 103 | St Josef-Hospital Bochum | Bochum | North Rhine-Westphalia | Germany | 44791 |
| 104 | G.B. Pant Institute of Postgraduate Medical Education & Research | New Delhi | Delhi | India | 110002 |
| 105 | All India Institute of Medical Sciences | New Delhi | Delhi | India | 110029 |
| 106 | Sir Ganga Ram Hospital | New Delhi | Delhi | India | 110060 |
| 107 | Panchshil hospital | Ahmedabad | Gujarat | India | 380005 |
| 108 | Artemis Hospital | Gurgaon | Haryana | India | 122001 |
| 109 | Mangala Hospital & Mangala Kidney Foundation | Mangalore | Karnataka | India | 575003 |
| 110 | P.D. Hinduja Hospital and Medical Research Centre | Mumbai | Maharashtra | India | 400016 |
| 111 | Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | India | 411004 |
| 112 | Bhaktivedanta Hospital and Research Institute | Thane | Maharashtra | India | 401107 |
| 113 | Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur | Rajasthan | India | 302004 |
| 114 | Cliniton Multi-Speciality Clinic | Jaipur | Rajasthan | India | 302017 |
| 115 | Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | India | 700054 |
| 116 | Postgraduate Institute of Medical Education & Research | Chandigarh | India | 160012 | |
| 117 | UOSD di Neuropsichiatria Infantile | Napoli | Naples | Italy | 80131 |
| 118 | Azienda Ospedaliero Universitaria Meyer | Florence | Italy | 50139 | |
| 119 | Istituto Neurologico Carlo Besta | Milano | Italy | 20133 | |
| 120 | Fondazione Istituto Neurologico C. Mondino | Pavia | Italy | 27100 | |
| 121 | Ospedale Bambino Gesu | Roma | Italy | 00165 | |
| 122 | Ospedale Filippo del Ponte | Varese | Italy | 21017 | |
| 123 | Hikita Pediatric clinic | Kiryu | Gunma | Japan | 3760035 |
| 124 | Konan Hospital | Kobe | Hyogo | Japan | 658-0064 |
| 125 | Nishinomiya Municipal Central Hospital | Nishinomiya | Hyogo | Japan | 663-8014 |
| 126 | Yamaguchi Clinic | Nishinomiya | Hyogo | Japan | 663-8204 |
| 127 | Hyogo College of Medicine | Nishinomiya | Hyogo | Japan | 663-8501 |
| 128 | Japanese Red Cross Kyoto Daiichi Hospital | Higashiyamaku | Kyoto | Japan | 605-0981 |
| 129 | Sendai Headache and Neurology Clinic | Sendai | Miyagi | Japan | 982-0014 |
| 130 | Shinagawa Strings Clinic | Minato-ku | Tokyo | Japan | 108-0075 |
| 131 | Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | Japan | 160-0023 |
| 132 | Nagaseki Headache Clinic | Kai | Yamanashi | Japan | 400-0124 |
| 133 | Hiroshima City Hospital | Hiroshima | Japan | 730-8518 | |
| 134 | Tanaka Neurosurgical Clinic | Kagoshima | Japan | 892-0844 | |
| 135 | Umenotsuji Clinic | Kochi | Japan | 780-8011 | |
| 136 | Tatsuoka Neurology Clinic | Kyoto | Japan | 600-8811 | |
| 137 | Tominaga Hospital | Osaka | Japan | 556-0017 | |
| 138 | Tokyo Headache Clinic | Tokyo | Japan | 151-0051 | |
| 139 | Hospital Infantil de Mexico Federico Gomez | Ciudad de Mexico | Federal District | Mexico | 06720 |
| 140 | Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | Mexico | 44280 |
| 141 | PanAmerican Clinical Research S.A.de C.V. Guadalajara | Guadalajara | JA | Mexico | 44670 |
| 142 | AGNI Research and Assessment S.C. | Cuernavaca | Morelos | Mexico | |
| 143 | Hospital Universitario UANL | Monterrey | Nuevo Leon | Mexico | 64460 |
| 144 | Centro de Investigacion Medica Aguascalientes | Aguascalientes | Mexico | 20116 | |
| 145 | Unidad de Investigación en Salud | Chihuahua | Mexico | 31203 | |
| 146 | Isala, locatie Zwolle | Zwolle | Overijssel | Netherlands | 8025 AB |
| 147 | Canisius-Wilhelmina Ziekenhuis | Nijmegen | Netherlands | 6532 SZ | |
| 148 | Dr. Samuel Sanchez PSC | Caguas | Puerto Rico | 00727 | |
| 149 | Puerto Rico Health Institute | Dorado | Puerto Rico | 00646 | |
| 150 | Ponce School of Medicine CAIMED Center | Ponce | Puerto Rico | 00716 | |
| 151 | Wellness clinical Research Vega Baja | Vega Baja | Puerto Rico | 00694 | |
| 152 | Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia" | Bucuresti | Sector 4 | Romania | 041914 |
| 153 | Spitalul Clinic de Urgenta pentru Copii Brasov | Brasov | Romania | 500063 | |
| 154 | SC Delta Health Care SRL | Bucuresti | Romania | 014142 | |
| 155 | Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta | Constanta | Romania | 900591 | |
| 156 | Spitalul clinic de urgenta pentru copii Sf. Maria | Iasi | Romania | 700309 | |
| 157 | Limited Liability Company University Clinic of headaches | Moscow | Moskva | Russian Federation | 121467 |
| 158 | Pirogov Russian National Research Medical University | Moscow | Russian Federation | 117513 | |
| 159 | Clinic Chaika | Moscow | Russian Federation | 123317 | |
| 160 | Sibneyromed Urban Neurological Center | Novosibirsk | Russian Federation | 630091 | |
| 161 | "Medical Technologies" Ltd | Saint-Petersburg | Russian Federation | 191025 | |
| 162 | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | Spain | 8035 |
| 163 | Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] | Spain | 8950 |
| 164 | Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona | Spain | 08208 |
| 165 | Hospital Clinico Universitario de Valladolid | Valladolid | Castilla Y Leon | Spain | 47005 |
| 166 | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 167 | Hospital de la Santa Creu I Sant Pau - NEURO | Barcelona | Spain | 08025 | |
| 168 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 169 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 170 | Hospital Universitario Virgen Del Rocio | Sevilla | Spain | 41013 | |
| 171 | Hospital Clínico Universitario de Valencia | Valencia | Spain | 46010 | |
| 172 | University Hospital Lewisham | London | Greater London | United Kingdom | SE13 6LH |
| 173 | Re:Cognition Health | London | Greater London | United Kingdom | W1G 9JF |
| 174 | Great Ormond Street Hospital For Children NHS Foundation Trust | Bloomsbury | London | United Kingdom | WC1N 3JH |
| 175 | The James Paget Hospital | Great Yarmouth | Norfolk | United Kingdom | NR31 6LA |
| 176 | The Sackler Clinical Research Facility | Glasgow | United Kingdom | GF51 4TF | |
| 177 | Queen's Medical Centre, Nottingham University Hospitals | Nottingham | United Kingdom | NG7 2UH | |
| 178 | Stepping Hill Hospital | Stockport | United Kingdom | SK2 7JE |
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, Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04396574
Other Study ID Numbers:
- 16930
- H8H-MC-LAHW
- 2019-004379-38
First Posted:
May 20, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 15, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: