Migraine Clinical Trial
— PIONEER-PEDS1Official title:
Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
| Status | Recruiting |
| Enrollment | 1633 |
| Est. completion date | January 31, 2025 |
| Est. primary completion date | January 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Participants must have 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 - Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator - Participant must be able to swallow a tablet - For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Brussel | Brussels | Bruxelles-Capitale, Région De |
| Belgium | UZ Gent | Gent | Oost-Vlaanderen |
| France | CHU d'Amiens-Picardie - Hôpital Sud | Amiens | Somme |
| France | Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | Puy-de-Dôme |
| France | Centre Hospitalier Intercommunal de Créteil | Créteil | Val-de-Marne |
| France | Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro | Lille | Nord-Pas-de-Calais |
| France | Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone | Marseille | Bouches-du-Rhône |
| France | Centre Hospitalier Général de Mont de Marsan - Hôpital Layné | Mont-de-Marsan | Landes |
| France | Hôpital Armand Trousseau | Paris | |
| France | CHU Strasbourg-Hautepierre | Strasbourg | Bas-Rhin |
| France | Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan | Toulouse | Haute-Garonne |
| Germany | Private Practice - Dr. Irma Schöll | Bad Homburg | Hessen |
| Germany | Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital | Bochum | Nordrhein-Westfalen |
| Germany | Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Sp -T | Essen | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Freiburg | Freiburg | Baden-Württemberg |
| India | Panchshil hospital | Ahmedabad | Gujarat |
| India | Artemis hospital | Gurugram | Haryana |
| India | Mangala Hospital & Mangala Kidney Foundation | Mangalore | Karnataka |
| India | Lillestol Research | Nagpur | Maharashtra |
| India | All India Institute of Medical Sciences | New Delhi | Delhi |
| India | G.B. Pant Institute of Postgraduate Medical Education & Research | New Delhi | Delhi |
| India | Sir Ganga Ram Hospital | New Delhi | Delhi |
| India | Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra |
| India | Bhakti Vedanta Hospital and Research Institute | Thane | Maharashtra |
| Italy | Ospedale San Paolo Bari | Bari | Puglia |
| Italy | A.O.Universitaria Meyer | Firenze | Toscana |
| Italy | Universita degli Studi della Campania Luigi Vanvitelli | Napoli | Campania |
| Italy | Fondazione Istituto Neurologico C. Mondino | Pavia | |
| Italy | Ospedale Pediatrico Bambino Gesù | Roma | |
| Italy | Ospedale Filippo del Ponte Varese | Varese | |
| Japan | Hiroshima City Hospital | Hiroshima | |
| Japan | Tanaka Neurosurgical Clinic | Kagoshima | |
| Japan | Nagaseki Headache Clinic | Kai | Yamanashi |
| Japan | Kanagawa cancer center | Kiryu | Gunma |
| Japan | Konan Hospital | Kobe | Hyogo |
| Japan | Umenotsuji Clinic | Kochi | |
| Japan | Japanese Red Cross Kyoto Daiichi Hospital | Kyoto | |
| Japan | Tatsuoka Neurology Clinic | Kyoto | |
| Japan | Shinagawa Strings Clinic | Minato | Tokyo |
| Japan | Hyogo College of Medicine | Nishinomiya | Hyogo |
| Japan | Nishinomiya Municipal Central Hospital | Nishinomiya | Hyogo |
| Japan | Yamaguchi Clinic | Nishinomiya | Hyogo |
| Japan | Tominaga Hospital | Osaka | |
| Japan | Sendai Headache and Neurology Clinic | Sendai | Miyagi |
| Japan | Tokyo Medical University Hospital | Shinjuku-ku | Tokyo |
| Japan | Tokyo Headache Clinic | Tokyo | |
| Mexico | Centro de Investigacion Medica Aguascalientes | Aguascalientes | |
| Mexico | Unidad de Investigación en Salud | Chihuahua | |
| Mexico | AGNI Research and Assessment S.C. | Cuernavaca | Morelos |
| Mexico | Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco |
| Mexico | PanAmerican Clinical Research - Guadalajara | Guadalajara | Jalisco |
| Mexico | Hospital Infantil de Mexico Federico Gomez | Mexico City | Distrito Federal |
| Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León |
| Netherlands | Canisius-Wilhelmina Ziekenhuis | Nijmegen | Gelderland |
| Netherlands | Isala, locatie Zwolle | Zwolle | Overijssel |
| Puerto Rico | Dr. Samuel Sanchez PSC | Caguas | |
| Puerto Rico | Puerto Rico Health Institute | Dorado | |
| Puerto Rico | Ponce Medical School Foundation Inc. | Ponce | |
| Puerto Rico | Wellness clinical Research Vega Baja | Vega Baja | |
| Romania | Spitalul Clinic de Copii Bra?ov | Bra?ov | |
| Romania | Delta Health Care | Bucharest | Bucure?ti |
| Romania | Prof. Dr. Alexandru Obregia Psychiatry Hospital | Bucharest | Bucure?ti |
| Romania | Constanta County Emergency Clinical Hospital Sf.Ap.Andrei | Constanta | |
| Romania | Spitalul clinic de urgenta pentru copii Sf. Maria | Iasi | |
| Russian Federation | First Moscow State Medical University I.M. Sechenov | Moscow | |
| Russian Federation | Limited Liability Company University Clinic of headaches | Moscow | Moskva |
| Russian Federation | Saint-Petersburg State Pediatric Medical University | Saint Petersburg | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona [Barcelona] |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] |
| Spain | Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcon | Madrid |
| Spain | Hospital Universitari Parc Tauli | Sabadell | Barcelona [Barcelona] |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Hospital Clinico de Valencia | Valencia | Valenciana, Comunitat |
| Spain | Hospital Clínico Universitario de Valladolid | Valladolid | |
| United Kingdom | Great Ormond Street Hospital For Children NHS Foundation Trust | Bloomsbury | London |
| United Kingdom | Royal Hospital for Sick Children | Glagow | Scotland |
| United Kingdom | James Paget University Hospital | Great Yarmouth | Norfolk |
| United Kingdom | Re:Cognition Health - London | London | London, City Of |
| United Kingdom | University Hospital Lewisham | London | London, City Of |
| United States | Medical Research Partners | Ammon | Idaho |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | ARC Clinical Research at Wilson Parke | Austin | Texas |
| United States | Pharmasite Research, Inc. | Baltimore | Maryland |
| United States | Great Lakes Research Group, Inc. | Bay City | Michigan |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Central Research Associates | Birmingham | Alabama |
| United States | Qualmedica Research, LLC | Bowling Green | Kentucky |
| United States | Minneapolis Clinic of Neurology - Burnsville Office | Burnsville | Minnesota |
| United States | Core Healthcare Group | Cerritos | California |
| United States | Chicago Headache Center and Research Institute | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Headache Center of Hope | Cincinnati | Ohio |
| United States | Colorado Springs Neurological Associates | Colorado Springs | Colorado |
| United States | Driscoll Children's Hospital | Corpus Christi | Texas |
| United States | Velocity Clinical Research, Providence | East Greenwich | Rhode Island |
| United States | Michigan State University | East Lansing | Michigan |
| United States | Qualmedica Research, LLC | Evansville | Indiana |
| United States | Core Clinical Research | Everett | Washington |
| United States | Pine Street Pediatrics | Exeter | California |
| United States | Fort Wayne Neurological Center - West | Fort Wayne | Indiana |
| United States | Tribe Clinical Research, LLC | Greenville | South Carolina |
| United States | St. Alexius Medical Center | Hoffman Estates | Illinois |
| United States | Hawaii Pacific Neuroscience | Honolulu | Hawaii |
| United States | Pain and Headache Centers of Texas | Houston | Texas |
| United States | Marshall Medical Center | Huntington | West Virginia |
| United States | Rehabilitation & Neurological Services | Huntsville | Alabama |
| United States | Sun Valley Research Center | Imperial | California |
| United States | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana |
| United States | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida |
| United States | Wolfson Children's Hospital | Jacksonville | Florida |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | Frontier Clinical Research | Kingwood | West Virginia |
| United States | Alliance for Multispecialty Research, LLC | Layton | Utah |
| United States | University of Kentucky Chandler Medical Center | Lexington | Kentucky |
| United States | Arkansas Children's | Little Rock | Arkansas |
| United States | Miller Children's & Women's Hospital Long Beach | Long Beach | California |
| United States | Sensa Health | Los Angeles | California |
| United States | St Luke's Meridian Medical Center | Meridian | Idaho |
| United States | Velocity Clinical Research, Boise | Meridian | Idaho |
| United States | ActivMed Practices and Research | Methuen | Massachusetts |
| United States | Biotech Pharmaceutical Group | Miami | Florida |
| United States | Ezy Medical Research | Miami | Florida |
| United States | New Horizon Research Center | Miami | Florida |
| United States | University of Miami Don Suffer Clinical Research Building | Miami | Florida |
| United States | Monroe Biomedical Research | Monroe | North Carolina |
| United States | Chicago Headache Center and Research Institute - Naperville | Naperville | Illinois |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Children's Hospital New Orleans | New Orleans | Louisiana |
| United States | Velocity Clinical Research - New Orleans | New Orleans | Louisiana |
| United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
| United States | Deaconess Clinic - Gateway Health Center | Newburgh | Indiana |
| United States | Sensible Healthcare, LLC | Ocoee | Florida |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Orange County Research Institute - Ontario | Ontario | California |
| United States | Qualmedica Research, LLC | Owensboro | Kentucky |
| United States | Avanza Medical Research Center | Pensacola | Florida |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Xenoscience | Phoenix | Arizona |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Medical Research Partners - Providence | Providence | Utah |
| United States | SKY Clinical Research Network Group | Ridgeland | Mississippi |
| United States | Medical Center for Clinical Research | San Diego | California |
| United States | Meridian Clinical Research, LLC | Savannah | Georgia |
| United States | Frontier Clinical Research, LLC | Scottdale | Pennsylvania |
| United States | Perseverance Research Center | Scottsdale | Arizona |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | Seattle Clinical Research Center | Seattle | Washington |
| United States | Frontier Clinical Research, LLC | Smithfield | Pennsylvania |
| United States | Clinvest Research LLC | Springfield | Missouri |
| United States | Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford | Connecticut |
| United States | Accellacare - Piedmont | Statesville | North Carolina |
| United States | MultiCare Health System | Tacoma | Washington |
| United States | ForCare Clinical Research | Tampa | Florida |
| United States | USF Health | Tampa | Florida |
| United States | Center for Neurosciences | Tucson | Arizona |
| United States | Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia |
| United States | MedVadis Research Corporation | Waltham | Massachusetts |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | ClinPoint Trials | Waxahachie | Texas |
| United States | Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa |
| United States | Palm Beach Neurology | West Palm Beach | Florida |
| United States | Alliance for Multispecialty Research, LLC | Wichita | Kansas |
| United States | Pediatric Neurology P.A. | Winter Park | Florida |
| United States | New England Regional headache Center, Inc | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Belgium, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Romania, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Pain Freedom (High Dose) | Percentage of Participants with Pain Freedom (High Dose) | 2 Hours Postdose | |
| Secondary | Percentage of Participants with Pain Freedom (Mid Dose) | Percentage of Participants with Pain Freedom (Mid Dose) | 2 Hours Postdose | |
| Secondary | Percentage of Participants with Pain Freedom (Low Dose) | Percentage of Participants with Pain Freedom (Low Dose) | 2 Hours Postdose | |
| Secondary | Percentage of Participants with Pain Freedom (Age Sub-Groups) | Percentage of Participants with Pain Freedom (Age Sub-Groups) | 2 Hours Postdose | |
| Secondary | Percentage of Participants with Pain Relief | Percentage of Participants with Pain Relief | 2 Hours Postdose | |
| Secondary | Percentage of Participants Most Bothersome Symptom (MBS)-Free | Percentage of Participants MBS-Free | 2 Hours Postdose | |
| Secondary | Percentage of Participants Nausea-Free | Percentage of Participants Nausea-Free | 2 Hours Postdose | |
| Secondary | Percentage of Participants Photophobia-Free | Percentage of Participants Photophobia-Free | 2 Hours Postdose | |
| Secondary | Percentage of Participants Phonophobia-Free | Percentage of Participants Phonophobia-Free | 2 Hours Postdose | |
| Secondary | Percentage of Participants with Sustained Pain Freedom | Percentage of Participants with Sustained Pain Freedom | 24 Hours Postdose | |
| Secondary | Percentage of Participants with Sustained Pain Freedom | Percentage of Participants with Sustained Pain Freedom | 48 Hours Postdose | |
| Secondary | Percentage of Participants Using Additional Medication for Migraine | Percentage of Participants Using Additional Medication for Migraine | 24 Hours Postdose | |
| Secondary | Percentage of Participants Using Additional Medication for Migraine | Percentage of Participants Using Additional Medication for Migraine | 48 Hours Postdose | |
| Secondary | Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely") | Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely") | 2 Hours Postdose | |
| Secondary | Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard" | Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard" | 24 Hours Postdose |
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