Acute Treatment of Migraine Clinical Trial
Official title:
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | May 5, 2027 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility | Inclusion Criteria: 1. History of migraine (with or without aura) for = 6 months before Screening 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment. 3. 1 or more migraine days requiring treatment during the Observation Phase. 4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit 5. Ability to distinguish between migraine and other types of headaches. 6. Weight = 40 kg at the Screening Visit. 7. Adequate venous access for blood sampling. 8. Male and female participants = 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study) Exclusion Criteria: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome 3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded). 4. History of suicidal behavior or major psychiatric disorder. 5. Current diagnosis or history of substance abuse; positive drug test at Screening. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci | Karkow | |
| Poland | NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski | Katowice | |
| Poland | NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski | Katowice | |
| Poland | Centrum Medyczne Plejady | Krakow | |
| Poland | Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci | Krakow | |
| Poland | Centrum Medyczne Plejady | Kraków | |
| Poland | Clinical Research Center Sp. z o.o. | Poznan | |
| Poland | Clinical Research Center Spólka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k | Poznan | |
| Poland | Euromedis Sp. z o.o. Osrodek B | Szczecin, | |
| Poland | Centrum Medyczne Oporow | Wroclaw | |
| Poland | Pracownia Badan Klinicznych SALUS | Wroclaw | |
| Spain | Centre Atencio Primaria (CAP) Balenya | Balenya | Barcelona |
| Spain | CAP Balenyà | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitari Vall dHebron | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Instituto de Investigaciones del Sueno | Madrid | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitario Virgen del Rocio (HUVR) | Sevilla | |
| Spain | Hospital Clinico Universitario de Valladolid | Valladolid | |
| United States | Dent Neurosciences Research Center | Amherst | New York |
| United States | Advanced Research Center, Inc. | Anaheim | California |
| United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Atlanta | Georgia |
| United States | Rare Disease Research LLC | Atlanta | Georgia |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | Children's Hospital Colorado Investigational Drug Services | Aurora | Colorado |
| United States | Children's Hospital Colorado- Investigational Drug Services | Aurora | Colorado |
| United States | Child Neurology Consultants of Austin - Central Austin | Austin | Texas |
| United States | Child Neurology Consultants of Austin - South Austin | Austin | Texas |
| United States | Dell Children's Medical Center | Austin | Texas |
| United States | Velocity Clinical Research- Banning | Banning | California |
| United States | Houston Clinical Trials, LLC | Bellaire | Texas |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Boston Clinical Trials | Boston | Massachusetts |
| United States | Pivotal Clinical Research & Associates, LLC | Brunswick | Georgia |
| United States | Physicians Research Group | Chandler | Arizona |
| United States | Chicago Headache Center & Research Institute | Chicago | Illinois |
| United States | Chicago Headache Center & Research Institute | Chicago | Illinois |
| United States | The Neuron Clinic | Chula Vista | California |
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| United States | Drug Delivery-Cincinnati Children's IDS Denise Lagory | Cincinnati | Ohio |
| United States | Velocity Clinical Research - Cincinnati | Cincinnati | Ohio |
| United States | WellNow Urgent Care and Research | Cincinnati | Ohio |
| United States | Novaceut Clinical Research | Clarksville | Tennessee |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Colorado Springs Neurological Associates | Colorado Springs | Colorado |
| United States | Wellnow Urgent Care and Research | Columbus | Ohio |
| United States | Wellnow Urgent Care and Research | Columbus | Ohio |
| United States | CT Clinical Research | Cromwell | Connecticut |
| United States | ProScience Research Group | Culver City | California |
| United States | Cedar Health Research | Dallas | Texas |
| United States | Wellnow Urgent Care and Research | Dayton | Ohio |
| United States | CenExel iResearch, LLC | Decatur | Georgia |
| United States | Velocity Clinical Research-Providence | East Greenwich | Rhode Island |
| United States | ANRC Research | El Paso | Texas |
| United States | Eastside Therapeutic Resource, Inc. dba Core Clinical Research | Everett | Washington |
| United States | Neuro-Pain Medical Center | Fresno | California |
| United States | North Texas Institute of Neurology and Headache | Frisco | Texas |
| United States | North Texas Institute of Neurology and Headache | Frisco | Texas |
| United States | Sarkis Clinical Trials | Gainesville | Florida |
| United States | Boeson Research - Grand Junction, CO | Grand Junction | Colorado |
| United States | Boeson Research GJT | Grand Junction | Colorado |
| United States | Boeson Research GJT | Grand Junction | Colorado |
| United States | Dinosaur Pediatrics | Grand Junction | Colorado |
| United States | Dinosaur Pediatrics | Grand Junction | Colorado |
| United States | Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group | Grand Rapids | Michigan |
| United States | Corewell Health, Helen DeVos Children's Hospital | Grand Rapids | Michigan |
| United States | Outpatient Pediatric Neurology Clinic | Grand Rapids | Michigan |
| United States | Velocity Clinical Research, Grants Pass | Grants Pass | Oregon |
| United States | Boeson Research | Great Falls | Montana |
| United States | Northwest Physicians | Great Falls | Montana |
| United States | Headache Wellness Center | Greensboro | North Carolina |
| United States | Headache Wellness Center, PC | Greensboro | North Carolina |
| United States | Tribe Clinical Research LLC | Greenville | South Carolina |
| United States | Velocity Clinical Research- Greenville | Greenville | South Carolina |
| United States | Premier Neurology | Greer | South Carolina |
| United States | Connecticut Children's Medical Center | Hartford | Connecticut |
| United States | Boeson Research (HLN) | Helena | Montana |
| United States | Houston Clinical Research,LLC. | Houston | Texas |
| United States | Pain and Headache Centers of Texas | Houston | Texas |
| United States | SCLA Management | Houston | Texas |
| United States | Trio Clinical Trials, LLC. | Houston | Texas |
| United States | Children's Clinical Research Center at Riley Hospital for Children at IU Health | Indianapolis | Indiana |
| United States | Riley Hospital for Children at IU Health | Indianapolis | Indiana |
| United States | Wellnow Urgent Care and Research | Kalamazoo | Michigan |
| United States | Boeson Research,LLC | Kalispell | Montana |
| United States | Sunwise Clinical Research | Lafayette | California |
| United States | Multi-Specialty Research Associates, Inc. | Lake City | Florida |
| United States | University of Kentucky Hospital | Lexington | Kentucky |
| United States | Alivation Research, LLC | Lincoln | Nebraska |
| United States | Miller Children's & Women's Hospital Long Beach | Long Beach | California |
| United States | Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy | Los Angeles | California |
| United States | Children's Hospital Los Angeles, Division of Neurology | Los Angeles | California |
| United States | National Research Institute | Los Angeles | California |
| United States | University Hospital | Madison | Wisconsin |
| United States | University of Wisconsin-Madison | Madison | Wisconsin |
| United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
| United States | Le Bonheur Childrens Hospital - Childrens Foundation Research Institute | Memphis | Tennessee |
| United States | Le Bonheur Childrens Hospital - Outpatient Building | Memphis | Tennessee |
| United States | AppleMed Research Group, LLC | Miami | Florida |
| United States | Brainstorm Research | Miami | Florida |
| United States | Medical Research Center of Miami II, Inc | Miami | Florida |
| United States | South Florida Research Phase I-IV, Inc | Miami Springs | Florida |
| United States | Boeson Research | Missoula | Montana |
| United States | Access Clinical Trials, Inc. | Nashville | Tennessee |
| United States | HMH Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Columbia University Medical Center Research Pharmacy | New York | New York |
| United States | Columbia University Pediatric Neuromuscular Center | New York | New York |
| United States | Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit | New York | New York |
| United States | Mount Sinai Hospital - Pharmacy Department | New York | New York |
| United States | Mount Sinai Hospital - Pharmacy Department | New York | New York |
| United States | New York Neurology Associates | New York | New York |
| United States | The Neurological Institute of New York | New York | New York |
| United States | Physicians Research Group (Administrative Office Location) | Noblesville | Indiana |
| United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
| United States | Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology | Norfolk | Virginia |
| United States | Coastal Carolina Research Center | North Charleston | South Carolina |
| United States | Velocity Clinical Research - North Hollywood | North Hollywood | California |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Coastal Clinical Research Specialists | Orange Park | Florida |
| United States | Orlando Health Arnold Palmer Hospital for Children | Orlando | Florida |
| United States | Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice | Orlando | Florida |
| United States | College Park Family Care Center Physician Service Group - Neruology Research Department | Overland Park | Kansas |
| United States | Sharlin Health Neuroscience Research Center | Ozark | Missouri |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | AIM Trials, LLC | Plano | Texas |
| United States | The Neurology Group | Pomona | California |
| United States | North Suffolk Neurology | Port Jefferson Station | New York |
| United States | Providence Brain & Spine Institute-research coordinator's office | Portland | Oregon |
| United States | Providence Health & Services Investigational Drug Services Westside | Portland | Oregon |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Providence St. Vincent Medical Center | Portland | Oregon |
| United States | National Clinical Research, Inc. | Richmond | Virginia |
| United States | Beaumont Hospital, Royal Oak Campus | Royal Oak | Michigan |
| United States | UC Davis | Sacramento | California |
| United States | UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy | Sacramento | California |
| United States | University of California, Davis Clinical and Translational Science Center Clinical Research Center | Sacramento | California |
| United States | University of California, Davis Midtown Clinic | Sacramento | California |
| United States | JBR Clinical Research | Salt Lake City | Utah |
| United States | Wasatch Clinical Research , LLC(Administrative Location) | Salt Lake City | Utah |
| United States | Rady Children's Hospital | San Diego | California |
| United States | Perseverance Research Center, LLC | Scottsdale | Arizona |
| United States | Perseverance Research Center, LLC | Scottsdale | Arizona |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | Seattle Children's Hospital Investigational Drug Services | Seattle | Washington |
| United States | Clinvest Research, LLC | Springfield | Missouri |
| United States | Clinvest Research, LLC | Springfield | Missouri |
| United States | Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford | Connecticut |
| United States | ForCare Clinical Research | Tampa | Florida |
| United States | Physicians Research Group | Tempe | Arizona |
| United States | Pacific Clinical Research Management Group LLC | Upland | California |
| United States | MedVadis Research | Waltham | Massachusetts |
| United States | MedVadis Research Corporation | Waltham | Massachusetts |
| United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
| United States | Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The occurrence of treatment-emergent adverse events, serious adverse events | To evaluate the safety and tolerability of rimegepant in children and adolescents (= 6 to < 18 years of age). | 58 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01430442 -
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
|
Phase 2 |