Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Recruiting · NCT04649242 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
Matching placeboRimegepant/BHV3000
What this trial is about
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
- Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
- Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
- Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- Verbally distinguish between migraine and other types of headaches.
- Participants must have a weight \> 40 kg at the Screening Visit.
- Adequate venous access for blood sampling.
- Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).
Exclusion criteria
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
- History of suicidal behavior or major psychiatric disorder.
- Current diagnosis or history of substance abuse; positive drug test at Screening.
- History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
- Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
- Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
- Current diagnosis of viral hepatitis or a history of liver disease.
- Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
Where it is running
60 locations listed across 38 US states.
- Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama - Birmingham, Alabama, United States
- Perseverance Research Center, LLC - Scottsdale, Arizona, United States
- Physicians Research Group - Tempe, Arizona, United States
- Advanced Research Center, Inc. - Anaheim, California, United States
- Adult & Child Neurology Medical Associates - Costa Mesa, California, United States
- ProScience Research Group - Culver City, California, United States
- Memorial Health Services - Fountain Valley, California, United States
- Neuro-Pain Research Center - Fresno, California, United States
- Altman Clinical and Translational Research Institute, University of California San Diego - La Jolla, California, United States
- Adult & Child Neurology Medical Associates - Long Beach, California, United States
- Miller Children's & Women's Hospital Long Beach - Long Beach, California, United States
- National Research Institute - Los Angeles, California, United States
- Velocity Clinical Research - North Hollywood - North Hollywood, California, United States
- Children's Hospital of Orange County - Inpatient Pharmacy - Orange, California, United States
- Children's Hospital of Orange County - Neuroscience Center - Orange, California, United States
- Children's Hospital of Orange County - Orange, California, United States
- The Neurology Group - Pomona, California, United States
- University of California, Davis Midtown Clinic - 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 (CCRC) - Sacramento, California, United States
- Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location) - San Bernardino, California, United States
- Pacific Clinical Research Management Group LLC - Upland, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Children's Hospital Colorado- lnvestigational Drug Services - Aurora, Colorado, United States
- Children's Hospital Colorado - Aurora, Colorado, United States
- Colorado Springs Neurological Associates, PC - Colorado Springs, Colorado, United States
- Colorado Springs Neurological Associates, PC - Colorado Springs, Colorado, United States
- CT Clinical Research - Cromwell, Connecticut, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Ki Health Partners, LLc, dba New England Institute for Clinical Research - Stamford, Connecticut, United States
- Nemours Children's Hospital, Delaware - Wilmington, Delaware, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- Topaz Clinical Research, Inc. - Apopka, Florida, United States
- Beautiful Minds Clinical Research Center - Cutler Bay, Florida, United States
- DeLand Clinical Research Unit - DeLand, Florida, United States
- Sarkis Clinical Trials - Gainesville, Florida, United States
- Multi-Specialty Research Associates, Inc. - Lake City, Florida, United States
- Watson Clinic Center for Research, Inc. - Lakeland, Florida, United States
- Watson Clinic LLP - Lakeland, Florida, United States
- AppleMed Research Group, LLC - Miami, Florida, United States
- Medical Research Center of Miami II, Inc - Miami, Florida, United States
- South Florida Research Phase I-IV, Inc - Miami, Florida, United States
- Brainstorm Research - Miami, Florida, United States
- Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office - Naples, Florida, United States
- Aqualane Clinical Research - Naples, Florida, United States
- Coastal Clinical Research Specialists - Orange Park, Florida, United States
- Clinical Associates of Orlando, LLC - Orlando, Florida, United States
- Bioresearch Institute - Pembroke Pines, Florida, United States
- Forcare Clinical Research - Tampa, Florida, United States
- Premiere Research Institute at Palm Beach Neurology - West Palm Beach, Florida, United States
- Children's Healthcare of Atlanta, Inc. - Atlanta, Georgia, United States
- Childrens Healthcare of Atlanta - Atlanta, Georgia, United States
- Rare Disease Research, LLC - Atlanta, Georgia, United States
- Pivotal Clinical Research & Associates, LLC - Brunswick, Georgia, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Chicago Headache Center & Research Institute - Chicago, Illinois, United States
- AMR-Baber Research Inc - Naperville, Illinois, United States
- Options Research Group, LLC - Westfield, Indiana, United States
- Velocity Clinical Research, Sioux City - Sioux City, Iowa, United States
- Integrated Clinical Trial Services - West Des Moines, Iowa, United States
Showing 60 of 245 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →