Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Launched by PFIZER · Nov 30, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called BHV-3000 for children and teenagers who suffer from moderate or severe migraines. The study aims to see if this medication is safe and effective compared to a placebo (a treatment that doesn't contain active medication). To participate, children and adolescents aged 6 to 17 who have had migraines for over six months and experience 1 to 8 migraine attacks each month may be eligible. They should be able to tell the difference between migraines and other types of headaches and weigh more than 40 kg.
Participants in the trial will receive either the new medication or a placebo and will be monitored to see how well the treatment works and if there are any side effects. It's important to note that certain medical conditions, like a history of specific headaches, psychiatric disorders, or recent surgeries, may prevent someone from joining the study. Families interested in enrolling their child should speak with a healthcare professional for more information on the trial and the potential benefits and risks involved.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 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).
- • 2. 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.
- • 3. 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.
- • 1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
- • 2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- • 3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- • 4. Verbally distinguish between migraine and other types of headaches.
- • 5. Participants must have a weight \> 40 kg at the Screening Visit.
- • 6. Adequate venous access for blood sampling.
- • 7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).
- Exclusion Criteria:
- • 1. History of cluster headache or hemiplegic migraine headache.
- • 2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- • 3. 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.
- • 4. History of suicidal behavior or major psychiatric disorder.
- • 5. Current diagnosis or history of substance abuse; positive drug test at Screening.
- • 6. 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.
- • 7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
- • 8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
- • 9. Current diagnosis of viral hepatitis or a history of liver disease.
- • 10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Hefei, Anhui, China
Culver City, California, United States
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Lake Jackson, Texas, United States
Ningbo, Zhejiang, China
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Wroclaw, , Poland
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Culiacán, Sinaloa, Mexico
Lake City, Florida, United States
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Pomona, California, United States
Oklahoma City, Oklahoma, United States
Salt Lake City, Utah, United States
Kelowna, British Columbia, Canada
Flowood, Mississippi, United States
Krakow, , Poland
North Canton, Ohio, United States
Charlottesville, Virginia, United States
Miami, Florida, United States
Wilmington, Delaware, United States
Waltham, Massachusetts, United States
Québec, , Canada
Stamford, Connecticut, United States
Deland, Florida, United States
Lund, , Sweden
Shenzhen, Guangdong, China
Wuxi, Jiangsu, China
Stamford, Connecticut, United States
Springfield, Missouri, United States
Lund, , Sweden
Missoula, Montana, United States
Haikou, Hainan, China
Frisco, Texas, United States
Tampa, Florida, United States
Shibuya Ku, Tokyo, Japan
Lincoln, Nebraska, United States
East Greenwich, Rhode Island, United States
Nishinomiya Shi, Hyogo, Japan
Charlotte, North Carolina, United States
Greer, South Carolina, United States
Cincinnati, Ohio, United States
Miami, Florida, United States
Bellaire, Texas, United States
Ottawa, Ontario, Canada
Krakow, , Poland
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Jiaxing, Zhejiang, China
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Zapopan, Jalisco, Mexico
Culiacan, Sinaloa, Mexico
Grand Junction, Colorado, United States
Monterrey, Nuevo León, Mexico
Culiacan, Sinaloa, Mexico
Grand Junction, Colorado, United States
Monterrey, Nuevo Leon, Mexico
Naniwa Ku, Osaka Shi, Osaka, Japan
Wuhan, , China
Beijing, Beijing, China
Los Angeles, California, United States
Katowice, , Poland
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Lake Success, New York, United States
Madison, Wisconsin, United States
Sherbrooke, Quebec, Canada
Chongqing, Chongqing, China
Xianyang City, Shaanxi, China
Wroclaw, Dolnoslaskie, Poland
Poznań, , Poland
Leicester, Leics, United Kingdom
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Seattle, Washington, United States
Seattle, Washington, United States
Chongqing, Chongqing, China
Orlando, Florida, United States
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Sacramento, California, United States
Sacramento, California, United States
Lanzhou, Gansu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Chifeng, , China
Lu 'An, , China
Shihezi, , China
Portland, Oregon, United States
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Shijiazhuang, Hebei, China
Jingzhou, Hubei, China
Ningbo, Zhejiang, China
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Barcelona, , Spain
Lund, , Sweden
örebro, , Sweden
London, , United Kingdom
Poznan, , Poland
Neptune, New Jersey, United States
Greenville, South Carolina, United States
Kiryu Shi, Gunma, Japan
Nishinomiya Shi, Hyōgo, Japan
Haikou, Hainan, China
Higashinada Ku Kobe Shi, Hyōgo, Japan
Taihaku Ku Sendai Shi, Miyagi, Japan
Abeno Ku Osaka Shi, Osaka, Japan
La Jolla, California, United States
Naka Ku Hiroshima Shi, Hiroshima, Japan
Hiroshima, , Japan
El Paso, Texas, United States
Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Yinchuan, Ningxia, China
Chuo Ku Saitama Shi, Saitama, Japan
Kansas City, Kansas, United States
Kansas City, Kansas, United States
San Bernardino, California, United States
West Des Moines, Iowa, United States
San Bernardino, California, United States
New York, New York, United States
Naniwa Ku, Osaka, Japan
Birmingham, Alabama, United States
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Commack, New York, United States
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Higashinada Ku Kobe Shi, , Japan
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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