Clinical Trial for Pediatric Migraine.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Pediatric Migraine

Sex

Male or Female

Age

6 - 17 years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

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.
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.
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

Study overview

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.

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Miles

0500

Nearest Locations found

22 sites found

Adult & Child Neurology Medical Associates

Costa Mesa, California, United States, 92627

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Adult & Child Neurology Medical Associates

Long Beach, California, United States, 90806

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Advanced Research Center, Inc.

Anaheim, California, United States, 92805

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Altman Clinical and Translational Research Institute, University of California San Diego

La Jolla, California, United States, 92037

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Aqualane Clinical Research

Naples, Florida, United States, 34105

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CT Clinical Research

Cromwell, Connecticut, United States, 06416

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Children's Hospital Colorado

Aurora, Colorado, United States, 80045

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Children's Hospital Colorado- lnvestigational Drug Services

Aurora, Colorado, United States, 80045

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Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

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Clinical Associates of Orlando, LLC

Orlando, Florida, United States, 32819

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Ki Health Partners, LLc, dba New England Institute for Clinical Research

Stamford, Connecticut, United States, 06905

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Memorial Health Services

Fountain Valley, California, United States, 92708

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Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States, 90806

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Neuro-Pain Research Center

Fresno, California, United States, 93710

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Perseverance Research Center, LLC

Scottsdale, Arizona, United States, 85253

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South Florida Research Phase I-IV, Inc

Miami, Florida, United States, 33166

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Sunwise Clinical Research

Walnut Creek, California, United States, 94596

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The Neurology Group

Pomona, California, United States, 91767

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Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)

San Bernardino, California, United States, 92408

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Children's Hospital of Orange County

Orange, California, United States, 92868

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Children's Hospital of Orange County - Inpatient Pharmacy

Orange, California, United States, 92868

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Children's Hospital of Orange County - Neuroscience Center

Orange, California, United States, 92868

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Join PfizerConnect

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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