Clinical trial NCT04649242: Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Official title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pediatric Migraine
Keywords: Migraine
Acute treatment
Phonophobia
Photophobia
Nausea
Pediatric
Children
Adolescent
Pediatric Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 2100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: To compare rimegepant with placebo for pain freedom in children and adolescents combined.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
timeFrame: Within 24 hours and 48 hours of initial treatment
measure: To compare rimegepant with placebo on sustained pain freedom in adolescents.
timeFrame: 2 to 24 hours post-dose
measure: To compare rimegepant with placebo on sustained pain freedom in adolescents.
timeFrame: 2 to 48 hours post-dose
measure: To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo for pain freedom in children.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.
timeFrame: Within 24 hours and 48 hours of initial treatment.
measure: To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
timeFrame: 2 to 24 hours post-dose
measure: To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
timeFrame: 2 to 48 hours post-dose
measure: To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.
timeFrame: 2 hours post-dose
measure: To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
timeFrame: Time to patients first report of pain relief of none or mild post dose up to 48 hours.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Tempe
country: United States
facility: Physicians Research Group
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: La Jolla
country: United States
facility: University of California, San Diego Altman Clinical Translational Research Institute
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research, LLC
state: California
city: Long Beach
country: United States
facility: Miller Children's & Women's Hospital Long Beach
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research - North Hollywood
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County - Inpatient Pharmacy
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County - Neuroscience Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Sacramento
country: United States
facility: University of California, Davis Midtown Clinic
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
state: California
city: Sacramento
country: United States
facility: University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado- lnvestigational Drug Services
state: Colorado
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners, LLc, dba New England Institute for Clinical Research
state: Connecticut
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delaware
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Apopka
country: United States
facility: Topaz Clinical Research, Inc.
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: DeLand
country: United States
facility: DeLand Clinical Research Unit
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc.
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic LLP
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, Inc
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami II, Inc
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital, Research Institute
state: Florida
city: Miami
country: United States
facility: Brainstorm Research
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Orange Park
country: United States
facility: Coastal Clinical Research Specialists
state: Florida
city: Pembroke Pines
country: United States
facility: Bioresearch Institute
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Childrens Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Rare Disease Research, LLC
state: Georgia
city: Brunswick
country: United States
facility: Pivotal Clinical Research & Associates, LLC
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Chicago Headache Center & Research Institute
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc
state: Illinois
city: Westfield
country: United States
facility: Options Research Group, LLC
state: Indiana
city: Sioux City
country: United States
facility: Meridian Clinical Research, LLC
state: Iowa
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services
state: Iowa
city: Kansas City
country: United States
facility: Clinical Associates Midwest, LLC
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center Physicians Group- Neurology Research Dept.
state: Kansas
city: Lexington
country: United States
facility: Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
state: Kentucky
city: Lexington
country: United States
facility: UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Neurology and Headache Center, Inc.
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health, Helen DeVos Children's Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Wellnow Urgent Care and Research
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital Royal Oak Campus
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Ozark
country: United States
facility: Sharlin Health Neuroscience Research Center
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Great Falls
country: United States
facility: Boeson Research
state: Montana
city: Kalispell
country: United States
facility: Boeson Research LLC
state: Montana
city: Missoula
country: United States
facility: Blue Moose Pediatrics
state: Montana
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Lincoln
country: United States
facility: Alivation Research, LLC.
state: Nebraska
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Neptune
country: United States
facility: HMH Jersey Shore University Medical Center
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Bronx
country: United States
facility: Prime Global Research, LLC
state: New York
city: Commack
country: United States
facility: True North Neurology
state: New York
city: Lake Success
country: United States
facility: Northwell Health/ Division of Pediatric Neurology
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island, Clinical Research Center
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island, Pediatric Neurology
state: New York
city: New York
country: United States
facility: New York Neurology Associates
state: New York
city: New York
country: United States
facility: Weil Cornell Medicine, New York-Presbyterian
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital - Pharmacy Department
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Research Pharmacy
state: New York
city: New York
country: United States
facility: Columbia University Pediatric Neuromuscular Center
state: New York
city: New York
country: United States
facility: Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
state: New York
city: New York
country: United States
facility: The Neurological Institute of New York
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology P.C
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center, PC
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Drug Delivery - Cincinnati Children's Hospital IDS - Denise Lagory
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Wellnow Urgent Care and Research
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Tulsa
country: United States
facility: Lynn Institute of Tulsa
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research, Grants Pass
state: Oregon
city: Portland
country: United States
facility: Providence Brain & Spine Institute-research coordinator's office
state: Oregon
city: Portland
country: United States
facility: Providence Health & Services Investigational Drug Services Westside
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
city: Greenville
country: United States
facility: Premier Neurology, PC
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research - Greenville
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group.
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc.
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Austin
country: United States
facility: Child Neurology Consultants of Austin - South Austin
state: Texas
city: Austin
country: United States
facility: Child Neurology Consultants of Austin - Central Austin
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Future Search Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center, Dallas
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: El Paso
country: United States
facility: ANESC Research
state: Texas
city: El Paso
country: United States
facility: ANRC Research
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
city: Houston
country: United States
facility: Pain and Headache Centers of Texas
state: Texas
city: Houston
country: United States
facility: SCLA Management
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research,LLC.
state: Texas
city: Houston
country: United States
facility: NeuroCare Plus
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research , LLC(Administrative Location)
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC (Regulatory Only)
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Norfolk
country: United States
facility: Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Eastside Therapeutic Resource, Inc. dba Core Clinical Research
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital Investigational Drug Services
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc
state: Wisconsin
city: Madison
country: United States
facility: University Hospital
state: Wisconsin
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Bengbu
country: China
facility: First Affiliated Hospital of Bengbu Medical College Neurology
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: " The First Affiliated Hospital of Chongqing Medical University"
state: Chongqing
city: Lanzhou
country: China
facility: Lanzhou university second hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Jingzhou
country: China
facility: Jingzhou First People's Hospital
state: Hubei
city: Wuhan City
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Children's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Children's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University, Pediatric Neurology
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital Neurology Department
state: Shaanxi
city: Xianyang City
country: China
facility: Yan 'an University Xianyang Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Lu 'an
country: China
facility: Lu 'an People's Hospital
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University School of Medicine
city: Wuhan
country: China
facility: Wuhan Children's Hospital
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgical Clinic
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgical Clinic
state: Fukuoka
city: Kiryu-shi
country: Japan
facility: Hikita Pediatric Clinic
state: Gunma
city: Nishinomiya-shi
country: Japan
facility: Yamaguchi Clinic
state: Hyogo
city: Higashinada-ku Kobe-shi
country: Japan
facility: Konan Medical Center
state: Hyōgo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Kagoshima-shi
country: Japan
facility: Tanaka Neurosurgery & Headache Clinic
state: Kagoshima
city: Taihaku-ku Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Abeno-ku Osaka-shi
country: Japan
facility: Tennoji Dai Brain Clinic
state: Osaka
city: Naniwa-ku
country: Japan
facility: Tominaga Clinic
state: Osaka
city: Chuo-ku Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City
city: Col. Roma Norte
country: Mexico
facility: Clinstile S.A. de C.V.
state: Ciudad DE Mexico
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Reseach Institute, S.C.
state: Estado DE Mexico
city: Culiacan
country: Mexico
facility: Neurociencias Estudios Clinicos S.C.
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Unidad de Investigacion en Salud de Chihuahua S.C.
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
state: Dolnoslaskie
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z.o.o. Medic-R Spolka komandytowa
city: Szczecin
country: Poland
facility: Euromedis Sp. z o. o.
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Centre d'Atencio Primaria Balenya
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Lund
country: Sweden
facility: ProbarE i Lund AB
state: Skåne LÄN [se-12]
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Örebro
country: Sweden
facility: Avdelningen för kliniska Prövningar, Universitetssjukhuset Örebro
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Re:Cognition Health Limited
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: