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Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Primary Purpose

Episodic Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BOTOX
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Episodic Migraine focused on measuring Migraine, Episodic Migraine, BOTOX, Botulinum Toxin Type A)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for >= 12 months.
  • Onset of migraine before 50 years of age.
  • History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.
  • Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase.
  • Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.

Exclusion Criteria:

  • Current diagnosis of chronic migraine according to ICHD-3.
  • History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
  • History of headache attributed to another disorder (eg, secondary headaches), except medication overuse headache.
  • History of an inadequate response to >4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine.
  • Pregnant or nursing females.

Sites / Locations

  • Neurology and Neurodiagnostics of Alabama /ID# 231918
  • Rehabilitation & Neurological Services /ID# 252441Recruiting
  • Alea Research /ID# 233329
  • Barrow Neurological Institute /ID# 231799
  • Clinical Endpoints /ID# 232625Recruiting
  • Tucson Neuroscience Research /ID# 232288Recruiting
  • Arkansas Clinical Research /ID# 231640Recruiting
  • Woodland International Research Group /ID# 231492Recruiting
  • Hope Clinical Research /ID# 232189Recruiting
  • Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351Recruiting
  • Neuro Pain Medical Center /ID# 231478Recruiting
  • Sun Valley Research Center /ID# 231350Recruiting
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 231908Recruiting
  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337Recruiting
  • Colorado Springs Neurological Associates (CSNA) /ID# 230662Recruiting
  • Summit Headache and Neurologic Institute /ID# 231809Recruiting
  • Advanced Neurosciences Research, LLC /ID# 230658Recruiting
  • Georgetown University Hospital /ID# 232129Recruiting
  • Neurology Offices of South Florida, PLLC /ID# 232281Recruiting
  • Nova Clinical Research, LLC /ID# 245256Recruiting
  • Velocity Clinical Research - Hallandale Beach /ID# 232442Recruiting
  • CNS Healthcare - Jacksonville /ID# 231345Recruiting
  • Brainstorm Research /ID# 243825Recruiting
  • Sensible Healthcare /ID# 231340Recruiting
  • Clinical Neuroscience Solutions, Inc /ID# 231362Recruiting
  • Pain Relief Centers /ID# 232415Recruiting
  • University of South Florida /ID# 231808Recruiting
  • Olympian Clinical Research - Tampa /ID# 239519
  • Accel Research Sites - Tampa Clinical Research Unit /ID# 231670Recruiting
  • Premiere Research Institute - Palm Beach /ID# 230646Recruiting
  • Conquest Research /ID# 232604Recruiting
  • Accel Research Sites Neurostudies /ID# 230665
  • CenExcel iResearch LLC /ID# 231335Recruiting
  • Clinical Research Institute /ID# 239517Recruiting
  • Northwest Clinical Trials /ID# 230657Recruiting
  • Velocity Clinical Research - Boise /ID# 230660Recruiting
  • Robbins Headache Clinic /ID# 230970
  • Josephson-Wallack-Munshower Neurology - PC /ID# 230654Recruiting
  • Deaconess Clinic - Gateway Health Center /ID# 231329Recruiting
  • Accellacare /ID# 231496Recruiting
  • Kansas Institute of Research /ID# 231862Recruiting
  • Ochsner Clinic Foundation /ID# 230645Recruiting
  • Brigham and Women's Faulkner Hospital /ID# 231865Recruiting
  • Boston Clinical Trials /ID# 231367Recruiting
  • Michigan Headache & Neurological Institute (MHNI) /ID# 230659Recruiting
  • Minneapolis Clinic of Neurology - Burnsville /ID# 231780Recruiting
  • StudyMetrix Research /ID# 230642Recruiting
  • Clinvest Research LLC /ID# 252440Recruiting
  • Excel Clinical Research /ID# 232188Recruiting
  • Las Vegas Clinical Trials /ID# 232628Recruiting
  • Albuquerque Clinical Trials, Inc /ID# 231101Recruiting
  • Dent Neurosciences Research Center, Inc. /ID# 252442Recruiting
  • Montefiore Headache Center /ID# 232130Recruiting
  • Fieve Clinical Research, Inc. /ID# 231365Recruiting
  • Upstate Clinical Research Associates /ID# 231343Recruiting
  • Headache Wellness Center /ID# 230819Recruiting
  • M3 Wake Research Inc. /ID# 232285Recruiting
  • Neurology - Triad /ID# 231733Recruiting
  • University of Cincinnati /ID# 231739
  • IPS Research Company /ID# 231085
  • Lynn Health Science Institute (LHSI) /ID# 231349Recruiting
  • Sooner Clinical Research /ID# 231096Recruiting
  • Cutting Edge Research Group /ID# 231095Recruiting
  • Abington Neurological Associates - Abington /ID# 231798Recruiting
  • Lehigh Center for Clinical Research /ID# 231355Recruiting
  • Suburban Research Associates - Media /ID# 231354Recruiting
  • Jefferson Hospital for Neuroscience /ID# 230664Recruiting
  • Frontier Clinical Research /ID# 232623Recruiting
  • Clinical Trials of SC /ID# 231369Recruiting
  • Coastal Carolina Research Center /ID# 231353Recruiting
  • Clinical Neuroscience Solutions - Memphis /ID# 231328Recruiting
  • Nashville Neuroscience Group /ID# 231642Recruiting
  • Austin Clinical Trial Partners /ID# 231092Recruiting
  • Texas Neurology /ID# 230661Recruiting
  • NeuroCare Plus /ID# 252499Recruiting
  • Charlottesville Medical Research /ID# 231368Recruiting
  • Integrated Neurology Services - Falls Church /ID# 244776Recruiting
  • Tidewater Integr Med Research /ID# 231359
  • Sentara Neurology Specialists - Virginia Beach /ID# 231341Recruiting
  • Northwest Clinical Research Center /ID# 231336Recruiting
  • Puget Sound Neurology /ID# 230640Recruiting
  • Frontier Clinical Research - Kingwood /ID# 234127Recruiting
  • CHAMP Clinic /ID# 231635Recruiting
  • Vancouver Island Health Authority /ID# 231992Recruiting
  • Maritime Neurology /ID# 232048
  • Toronto Memory Program /ID# 240006Recruiting
  • Clinique Neuro Levis /ID# 232049Recruiting
  • Fakultni nemocnice u sv. Anny v Brne /ID# 232213Recruiting
  • Nemocnice Jihlava, prispevkova organizace /ID# 232164Recruiting
  • Fakultni nemocnice Ostrava /ID# 232211Recruiting
  • CLINTRIAL s.r.o. /ID# 232208Recruiting
  • DADO MEDICAL s.r.o. /ID# 232157Recruiting
  • Axon Clinical, s.r.o. /ID# 232212Recruiting
  • Fakultni Thomayerova nemocnice /ID# 232214Recruiting
  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472Recruiting
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 239283Recruiting
  • Praxis Dr. Gendolla /ID# 232474Recruiting
  • Universitaetsklinikum Essen /ID# 232478Recruiting
  • Kopfschmerzzentrum Frankfurt /ID# 234066Recruiting
  • Universitaetsklinikum Halle (Saale) /ID# 241506
  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475Recruiting
  • Schmerzklinik Kiel /ID# 232480Recruiting
  • Neurologie Klinikum Großhadern /ID# 232479Recruiting
  • Universitaetsmedizin Rostock /ID# 232471Recruiting
  • The Chaim Sheba Medical Center /ID# 232119Recruiting
  • Tel Aviv Sourasky Medical Center /ID# 232598Recruiting
  • Hillel Yaffe Medical Center /ID# 232122Recruiting
  • Rambam Health Care Campus /ID# 238732Recruiting
  • Shaare Zedek Medical Center /ID# 239485Recruiting
  • Maccabi Healthcare Services /ID# 238605Recruiting
  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355Recruiting
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 251857Recruiting
  • Silmedic Sp. z o.o. /ID# 232358Recruiting
  • Solumed Centrum Medyczne /ID# 238446Recruiting
  • Linden Sp. z o.o. sp.k. /ID# 245685Recruiting
  • Warszawska Klinika Sp. z o.o. /ID# 240612Recruiting
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887Recruiting
  • Hospital Universitario Central de Asturias /ID# 232428Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 232270Recruiting
  • Hospital Universitario Vall d'Hebron /ID# 232268Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
  • Hospital Universitario La Paz /ID# 232495Recruiting
  • Hospital Clinico Universitario de Valladolid /ID# 232272Recruiting
  • Linkoping University Hospital /ID# 234040Recruiting
  • Skaneuro Privatmottagning /ID# 232175Recruiting
  • Neurology Clinic /ID# 234067Recruiting
  • Optimuskliniken /ID# 232174Recruiting
  • Hull University Teaching Hospitals NHS Trust /ID# 242763Recruiting
  • Queen Elizabeth University Hospital /ID# 244870Recruiting
  • NHS Highland /ID# 242855Recruiting
  • Walton Centre /ID# 242857Recruiting
  • St Pancras Clinical Research /ID# 242764Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BOTOX Dose A

BOTOX Dose B

Placebo

Arm Description

Participants will receive BOTOX Dose A on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Participants will receive BOTOX Dose B on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Participants will receive placebo on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Outcomes

Primary Outcome Measures

Change From Baseline in the Frequency of Monthly Migraine Days
Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.

Secondary Outcome Measures

Change From Baseline in the Frequency of Monthly Headache Days
Change from baseline in the frequency of monthly headache days will be assessed.
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days
Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days
The change from baseline in acute migraine medication use days will be assessed.
Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score
Role Function Restrictive (RFR) domain assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time".
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score
AIM-D Physical impairment Domain Score asks participants to rate the level of difficulty experienced with physical impairment using a 6-point rating scale ranging from "not difficult at all" to "I could not do it at all".
Change From Baseline in the Frequency of Monthly Neck Pain Days Associated With Headache Among Participants Who Report at least 1 day of Neck Pain Associated With Headache During Baseline
Change from baseline in the frequency of monthly neck pain days associated with headache will be assessed among participants who report at least 1 day of neck pain associated with headache during baseline.

Full Information

First Posted
August 25, 2021
Last Updated
October 10, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05028569
Brief Title
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Official Title
Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM. BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world. Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine
Keywords
Migraine, Episodic Migraine, BOTOX, Botulinum Toxin Type A)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
777 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BOTOX Dose A
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose A on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
Arm Title
BOTOX Dose B
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose B on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
Intervention Type
Drug
Intervention Name(s)
BOTOX
Other Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
Intramuscular Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular Injection
Primary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Monthly Migraine Days
Description
Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Monthly Headache Days
Description
Change from baseline in the frequency of monthly headache days will be assessed.
Time Frame
6 Months
Title
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days
Description
Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Time Frame
6 Months
Title
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days
Description
The change from baseline in acute migraine medication use days will be assessed.
Time Frame
6 Months
Title
Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score
Description
Role Function Restrictive (RFR) domain assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time".
Time Frame
6 Months
Title
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score
Description
AIM-D Physical impairment Domain Score asks participants to rate the level of difficulty experienced with physical impairment using a 6-point rating scale ranging from "not difficult at all" to "I could not do it at all".
Time Frame
6 Months
Title
Change From Baseline in the Frequency of Monthly Neck Pain Days Associated With Headache Among Participants Who Report at least 1 day of Neck Pain Associated With Headache During Baseline
Description
Change from baseline in the frequency of monthly neck pain days associated with headache will be assessed among participants who report at least 1 day of neck pain associated with headache during baseline.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for >= 12 months. Onset of migraine before 50 years of age. History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1. Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase. Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase. Exclusion Criteria: Current diagnosis of chronic migraine according to ICHD-3. History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. History of headache attributed to another disorder (eg, secondary headaches), except medication overuse headache. History of an inadequate response to >4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine. Pregnant or nursing females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Neurology and Neurodiagnostics of Alabama /ID# 231918
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244-5700
Country
United States
Individual Site Status
Completed
Facility Name
Rehabilitation & Neurological Services /ID# 252441
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805-4046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
256-885-9708
Facility Name
Alea Research /ID# 233329
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012-2707
Country
United States
Individual Site Status
Completed
Facility Name
Barrow Neurological Institute /ID# 231799
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4407
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Endpoints /ID# 232625
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4595
Country
United States
Individual Site Status
Recruiting
Facility Name
Tucson Neuroscience Research /ID# 232288
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710-6152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Arkansas Clinical Research /ID# 231640
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Woodland International Research Group /ID# 231492
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Hope Clinical Research /ID# 232189
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303-1855
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro Pain Medical Center /ID# 231478
City
Fresno
State/Province
California
ZIP/Postal Code
93710-5473
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Valley Research Center /ID# 231350
City
Imperial
State/Province
California
ZIP/Postal Code
92251-9401
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 231908
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Springs Neurological Associates (CSNA) /ID# 230662
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Headache and Neurologic Institute /ID# 231809
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113-3781
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Neurosciences Research, LLC /ID# 230658
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Georgetown University Hospital /ID# 232129
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Offices of South Florida, PLLC /ID# 232281
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428-2231
Country
United States
Individual Site Status
Recruiting
Facility Name
Nova Clinical Research, LLC /ID# 245256
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209-4616
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Hallandale Beach /ID# 232442
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009-4427
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
CNS Healthcare - Jacksonville /ID# 231345
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6039
Country
United States
Individual Site Status
Recruiting
Facility Name
Brainstorm Research /ID# 243825
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2315
Country
United States
Individual Site Status
Recruiting
Facility Name
Sensible Healthcare /ID# 231340
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Clinical Neuroscience Solutions, Inc /ID# 231362
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801-2986
Country
United States
Individual Site Status
Recruiting
Facility Name
Pain Relief Centers /ID# 232415
City
Sun City Center
State/Province
Florida
ZIP/Postal Code
33573-6828
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida /ID# 231808
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympian Clinical Research - Tampa /ID# 239519
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Completed
Facility Name
Accel Research Sites - Tampa Clinical Research Unit /ID# 231670
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Recruiting
Facility Name
Premiere Research Institute - Palm Beach /ID# 230646
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Conquest Research /ID# 232604
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Neurostudies /ID# 230665
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030-2627
Country
United States
Individual Site Status
Completed
Facility Name
CenExcel iResearch LLC /ID# 231335
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute /ID# 239517
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Trials /ID# 230657
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Boise /ID# 230660
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Robbins Headache Clinic /ID# 230970
City
Riverwoods
State/Province
Illinois
ZIP/Postal Code
60015-5711
Country
United States
Individual Site Status
Completed
Facility Name
Josephson-Wallack-Munshower Neurology - PC /ID# 230654
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256-4692
Country
United States
Individual Site Status
Recruiting
Facility Name
Deaconess Clinic - Gateway Health Center /ID# 231329
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare /ID# 231496
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas Institute of Research /ID# 231862
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1363
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Clinic Foundation /ID# 230645
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-8107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Brigham and Women's Faulkner Hospital /ID# 231865
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-3446
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials /ID# 231367
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131-2515
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Headache & Neurological Institute (MHNI) /ID# 230659
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Individual Site Status
Recruiting
Facility Name
Minneapolis Clinic of Neurology - Burnsville /ID# 231780
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337-6732
Country
United States
Individual Site Status
Recruiting
Facility Name
StudyMetrix Research /ID# 230642
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research LLC /ID# 252440
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
417-883-7889
Facility Name
Excel Clinical Research /ID# 232188
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas Clinical Trials /ID# 232628
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030-7187
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Clinical Trials, Inc /ID# 231101
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 252442
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Headache Center /ID# 232130
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-2720
Country
United States
Individual Site Status
Recruiting
Facility Name
Fieve Clinical Research, Inc. /ID# 231365
City
New York
State/Province
New York
ZIP/Postal Code
10017-1921
Country
United States
Individual Site Status
Recruiting
Facility Name
Upstate Clinical Research Associates /ID# 231343
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Headache Wellness Center /ID# 230819
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
M3 Wake Research Inc. /ID# 232285
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612-8106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Neurology - Triad /ID# 231733
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-6984
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati /ID# 231739
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Individual Site Status
Completed
Facility Name
IPS Research Company /ID# 231085
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Completed
Facility Name
Lynn Health Science Institute (LHSI) /ID# 231349
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Sooner Clinical Research /ID# 231096
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Cutting Edge Research Group /ID# 231095
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116-1423
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
405-603-8068
Facility Name
Abington Neurological Associates - Abington /ID# 231798
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Name
Lehigh Center for Clinical Research /ID# 231355
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104-5034
Country
United States
Individual Site Status
Recruiting
Facility Name
Suburban Research Associates - Media /ID# 231354
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063-1760
Country
United States
Individual Site Status
Recruiting
Facility Name
Jefferson Hospital for Neuroscience /ID# 230664
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5191
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research /ID# 232623
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of SC /ID# 231369
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center /ID# 231353
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 231328
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Nashville Neuroscience Group /ID# 231642
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-2646
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Austin Clinical Trial Partners /ID# 231092
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Texas Neurology /ID# 230661
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
NeuroCare Plus /ID# 252499
City
Houston
State/Province
Texas
ZIP/Postal Code
77094-1385
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(832) 275-3360
Facility Name
Charlottesville Medical Research /ID# 231368
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Integrated Neurology Services - Falls Church /ID# 244776
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043-2367
Country
United States
Individual Site Status
Recruiting
Facility Name
Tidewater Integr Med Research /ID# 231359
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
Individual Site Status
Completed
Facility Name
Sentara Neurology Specialists - Virginia Beach /ID# 231341
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456-0019
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center /ID# 231336
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Puget Sound Neurology /ID# 230640
City
Tacoma
State/Province
Washington
ZIP/Postal Code
25328
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research - Kingwood /ID# 234127
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537-9797
Country
United States
Individual Site Status
Recruiting
Facility Name
CHAMP Clinic /ID# 231635
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver Island Health Authority /ID# 231992
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Maritime Neurology /ID# 232048
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3R 1V9
Country
Canada
Individual Site Status
Completed
Facility Name
Toronto Memory Program /ID# 240006
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique Neuro Levis /ID# 232049
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice u sv. Anny v Brne /ID# 232213
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Jihlava, prispevkova organizace /ID# 232164
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava /ID# 232211
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CLINTRIAL s.r.o. /ID# 232208
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
DADO MEDICAL s.r.o. /ID# 232157
City
Praha
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Axon Clinical, s.r.o. /ID# 232212
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice /ID# 232214
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 239283
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis Dr. Gendolla /ID# 232474
City
Essen
ZIP/Postal Code
45133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen /ID# 232478
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kopfschmerzzentrum Frankfurt /ID# 234066
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 241506
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Completed
Facility Name
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Schmerzklinik Kiel /ID# 232480
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Neurologie Klinikum Großhadern /ID# 232479
City
Munich
ZIP/Postal Code
81344
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Rostock /ID# 232471
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 232119
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 232598
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hillel Yaffe Medical Center /ID# 232122
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus /ID# 238732
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center /ID# 239485
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Name
Maccabi Healthcare Services /ID# 238605
City
Kfar Saba
ZIP/Postal Code
4420123
Country
Israel
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 251857
City
Oswiecim
State/Province
Malopolskie
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Silmedic Sp. z o.o. /ID# 232358
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Individual Site Status
Recruiting
Facility Name
Solumed Centrum Medyczne /ID# 238446
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Name
Linden Sp. z o.o. sp.k. /ID# 245685
City
Cracow
ZIP/Postal Code
30-721
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warszawska Klinika Sp. z o.o. /ID# 240612
City
Warszawa
ZIP/Postal Code
02-119
Country
Poland
Individual Site Status
Recruiting
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias /ID# 232428
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 232270
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 232268
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz /ID# 232495
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid /ID# 232272
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Linkoping University Hospital /ID# 234040
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skaneuro Privatmottagning /ID# 232175
City
Lund
ZIP/Postal Code
227 33
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Neurology Clinic /ID# 234067
City
Stockholm
ZIP/Postal Code
114 33
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Optimuskliniken /ID# 232174
City
Upplands Vasby
ZIP/Postal Code
194 61
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Hull University Teaching Hospitals NHS Trust /ID# 242763
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital /ID# 244870
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Highland /ID# 242855
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Walton Centre /ID# 242857
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St Pancras Clinical Research /ID# 242764
City
London
ZIP/Postal Code
EC2Y 8EA
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

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