Episodic Migraine: Phase 3 Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects with Episodic Migraine

  • STATUS
    Recruiting
  • sponsor
    Abbvie
Updated on 27 November 2022

Summary

The purpose of this study is to see if the study drug, BOTOX®, is safe and helps prevent episodic migraines in adults that experience 6-14 migraine days per month and less than 15 headache days per month. This study is for research purposes only. This study will help the sponsor, AbbVie, to learn about BOTOX® safely and effectiveness when compared to placebo (a substance that looks like a drug but has no drug in it) in people experiencing episodic migraines.
Participants are being asked to participate in a research study for a drug called Botulinum Toxin Type A (BOTOX®). They study drug has been approved by the regulatory authorities for use in people with chronic migraine and other specific medical conditions but is not approved with chronic migraine and other specific medical conditions but is not approved for the prevention of episodic migraines. Therefore, the use of the study drug is investigational (experimental) for the purposes of this study. This study is being conducted approximately 125 research centers in 10 countries. Approximately 777 adult men and women with episodic migraines will be selected to participate in this study. Overall participation in this study will be approximately 52 weeks (12 months), which includes 4-week screening/baseline phase, a 24-week double-blind, placebo-controlled phase, and a 24-week open-label phase.
 

Description

Study Period 1: Screening/Baseline
In order to determine eligibility to participate in the study, participants will need to
complete the screening procedures (activities, tests and evaluations) described here:
● Read, review, sign and date this Informed Consent Form
● Collection of Medical History, including but not limited to, questions regarding migraine headache history, surgical history, tobacco, alcohol and drug use.
● Physical Exam.
● Vital Signs (blood pressure and heart rate), height and weight measured.
● Urine and blood for routine laboratory safety, pregnancy, drugs of abuse, and alcohol tests
● Review of any current or past medications
● Collection of demographic information such as your race and date of birth. May need to ask other personal questions.
● Various assessments and questions that measure headache symptoms and experiences and suicidality
● Completion of daily e-Diary entries and questionnaires on a handheld device while at home
 
Period 2: Double-Blind Phase
If eligible to participate in this study, there will be several office and telephone visits during which the participant will receive study medication and/or complete one or more of the study procedures described above in the screening/baseline period.
● Participants will be randomly assigned to one of three study drug groups using the help of a computer program
● BOTOX® 195 U
● BOTOX® 155 U
● Placebo (inactive substance)
● Clinic for visits:
● Day 1 (Visit 2) - first study treatment
● Week 12 (Visit 5) - second study treatment
● Week 48 (Visit 14) - study exit visit (for completion or prematurely discontinue from the study)
● Telephone visits:
● Week 4 (Visit 3)
● Week 8 (Visit 4)
● Week 16 (Visit 6)
● Week 20 (Visit 7)
● Participants will have to complete daily e-Diary entries and questionnaires on a handheld device while at home
● Safety will be assessed throughout the study
 
Period 3: Open-Label Phase
Participants that complete Period 2 may be eligible to continue to the open-label study treatment phase at Week 24 (Visit 8); there will be several office and telephone visits during which the participant will receive study medication and/or complete one or more of the study procedures described above in the screening/baseline period.
● Open-label study treatment is BOTOX® 195 U
● Clinic for visits:
● Week 24 (Visit 8) - first open-label study treatment
● Week 36 (Visit 11) - second open-label study treatment
● Week 48 (Visit 14) - study exit visit (for completion or prematurely discontinue from the study)
● Telephone visits:
● Week 28 (Visit 9)
● Week 32 (Visit 10)
● Week 40 (Visit 12)
● Week 44 (Visit 13)

Details
Condition Migraine (Adult)
Clinical Study IdentifierTX296749
SponsorAbbvie
Last Modified on27 November 2022

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