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

  • STATUS
    Recruiting
  • End date
    Nov 26, 2022
  • sponsor
    Abbvie
Updated on 21 April 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 on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult male or female, 18 to 65 years old
Complete at least 20 out of 28 days in the e-Diary during the screening/baseline phase
Negative result on the urine drug and alcohol screen at Visit 1 unless explained by permitted concomitant medication use (e.g., opioids prescribed for migraine pain
History of migraine headache disorder with or without aura
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
6 to 14 migraine days during the 4-week screening/baseline phase
<15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase
No current diagnosis of chronic migraine
No history of or current diagnosis of the following headache disorders
Migraine with brainstem aura or retinal migraine
Complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache
No history of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache is allowed
No history of inadequate response to >4 prophylactic treatment for migraine, 2 of which have different mechanisms of action
No unremitting headache lasting continuously throughout the 4-week baseline period
No concurrent pain condition that may significantly impact current headache disorder (e.g., fibromyalgia, craniofacial pain, TMD/TMJ)
Subject must not have Patient Health Questionnaire (PHQ-9) score ≥ 15 at Visit 1
No significant risk of self-harm in the past 6 months prior to Visit 1
No concurrent psychiatric conditions including bipolar disorder, schizophrenia, dementia, or other significant neurological disorders
No presence or history of any medical condition that may place the subject at increased risk following exposure to BOTOX or interfere with the study evaluation, including
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
Facial nerve palsy
Infection or dermatological condition at the site of study intervention injection
Any significant eyebrow or eyelid ptosis at Day 1
No history of clinically significant drug or alcohol abuse within 6 months of Visit 1
Must not have a condition or be in a situation which may put the participant at significant risk, may confound study results, or may interfere significantly with the participant's participation in the study
No known active SARS-CoV-2 infection
No unremitting symptoms of "Long COVID" due to prior SARS-CoV-2 infection r any other lasting symptoms that may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
Participants that have received a SARS-CoV-2 vaccination must have completed their final dose of the vaccine at least 14 days prior to Day 1 (study drug administration)
Participant has not received any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) before the first dose of the study drug and is not currently enrolled in another clinical study
Females of childbearing potential must have a negative serum pregnancy test at Visit 1 and 2 prior to the first dose of study drug
Females of childbearing potential must practice 1 protocol-specified method of birth control, that is effective from Visit 1 through at least 90 days after the last dose of study drug
Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days of last dose of study drug
No use of opioids or barbiturates >2 days/month or any gepant in the 3 months prior to Visit 1 or during the baseline or screening phase
No prior use of ANY botulinum toxin (any serotype, therapeutic, or cosmetic) injections in the head, face, and/or neck in the subject's lifetime
No prior use of ANY botulinum toxin (any serotype, therapeutic, or cosmetic) regardless of location in the 6 months prior to Visit 1
No concurrent use or use of any migraine prophylactic treatment in the 4 weeks prior to Visit 1 nor during the baseline or screening phase
No use of CGRP monoclonal antibody in the 6 months prior to screening
No concurrent use or use of acupuncture, TENS (e.g., Cefaly Dual), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles in the 4 weeks prior to Visit 1
Participant must not have received immunization for any botulinum toxin serotype nor have a history of botulism
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