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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05028569
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.


Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: BOTOX Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 777 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 5, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Botox Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: BOTOX Dose A
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.
 Drug: BOTOX
Intramuscular Injection
Other Name: Botulinum Toxin Type A
Experimental: BOTOX Dose B
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.
 Drug: BOTOX
Intramuscular Injection
Other Name: Botulinum Toxin Type A
Placebo Comparator: Placebo
Participants will receive placebo on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
 Drug: BOTOX
Intramuscular Injection
Other Name: Botulinum Toxin Type A

Drug: Placebo
Intramuscular Injection


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Frequency of Monthly Migraine Days [ Time Frame: 6 Months ]
    Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.


Secondary Outcome Measures :
  1. Change From Baseline in the Frequency of Monthly Headache Days [ Time Frame: 6 Months ]
    Change from baseline in the frequency of monthly headache days will be assessed.

  2. Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days [ Time Frame: 6 Months ]
    Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.

  3. Change From Baseline in the Frequency of Monthly Acute Headache Medication Days [ Time Frame: 6 Months ]
    The change from baseline in acute migraine medication use days will be assessed.

  4. Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score [ Time Frame: 6 Months ]
    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".

  5. Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score [ Time Frame: 6 Months ]
    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".

  6. 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 [ Time Frame: 6 Months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028569


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05028569    
Other Study ID Numbers: M21-307
2021-001979-16 ( EudraCT Number )
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
URL: https://vivli.org/ourmember/abbvie/

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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
Keywords provided by AbbVie:
Migraine
Episodic Migraine
BOTOX
Botulinum Toxin Type A)
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents