Phase 3 study of BOTOX for the Prevention of Migraine in Subjects with Episodic Migraine

Phase 1

• Conditions: Episodic Migraine; MedDRA version: 22.0Level: LLTClassification code 10082019Term: Episodic migraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Chemical Phenomena [G02]

• Registration Number: EUCTR2021-001979-16-PL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-23
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 777

Inclusion Criteria

-Adult male or female, 18 to 65 years of age at Visit 1.
-Completed 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 meeting ICHD-3 diagnostic criteria for migraine with aura or migraine without aura (1.1 and 1.2) 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 738
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

-No history of or current diagnosis of the following headache disorders according to ICHD-3:
a. Migraine with brainstem aura (1.2.2) or retinal migraine (1.2.4)
b. Complications of migraine (1.4), chronic tension-type headache (2), trigeminal autonomic cephalalgias (3), hypnic headache (4.9), hemicrania continua (3.4) or new daily persistent headache (4.10)
-No history of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma).
-No history of inadequate response to > 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action (see Section 8.1 of the Operations Manual for the list of medications and criteria for determining inadequate response).
-No unremitting headache lasting continuously throughout the 4-week baseline period.
-No known active Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction [PCR]) test result.
- In addition, if based on the answers to the SARS-CoV-2 Infection Risk Assessment Tool the site considers the subject currently at risk for developing SARS-CoV-2 infection, then the subject should either be tested or advised to come back for study screening after 14 days.
-Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:
•At least 14 days since first negative PCR test result have passed in asymptomatic patients or 14 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.
-For all females of childbearing potential; a negative serum pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2 prior to the first dose of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the efficacy and safety of 2<br>dose levels of BOTOX compared with placebo as migraine prevention in<br>subjects with EM.;Secondary Objective: Not Applicable;Primary end point(s): The primary endpoint is the change from baseline in the frequency of monthly migraine days across Months 5 and 6.;Timepoint(s) of evaluation of this end point: Across Months 5 and 6.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will be as follows (and will be evaluated in the stated order): <br>1. Change from baseline in the frequency of monthly headache days across Months 5 and 6 <br>2. Responder status of 50% reduction from baseline in the frequency of monthly migraine days across Months 5 and 6 <br>3. Change from baseline in the frequency of monthly acute headache medication days across Months 5 and 6 <br>4. Change from baseline in Migraine-Specific Quality-of-Life Questionnaire version 2.1 Role Function – Restrictive domain score at Month 6 <br>5. Change from baseline in the Activity Impairment in Migraine – Diary Physical Impairment domain score across Months 5 and 6 (6-item Headache Impact Test [HIT-6] in Europe) <br>6. Change from baseline in monthly neck pain days associated with headache across Months 5 and 6 among subjects who report at least 1 day of neck pain associated with headache during baseline;Timepoint(s) of evaluation of this end point: Across Months 5 and 6.