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Sooner Clinical Research | Oklahoma City, OK

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

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AbbVie

Status and phase

Active, not recruiting
Phase 3

Conditions

Episodic Migraine

Treatments

Drug: Placebo
Drug: BOTOX

Study type

Interventional

Funder types

Industry

Identifiers

NCT05028569
M21-307
2021-001979-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

775 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
  • History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed.
  • History of inadequate response to > 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action.
  • Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

775 participants in 4 patient groups, including a placebo group

Double-Blind, Placebo-Controlled Phase: BOTOX Dose A
Experimental group
Description:
Participants will receive BOTOX Dose A on Week 0 and Week 12.
Treatment:
Drug: BOTOX
Double-Blind, Placebo-Controlled Phase: BOTOX Dose B
Experimental group
Description:
Participants will receive BOTOX Dose B on Week 0 and Week 12.
Treatment:
Drug: BOTOX
Double-Blind, Placebo-Controlled Phase: Placebo
Placebo Comparator group
Description:
Participants will receive placebo on Week 0 and Week 12.
Treatment:
Drug: BOTOX
Drug: Placebo
Open-Label Phase: BOTOX Dose A
Experimental group
Description:
Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
Treatment:
Drug: BOTOX

Trial contacts and locations

135

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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