A Phase 2 study for the use of Botox in patients with migraine headaches

  • STATUS
    Recruiting
  • days left to enroll
    36
  • sponsor
    Aeon Biopharma
Updated on 22 March 2021

Summary

This study is for the possible prevention of migraine headaches with Botox (Purified Neurotoxin Complex) injections.

Description

A randomized, multicenter, double-blind, placebo-controlled, Phase 2 study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the prevention of migraine headache.

Details
Condition Migraine (Adult), migraine
Clinical Study IdentifierTX269372
SponsorAeon Biopharma
Last Modified on22 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female patients 18 years or older
Patient has at least a 1-year history of episodic migraine (with or without aura) or chronic migraine (with or without aura)
Age of the patient at the time of migraine onset <50 years
History of, on average _>_ 6 migraine or probable migraine days per month in the 3 months prior to screening
Patient is on a stable dose of medications, if any, used for acute treatment of migraine for at least 3 months prior

Exclusion Criteria

History of migraine accompanied by diplopia or decreased level of consciousness, or retinal migraine
Current diagnosis of chronic tension-type headache, cluster headache or cranial neuropathy
Confounding and clinically significant pain syndromes (eg., fibromyalgia, chronic low back pain)
Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the study
Psychiatric conditions that are uncontrolled and/or untreated
History of alcohol or drug abuse
Hepatitis B or Hep C
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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