What side effects are associated with this type of intervention?

Common treatments for migraines that inhibit acetylcholine release at the neuromuscular junction, such as onabotulinumtoxinA, can cause side effects including injection site pain, neck pain, and muscle weakness. Other neuromodulation treatments like transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have been associated with mild adverse events such as tingling, redness, and muscle spasms. Serious adverse events are rare for these treatments.

What prior FDA approvals exist?

OnabotulinumtoxinA (Botox) is an FDA-approved treatment for chronic migraine that works by inhibiting the release of acetylcholine at the neuromuscular junction, thereby reducing muscle contractions and associated pain. This treatment is administered via intramuscular injections every three months. Other similar treatments include various forms of neurostimulation, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS), which have shown efficacy in clinical trials but are generally considered second-line treatments. These neurostimulation devices are also FDA-approved for migraine management.

What other types of research exist?

Promising novel alternatives to IncobotulinumtoxinA for migraine patients include CGRP (calcitonin gene-related peptide) inhibitors such as Erenumab, Fremanezumab, and Galcanezumab. These medications have shown efficacy in reducing migraine frequency and do not require refrigeration, making them suitable for patients with limited access to cold storage.

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Neurotoxin

BOTOX® vs. XEOMIN® for Chronic Migraine

Phase 3

Recruiting

Led By Kathleen T Tilman, MD

Research Sponsored by Naval Medical Center Camp Lejeune

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks + baseline

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a new treatment for chronic migraines in military personnel and their families. The treatment involves injections into the head and neck to reduce the frequency and severity of migraines. This new treatment is particularly aimed at those who have not responded to other treatments.

Who is the study for?

This trial is for Department of Defense beneficiaries aged 18-89 with chronic migraines, experiencing at least 15 headache days per month. Participants must have tried and not responded to two different migraine medications, be able to give informed consent in English, and attend follow-up visits. Pregnant or breastfeeding individuals, those allergic to botulinum toxin, on certain medications or with specific medical conditions are excluded.

What is being tested?

The study compares BOTOX® (onabotulinumtoxinA), an FDA-approved treatment requiring refrigeration, with XEOMIN® (incobotulinumtoxinA), which doesn't need cooling and is effective off-label for migraines. The goal is to find a viable treatment option that's easier to store especially for military personnel in the field.

What are the potential side effects?

Potential side effects from both treatments may include localized pain at injection sites, muscle weakness near where the medicine was injected, drooping eyelids, skin tightness or paresthesia ('pins and needles' sensation). Rarely more serious reactions can occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks + baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks + baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks + baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Headache

Secondary study objectives

Differences in Health-Related Quality of Life

Headache

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IncobotulinumtoxinA (XEOMIN®)Experimental Treatment1 Intervention

IncobotulinumtoxinA (XEOMIN®) Group: Administration consists of 31 injections (5 incobotulinumtoxinA (XEOMIN®) units per injection, for a total of 155 units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.

Group II: OnabotulinumtoxinA (BOTOX®)Active Control1 Intervention

OnabotulinumtoxinA (BOTOX®) Group: Administration consists of 31 injections (5 onabotulinumtoxinA (BOTOX®) units per injection, for a total of 155units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraine, such as IncobotulinumtoxinA, work by inhibiting acetylcholine release at the neuromuscular junction, which helps reduce muscle contractions and potentially decreases migraine frequency and severity. Sodium valproate and topiramate, both anticonvulsants, stabilize neuronal activity and prevent migraine attacks by modulating neurotransmitter release and neuronal excitability. Nonpharmacologic interventions like acupuncture and neuromodulation aim to alter pain pathways and reduce migraine frequency through physical and electrical stimulation. Understanding these mechanisms is crucial for migraine patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.