What is the mechanism of action of this treatment?

Botulinum toxins, including Botulinum Toxin Type B (MYOBLOC), treat spasticity by inhibiting the release of acetylcholine at the neuromuscular junction. This inhibition prevents muscle contractions, thereby reducing muscle stiffness and spasms. This mechanism is crucial for spasticity patients as it directly addresses the excessive muscle activity that characterizes their condition, improving mobility, reducing pain, and enhancing overall quality of life.

What side effects are associated with this type of intervention?

Common side effects of botulinum toxin treatments for spasticity, such as MYOBLOC (Botulinum Toxin Type B), include localized pain at the injection site, muscle weakness, and transient flu-like symptoms. Specific to botulinum toxin type A, side effects can also include transient weakness in the injected muscles, which may last several weeks. Other potential side effects are stiffness, cramping, and hematoma. These side effects are generally mild to moderate and temporary.

What prior FDA approvals exist?

Botulinum toxins, including Botulinum Toxin Type A (BoNT-A) and Botulinum Toxin Type B (BoNT-B), have been FDA-approved for the treatment of spasticity. BoNT-A, marketed as Botox, Dysport, and Xeomin, is commonly used for managing spasticity in various muscle groups. MYOBLOC (Botulinum Toxin Type B) is another FDA-approved treatment specifically for cervical dystonia and is being studied for its efficacy in treating lower limb spasticity. These treatments work by inhibiting the release of acetylcholine, thereby reducing muscle overactivity and spasticity.

What other types of research exist?

Promising alternatives to MYOBLOC for spasticity treatment in 2024 include abobotulinumtoxinA and onabotulinumtoxinA, which are being studied for their efficacy and safety. Other advanced options include intrathecal baclofen and deep brain stimulation for patients who do not respond to conventional treatments.

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Neurotoxin

MYOBLOC for Spasticity

Phase 2 & 3

Waitlist Available

Research Sponsored by Supernus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Ambulatory (with or without the use of a walking assistive device).

Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; or if unable, the subject's Legally Authorized Representative (LAR) may provide written informed consent.

Must not have

Unresolved fracture(s) in the affected lower limb.

Severe dysphagia (i.e., inability to swallow liquids, solids or both without choking or medical intervention), or dysphagia with a history of aspiration pneumonia, within 6 months before screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and weeks 2, 4, 8, and 13 (and, if applicable, at re-evaluation visit)

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing MYOBLOC, a medication that helps relax muscles, in adults with stiff leg muscles. It works by blocking nerve signals that cause muscle tightness. The study aims to see how safe and effective MYOBLOC is for these patients.

Who is the study for?

Adults aged 18-80 with lower limb spasticity due to stroke, brain injury, or spinal cord injury at least 6 months prior are eligible. They must be able to walk (with aid if needed), have a certain level of muscle stiffness, and commit to the study for a year. Exclusions include severe muscle wasting, recent neurolytic treatments or major surgery, botulinum toxin treatment in the last 24 weeks, uncontrolled epilepsy, and certain medical conditions.

What is being tested?

The trial is testing MYOBLOC's effectiveness and safety in treating adult lower limb spasticity. It's randomized and double-blind: some get MYOBLOC while others receive a placebo. After initial treatment assessment, there's an open-label phase where all participants can receive MYOBLOC.

What are the potential side effects?

MYOBLOC may cause side effects such as weakness in muscles near the injection site, pain at the injection site, flu-like symptoms or general discomfort. Since it’s similar to botulinum toxins used for other conditions like wrinkles or migraines; allergic reactions could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk by myself or with help from a device.

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I understand the study's risks and benefits and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a broken bone in my leg that hasn't healed.

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I have severe trouble swallowing or had pneumonia from choking in the last 6 months.

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I have had surgery on my leg to treat muscle stiffness.

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My lung function test shows severe obstruction.

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I use oxygen as needed or only at night, not on a ventilator 24/7.

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My affected leg is significantly thinner due to muscle loss.

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I have not had major surgery in the last 3 months.

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I do not have any surgeries planned during the study, except for minor skin procedures.

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I haven't received any botulinum toxin treatments and don't plan to, other than MYOBLOC, from when I agree to join the study until it ends.

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I use inhaled corticosteroids regularly.

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I do not have an infection where I will get my injections.

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I have paralysis affecting my arms and legs.

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I have not had seizures or uncontrolled epilepsy in the last year.

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I have a neuromuscular disorder like ALS, MS, or muscular dystrophy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and weeks 2, 4, 8, and 13 (and, if applicable, at re-evaluation visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and weeks 2, 4, 8, and 13 (and, if applicable, at re-evaluation visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 2, 4, 8, and 13 (and, if applicable, at re-evaluation visit) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Effect of MYOBLOC on Modified Ashworth Scale (MAS) Responder Rate Tone of the Ankle Plantar Flexors [Phase 2 and Phase 3]

Gait, Unsteady

Effect of MYOBLOC on the Caregiver Global Impression of Change (GGI-C) [Phase 2 and Phase 3]

+9 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 3; MYOBLOCExperimental Treatment1 Intervention

MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group II: Phase 2; Low Dose MYOBLOCExperimental Treatment1 Intervention

Low Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group III: Phase 2; High Dose MYOBLOCExperimental Treatment1 Intervention

High Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group IV: Phase 2; PlaceboPlacebo Group1 Intervention

Volume-matched placebo is a single treatment

Group V: Phase 3; PlaceboPlacebo Group1 Intervention

Volume-matched placebo is a single treatment

0 / 16Eligibility criteria met

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

Botulinum toxins, including Botulinum Toxin Type B (MYOBLOC), treat spasticity by inhibiting the release of acetylcholine at the neuromuscular junction. This inhibition prevents muscle contractions, thereby reducing muscle stiffness and spasms. This mechanism is crucial for spasticity patients as it directly addresses the excessive muscle activity that characterizes their condition, improving mobility, reducing pain, and enhancing overall quality of life.

Botulinum toxin A prevents the development of contractures in the hereditary spastic mouse.Targeting the neuromuscular junction in skeletal muscles.Treatment in myotonia and periodic paralysis.