What is the mechanism of action of this treatment?

Botulinum toxin treatments, such as Botulinum Toxin Type B (MYOBLOC), work by inhibiting the release of acetylcholine at the neuromuscular junction, leading to a reduction in muscle spasticity. This is particularly important for Spinal Cord Injury (SCI) patients, as muscle spasticity is a common and debilitating symptom following SCI. By reducing spasticity, botulinum toxin can improve mobility, decrease pain, and enhance the overall quality of life for these patients. The treatment's ability to target specific muscles and provide temporary relief makes it a valuable option in the management of SCI-related spasticity.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury that are similar to MYOBLOC (Botulinum Toxin Type B) include other botulinum toxin formulations like Botulinum Toxin Type A. The known side effects of these treatments can include localized pain at the injection site, muscle weakness, flu-like symptoms, and in rare cases, the spread of toxin effects leading to symptoms such as difficulty swallowing, breathing problems, and generalized muscle weakness. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

Botulinum toxins, including Botulinum Toxin Type A (e.g., Botox) and Botulinum Toxin Type B (e.g., MYOBLOC), have been FDA-approved for the treatment of spasticity, which is a common complication of Spinal Cord Injury (SCI). These toxins work by inhibiting the release of acetylcholine, thereby reducing muscle overactivity. While specific FDA approvals for SCI may not be detailed, these treatments are widely used to manage spasticity in various neurological conditions, including SCI.

What other types of research exist?

Promising alternatives to MYOBLOC for spinal cord injury patients include other botulinum toxin type A formulations such as Botox (onabotulinumtoxinA), Xeomin (incobotulinumtoxinA), and Coretox. Additionally, emerging treatments like high-dose vitamin D supplementation, complementary and alternative medicine approaches (e.g., yoga, mindfulness training), and new pharmacological agents like levosimendan and riluzole show potential in managing spasticity and improving quality of life in spinal cord injury patients.

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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

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.

Modified Ashworth Scale (MAS) scores of ≥2 in at least two muscle groups inclusive of the elbow, wrist, and finger flexors at screening and baseline.

Must not have

Quadriplegia/tetraplegia, or triplegia with both upper limbs affected.

Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year.

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 muscles in their arms. It works by blocking nerve signals that cause muscle tightness. The study will compare MYOBLOC to another treatment to see how well it works and how safe it is.

Who is the study for?

Adults aged 18-80 with upper limb spasticity from stroke, brain injury, or spinal cord injury that happened at least 6 months ago. They must understand the study and consent to participate (or have a representative do so), be able to follow the protocol for a year, and have certain muscle stiffness levels. Excluded are those with severe lung disease, recent drug/alcohol abuse, other medical risks, recent major surgery or botulinum toxin treatment.

What is being tested?

The trial is testing MYOBLOC's effectiveness and safety in treating adult upper limb spasticity compared to placebo. It's a Phase 2/3 randomized controlled trial with double-blind procedures initially followed by an open-label extension for further safety evaluation.

What are the potential side effects?

MYOBLOC may cause side effects such as muscle weakness near where it was injected, pain at the injection site, flu-like symptoms, eye problems like drooping eyelids or blurred vision if it spreads beyond the injection area.

Eligibility Criteria

Inclusion Criteria

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

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

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I have stiffness in my elbow, wrist, or fingers with a score of 2 or more.

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

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I am between 18 and 80 years old.

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I have stiffness in at least two of these muscle groups: elbow, wrist, or fingers.

Exclusion Criteria

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

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I am paralyzed in all four limbs or in three limbs including both arms.

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I have had a seizure in the past year.

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

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

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My affected arm is significantly weaker and thinner.

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I haven't used and won't use any botulinum toxin treatments other than MYOBLOC during the study.

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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 to treat muscle stiffness in my arm.

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

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My lung function test shows severe obstruction.

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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 a heart condition that my doctor finds significant.

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.

Primary study objectives

Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone of the Primary Target Muscle Group (PTMG) [Phase 2 and Phase 3]

Secondary study objectives

Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) Scale [Phase 2 and Phase 3]

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

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

+8 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 / 18Eligibility 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 toxin treatments, such as Botulinum Toxin Type B (MYOBLOC), work by inhibiting the release of acetylcholine at the neuromuscular junction, leading to a reduction in muscle spasticity. This is particularly important for Spinal Cord Injury (SCI) patients, as muscle spasticity is a common and debilitating symptom following SCI. By reducing spasticity, botulinum toxin can improve mobility, decrease pain, and enhance the overall quality of life for these patients. The treatment's ability to target specific muscles and provide temporary relief makes it a valuable option in the management of SCI-related spasticity.

Botulinum toxin paralysis of the orbicularis oculi muscle. Types and time course of alterations in muscle structure, physiology and lid kinematics.Botulinum Toxin Type A Possibly Affects Cav3.2 Calcium Channel Subunit in Rats with Spinal Cord Injury-Induced Muscle Spasticity.Mechano- and metabosensitive alterations after injection of botulinum toxin into gastrocnemius muscle.