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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
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 belowSelect...
I understand the study's risks and benefits and can give my consent.
Select...
I have stiffness in my elbow, wrist, or fingers with a score of 2 or more.
Select...
I understand the study's risks and benefits and can give my consent.
Select...
I am between 18 and 80 years old.
Select...
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:Select...
I am paralyzed in all four limbs or in three limbs including both arms.
Select...
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.
Select...
I have a broken bone in my arm that hasn't healed.
Select...
My affected arm is significantly weaker and thinner.
Select...
I haven't used and won't use any botulinum toxin treatments other than MYOBLOC during the study.
Select...
I have severe trouble swallowing or had pneumonia from choking in the last 6 months.
Select...
I have had surgery to treat muscle stiffness in my arm.
Select...
I do not have any surgeries planned during the study, except for minor skin procedures.
Select...
My lung function test shows severe obstruction.
Select...
I use inhaled corticosteroids regularly.
Select...
I do not have an infection where I will get my injections.
Select...
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)
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 moreTrial 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
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 Ca<sub>v</sub>3.2 Calcium Channel Subunit in Rats with Spinal Cord Injury-Induced Muscle Spasticity.Mechano- and metabosensitive alterations after injection of botulinum toxin into gastrocnemius muscle.
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 Ca<sub>v</sub>3.2 Calcium Channel Subunit in Rats with Spinal Cord Injury-Induced Muscle Spasticity.Mechano- and metabosensitive alterations after injection of botulinum toxin into gastrocnemius muscle.
Find a Location
Who is running the clinical trial?
Solstice NeurosciencesIndustry Sponsor
6 Previous Clinical Trials
854 Total Patients Enrolled
Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,512 Total Patients Enrolled
Azmi Nasser, PhDStudy ChairSupernus Pharmaceuticals
2 Previous Clinical Trials
349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The investigator is willing and able to comply with all requirements of the protocol, including completion of study questionnairesI have severe joint stiffness in my arm that limits movement.You are allergic to botulinum toxin type A or B or any ingredients in MYOBLOC.I have had botulinum toxin treatment in my affected arm within the last 6 months and tolerated it well.I have severe trouble swallowing or had pneumonia from choking in the last 6 months.I am using or willing to use birth control during and for 2 months after the study.My lung function test shows severe obstruction.I use oxygen as needed or only at night, not on a ventilator 24/7.I have a heart condition that my doctor finds significant.I have stiffness in at least two of these muscle groups: elbow, wrist, or fingers.I have had surgery to treat muscle stiffness in my arm.I have had a seizure in the past year.My affected arm is significantly weaker and thinner.I have a neuromuscular disorder such as ALS, MS, or muscular dystrophy.I have not had a nerve pain treatment with agents like phenol or alcohol for my arm in the last year.My cancer was diagnosed within the last 3 months.I have arm stiffness from a stroke, brain injury, or spinal injury that happened over 6 months ago.I haven't used certain antibiotics or muscle function affecting drugs recently.I have arm stiffness from a stroke, brain injury, or spinal injury that happened over 6 months ago.I started or will start physical or occupational therapy less than 30 days before the trial, or I am willing to continue my current therapy through Week 4 of the trial.I have arm stiffness from a stroke, brain injury, or spinal injury that happened over 6 months ago.I haven't used and won't use any botulinum toxin treatments other than MYOBLOC during the study.I have not had major surgery in the last 30 days.I do not have any surgeries planned during the study, except for minor skin procedures.My lab tests show significant abnormal results, especially in kidney or liver function.I understand the study's risks and benefits and can give my consent.Your slow vital capacity is less than 60% of what is expected for someone your age and size.I use inhaled corticosteroids regularly.I am between 18 and 80 years old.I am paralyzed in all four limbs or in three limbs including both arms.I haven't started or changed any muscle relaxant treatments in the last 30 days.I understand the study's risks and benefits and can give my consent.I have a broken bone in my arm that hasn't healed.I do not have an infection where I will get my injections.I have stiffness in my elbow, wrist, or fingers with a score of 2 or more.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2; Low Dose MYOBLOC
- Group 2: Phase 2; High Dose MYOBLOC
- Group 3: Phase 2; Placebo
- Group 4: Phase 3; MYOBLOC
- Group 5: Phase 3; Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04815967 — Phase 2 & 3
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