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MYOBLOC for Spasticity
Study Summary
This trial is testing if MYOBLOC is an effective and safe treatment for upper limb spasticity in adults.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- 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
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
Are new participants being added to this research project currently?
"The given clinical trial is presently recruiting patients, as seen on clinicaltrials.gov. This page was first published on November 16th, 2021 and was last edited March 4th, 2022."
How can I sign up to participate in this research project?
"This clinical trial is seeking 272 participants with multiple sclerosis who are aged between 18 and 80. The most important criteria for applicants are as follows: the subject must be available and able to comply with the study requirements for at least one year, based on the subject's overall health and disease prognosis; the subject must be willing and able to comply with all requirements of the protocol, including completion of study questionnaires (a caregiver may be designated to assist with the physical completion of questionnaires/scales); the subject must understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study ("
In how many different research facilities is this experiment being conducted today?
"Currently, there are 7 clinical trial sites operational for this study. These include Rancho Research Institute in Downey, Nova Clinical Research, LLC in Bradenton, and Coastal Neurology in Port Royal; as well as 4 additional locations."
What are the main goals that researchers are hoping to achieve with this trial?
"According to the primary sponsor of this clinical trial, Supernus Pharmaceuticals, Inc., the study will use the Modified Ashworth Scale (MAS) to measure tone in the Primary Target Muscle Group (PTMG) over a One Year time span. The MAS is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part[s] rigid in flexion or extension). A lower change from baseline MAS score (<0) represents a better outcome..In addition,"
Does this research involve any participants above the age of 60?
"The age requirement to participate in this clinical trial is between 18-80 years old."
Are there any other Phase 3 MYOBLOC studies that have been published?
"This is a phase 3 clinical trial that was initially conducted in 2019 at Vanderbilt University's Department of Neurology. So far, there have been 18,297 completed clinical trials and there are now 3 active studies. A number of these studies are based in Downey, California."
What other research exists on this topic?
"Phase 3; MYOBLOC has been under investigation since as early as 2019 by Supernus Pharmaceuticals, Inc. In that year, the first Phase 3 clinical trial was conducted with 272 participants. After this initial study, Phase 3; MYOBLOC went on to receive approval for Phases 2 and 3 from the FDA in 2019. As of now, there are three active trials taking place across seven cities in two different countries."
Who else is applying?
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What state do they live in?
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How responsive is this trial?
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Most responsive sites:
- New England Institute for Clinical Research: < 48 hours
Average response time
- < 2 Days
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