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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.
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
Study Summary
This trial is testing whether MYOBLOC is an effective and safe treatment for lower limb spasticity in adults.
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.Check my eligibility
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.See study design
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 belowSelect...
I can walk by myself or with help from a device.
Select...
I understand the study's risks and benefits and can give my consent.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 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
Find a Location
Who is running the clinical trial?
Supernus Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
13,526 Total Patients Enrolled
1 Trials studying Spasticity
272 Patients Enrolled for Spasticity
Solstice NeurosciencesIndustry Sponsor
6 Previous Clinical Trials
962 Total Patients Enrolled
1 Trials studying Spasticity
272 Patients Enrolled for Spasticity
Najeebah Abdul-Musawir, MD,MBAStudy DirectorSupernus Pharmaceuticals, Inc.
3 Previous Clinical Trials
538 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity is abnormal, with a longer QTcF interval than normal.You have a device in your spine that hasn't been turned off in the last 30 days.I have not had a nerve pain treatment with agents like phenol or alcohol in my lower limb in the past year.I have not used certain antibiotics or muscle-relaxing drugs recently.I can walk by myself or with help from a device.I have a broken bone in my leg that hasn't healed.I understand the study's risks and benefits and can give my consent.I am between 18 and 80 years old.I haven't started or changed any muscle relaxant treatments in the last 30 days.I have major joint stiffness that affects my ability to move my leg.I have severe trouble swallowing or had pneumonia from choking in the last 6 months.I have had surgery on my leg to treat muscle stiffness.Your QRS interval is longer than 130 milliseconds.I have received botulinum toxin in my affected leg within the last 6 months and tolerated it well.My lung function test shows severe obstruction.I use oxygen as needed or only at night, not on a ventilator 24/7.Your lab test results are not within the normal range, and the doctor thinks it's important.My affected leg is significantly thinner due to muscle loss.I have not had major surgery in the last 3 months.I do not have any surgeries planned during the study, except for minor skin procedures.Your blood creatinine level is more than 1.5 times the normal limit.You have had issues with using drugs or drinking heavily in the past 6 months.I started using an ankle-foot orthosis less than 30 days ago or have been using one for more than 30 days and will keep using it.I am using or willing to use birth control during and for 2 months after the study.You are allergic to botulinum toxin type A or B or any ingredients in MYOBLOC solution.Your blood test shows that your alanine aminotransferase or aspartate aminotransferase levels are more than two times the normal limit.Your bilirubin level in the blood is higher than normal.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.I started or will start physical or occupational therapy less than 30 days before joining the study, or I am willing to continue my current therapy through Week 4 of the study.Your electrocardiogram (ECG) shows significant abnormality, according to the doctor.I have muscle stiffness in my legs due to a past stroke, brain injury, or spinal cord injury.Your lung function is less than 60% of what is expected for someone your age and size.I use inhaled corticosteroids regularly.My cancer was diagnosed within the last 3 months.I do not have an infection where I will get my injections.You have a specific type of heart block called second- or third-degree atrioventricular block.Your heart is not beating regularly in a way that the doctor thinks is important.I have paralysis affecting my arms and legs.I have not had seizures or uncontrolled epilepsy in the last year.I have a neuromuscular disorder like ALS, MS, or muscular dystrophy.Your PR interval (a measure of the electrical activity of your heart) is longer than 220 milliseconds.You have significant stiffness in the ankle of your affected leg.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2; Placebo
- Group 2: Phase 3; MYOBLOC
- Group 3: Phase 3; Placebo
- Group 4: Phase 2; Low Dose MYOBLOC
- Group 5: Phase 2; High Dose MYOBLOC
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.
Spasticity Patient Testimony for trial: Trial Name: NCT04099667 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being included in this research project?
"Eligibility requirements for this research project include being between 18-80 years old."
Answered by AI
Are there any other ongoing Phase 3 trials for MYOBLOC?
"Out of the 3 ongoing Phase 3 trials, MYOBLOC is being researched in 20 different locations, with most of the live trials taking place in Prague and Texas."
Answered by AI
Is this clinical trial available in many different healthcare facilities throughout Canada?
"UT Southwestern Medical Center in Dallas, Texas, New England Institute for Clinical Research in Stamford, Connecticut, and Nova Clinical Research, LLC in Bradenton, Florida are the primary locations for this study. Additionally, there are 9 other research sites."
Answered by AI
What benefits does this clinical trial promise for patients?
"The sponsor of this clinical trial, Supernus Pharmaceuticals, Inc., is measuring the primary outcome of Clinical Global Impression of Change (CGI-C) in functional ability. This will be done through periodic check-ins 2, 4, 8, and 13 weeks post-injection. Additionally, they will be measuring secondary outcomes including the effect of MYOBLOC on the Patient Global Impression of Change (PGI-C), Patient Global Impression of Severity (PGI-S), and Caregiver Global Impression of Change (GGI-C). Successful therapy will be indicated by lower scores (<"
Answered by AI
Has this sort of therapy been used before?
"Phase 3; MYOBLOC has been under investigation since 2019. The first study, which was sponsored by Supernus Pharmaceuticals, Inc., was completed in 2019 with a pool of 272 participants. After the initial Phase 3; MYOBLOC study in 2019, the medication received Phase 2 & 3 drug approval. Currently, there are 3 ongoing Phase 3 studies being conducted in 7 cities across 2 countries."
Answered by AI
To whom is this experimental therapy available?
"This clinical trial is admitting 272 patients with spasticity aged 18 and 80. Most notable, candidates must meet the following criteria: • 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.• Male or female ≥18 to maximum of 80 years of age, inclusive.• Lower limb spasticity due to stroke, traumatic brain injury, or spinal cord injury that occurred ≥6 months prior to randomization. Eligible subjects may have lower limb"
Answered by AI
Who else is applying?
What state do they live in?
Texas
Connecticut
What site did they apply to?
UT Southwestern Medical Center
University of Texas Southwestern Medical Center
New England Institute for Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
No insurance and spasticity is greatly affecting my mobility and my life. I have a spinal cord injury from a herniated disc in my neck that has caused serious stiffness and spasticity in my right leg. I had a cervical fusion over 15 years to correct the problem but the injury persists and my symptoms have worsened over time, impacting my ability to walk.
PatientReceived no prior treatments
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