Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity (NCT04099667) | Clinical Trial Compass
TerminatedPhase 2/3
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Stopped: Company/sponsor business decision; not due to or related to any safety concerns
United States, Hungary, Poland40 participantsStarted 2019-12-17
Plain-language summary
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
. Ambulatory (with or without the use of a walking assistive device).
. Modified Ashworth Scale (MAS) score ≥2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection.
Timeframe: Baseline and Week 4
2
The Clinical Global Impression of Change (CGI-C) Score in Functional Ability at Week 4 Post-injection
Timeframe: Week 4
Trial details
NCT IDNCT04099667
SponsorSolstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
. In the Investigator's opinion, the subject will be available and able to comply with the study requirements for at least 1 year, based on the subject's overall health and disease prognosis.
. In the Investigator's opinion, the subject will 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.
Exclusion criteria
. Quadriplegia/tetraplegia, lower limb diplegia or triplegia.
. Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year.
. Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy.
. History of major joint contracture(s), in which, based on the Investigator's assessment, the contracture(s) significantly contribute(s) to joint immobility in the affected lower limb.
. Unresolved fracture(s) in the affected lower limb.
. Severe atrophy in the affected lower limb.
. Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components.
. Concomitant use or exposure within 5 half-lives of randomization of the following: aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.