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Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in Treatment of Adult Upper Limb Spasticity and Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC

NCT04815967•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.

Detailed Description

Phase 2, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of two doses of MYOBLOC versus volume-matched placebo in the treatment of upper limb spasticity in adults. An interim analysis will evaluate all available safety and efficacy data from the Phase 2 double-blind trial in order to recommend which dose will be evaluated in subsequent Phase 3 trial. The Phase 3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of MYOBLOC versus placebo in the treatment of upper limb spasticity in adults. Subjects who complete either the Phase 2 or Phase 3 trial will continue into an open-label extension where each will receive 5 separate MYOBLOC treatments (\~13 week apart) for upper limb spasticity.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Male or female ≥18 to maximum of 80 years of age, inclusive.
•3. Upper limb spasticity due to stroke, or traumatic brain injury, or spinal cord injury that occurred ≥ 6 months prior to randomization. Eligible subjects may have upper limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
•4. 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.
•5. 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.
•6. 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

•1. Quadriplegia/tetraplegia, or triplegia with both upper limbs affected.
•2. Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year.
•3. Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy.
•4. History of major joint contracture(s), in which, based on the Investigator's assessment, the contracture(s) significantly contributes to joint immobility in the affected upper limb.
•5. Unresolved fracture(s) in the affected upper limb.
•6. Severe atrophy in the affected upper limb.
•7. Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components.
•8. 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.
•9. Treatment with a neurolytic agent (e.g., phenol, alcohol blocks) to the affected upper limb within 1 year before randomization.
•10. Presence of a spinal stimulator or intrathecal baclofen pump that has not been turned off within 30 days prior to screening.
+30 more criteria

Locations (9)

Rancho Research Institute

Downey, California, United States

New England Institute for Clinical Research

Stamford, Connecticut, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Idaho Physical Medicine and Rehabilitation

Boise, Idaho, United States

Coastal Neurology

Port Royal, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Fakultní nemocnice Brno, Neurologická klinika FN Brno (University Hospital Brno, Department of Neurology)

Brno, Czechia

Centrum pro intervenční terapii motorických poruch, Neurologická klinika, Univerzita Karlova Katerinska

Prague, Czechia

Key Dates

Start Date

November 16, 2021

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2024

Last Updated

March 7, 2023

Enrollment

272

ESTIMATED participants

Conditions

SpasticityCerebrovascular AccidentMultiple SclerosisTraumatic Brain InjuryCervical Spinal Cord InjuryCerebral Palsy

Interventions

Phase 2; Low Dose MYOBLOC

DRUG

Phase 2; High Dose MYOBLOC

DRUG

Phase 2; Placebo

DRUG

Phase 3; MYOBLOC

DRUG

Phase 3; Placebo

DRUG

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NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

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NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

Inclusion Criteria

Exclusion Criteria

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