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An Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Followed by an Open-Label Multiple-Treatment Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099667
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Brief Summary:
Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of single-dose MYOBLOC over a 1-year duration in adult subjects with lower limb spasticity, followed by an open-label extension safety study of multiple doses.

Condition or disease Intervention/treatment Phase
Spasticity Drug: rimabotulinumtoxinB Drug: Placebo Phase 2 Phase 3

Detailed Description:
Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of a single-dose of MYOBLOC over a 1-year duration in adult subjects with lower limb monoplegia or hemiplegia spasticity due to stroke or TBI, followed by an open-label extension safety study of multiple doses. The primary goal is to assess efficacy of MYOBLOC versus placebo in the treatment of adult lower limb spasticity. The secondary goals are: to establish a safe and efficacious dose of MYOBLOC (administered intramuscularly as a single total dose, to assess the duration of therapeutic response of MYOBLOC after a single administration, and to evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations at 13-week intervals over a minimum duration of 1 year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Followed by an Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 2: MYOBLOC 15,000 U, IM
Subjects will receive a single total limb dose of 15,000 Units of MYOBLOC via intramuscular (IM) injection into the ankle plantar flexor muscles of the affected lower limb on Day 1 with safety and efficacy monitored over the course of 13 weeks. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension for a total of 4 additional treatments.
Drug: rimabotulinumtoxinB
IM injection on Day 1
Other Names:
  • MYOBLOC
  • botulinum toxin type B

Experimental: Phase 2: MYOBLOC 20,000 U, IM
Subjects will receive a single total limb dose of 20,000 Units of MYOBLOC via IM injection into the ankle plantar flexor muscles of the affected lower limb on Day 1 with safety and efficacy monitored over the course of 13 weeks. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension for a total of 4 additional treatments.
Drug: rimabotulinumtoxinB
IM injection on Day 1
Other Names:
  • MYOBLOC
  • botulinum toxin type B

Placebo Comparator: Phase 2: Placebo
Subjects will receive a single total dose of volume-matched placebo via IM injection into the ankle plantar flexor muscles of the affected lower limb on Day 1 with safety and efficacy monitored over the course of 13 weeks. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension for a total of 4 additional treatments.
Drug: Placebo
IM injection on Day 1

Experimental: Phase 3: recommended Phase 3 dose (RP3D)
Subjects will receive the recommended dose of MYOBLOC (determined after analysis of the Phase 2 data) via IM injection into the ankle plantar flexor muscles of the affected lower limb on Day 1 with safety and efficacy monitored over the course of 13 weeks. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension for a total of 4 additional treatments.
Drug: rimabotulinumtoxinB
IM injection on Day 1
Other Names:
  • MYOBLOC
  • botulinum toxin type B

Placebo Comparator: Phase 3: Placebo
Subjects will receive a single total dose of volume-matched placebo via IM injection into the ankle plantar flexor muscles of the affected lower limb on Day 1 with safety and efficacy monitored over the course of 13 weeks. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension for a total of 4 additional treatments.
Drug: Placebo
IM injection on Day 1




Primary Outcome Measures :
  1. Change from baseline (Day 1) in tone of the ankle plantar flexors as measured by the Modified Ashworth Scale (MAS) [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
  2. Clinical Global Impression of Change (CGI-C) in functional ability [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
    CGI-C will be used to record change or improvement of illness (spasticity) on a 7-point scale ranging from "very much improved" to "very much worse".


Secondary Outcome Measures :
  1. Change from baseline (Day 1) in Patient Global Impression of Change (PGI-C) [ Time Frame: Weeks 2, 4, 8, and 13 post injection ]
    The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (spasticity) on a 7-point scale ranging from "very much improved" to "very much worse".

  2. Change from baseline (Day 1) in Caregiver Global Impression of Change (GGI-C) [ Time Frame: Weeks 2, 4, 8, and 13 post injection ]
    The GGI-C scale will be used by the caregiver to rate the impression of change in the subject's overall ability to function on a 7-point scale ranging from "very much improved" to "very much worse".

  3. Change from baseline (Day 1) in Numeric Rating Scale of Pain Intensity (Pain-NRS) [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
    The Pain-NRS will be used to record the intensity of pain in the subject's lower limb identified for treatment using an 11-point scale ranging from "no pain" to "worst pain imaginable".

  4. Change from baseline (Day 1) in Walking Impairment Questionnaire (WIQ) [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
    The WIQ will be used by the subject to record the degree of physical difficulty he/she experiences in walking distance, walking speed, and stair climbing.

  5. Change from baseline (Day 1) in Walking and Resting Comfort Scale (WRCS) [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
    The WRCS will be used by the subject to record the degree of comfort he/she experiences in walking and resting on a 5-point scale ranging from "very comfortable" to "very uncomfortable".

  6. Change from baseline (Day 1) in Patient Global Impression of Severity (PGI-S) [ Time Frame: Weeks 2, 8, and 13 post-injection ]
    The PGI-S scale will be used by the subject to rate the severity of his/her illness (spasticity) on a 7-point scale ranging from "normal" to "among the most extremely ill".

  7. Change from baseline (Day 1) in Caregiver Global Impression of Severity(GGI-S) [ Time Frame: Weeks 2, 8, and 13 post-injection ]
    The GGI-S scale will be used by the caregiver to rate the impression of change in the subject's overall severity of illness (spasticity) on a 7-point scale ranging from "normal" to "among the most extremely impaired".

  8. Change from baseline (Day 1) in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Weeks 2, 8, and 13 post-injection ]
    The CGI-S scale will be used to record the severity of illness (spasticity) on a 7-point scale ranging from "normal" to "among the most extremely ill patients".

  9. Change from baseline (Day1) in responder analysis [ Time Frame: Weeks 2, 4, 8, and 13 post-injection ]
    A subject with at least a 1-point decrease in the MAS score in the ankle plantar flexors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 to 80 years of age (inclusive).
  2. Lower limb spasticity due to stroke or traumatic brain injury (TBI) that occurred at least 6 months prior to study. May have lower limb monoplegia or hemiplegia.
  3. Able to walk (with or without the use of a walking assistive device).
  4. Modified Ashworth Scale (MAS) score greater than or equal to 2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.

Exclusion Criteria:

  1. Quadriplegia/tetraplegia, lower limb diplegia or triplegia.
  2. Uncontrolled epilepsy with a seizure(s) within the last 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 Investigator assessment, the contracture(s) significantly contributes to joint immobility in the target limb.
  5. Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components.
  6. Application of an ankle-foot orthosis (AFO) within 30 days before screening. Subjects regularly using an AFO 30 days or more before screening must be willing to maintain use of the AFO through Week 4 of the DBP of the study.
  7. Prior botulinum toxin type A (BoNT/A) or B (BoNT/B) treatment in the lower limb identified for treatment within 24 weeks before screening. Prior BoNT/A or BoNT/B treatment in areas other than the target limb is not exclusionary but must have occurred at least 12 weeks before screening. Prior toxin exposure must have been well-tolerated and without any significant long-term side effects in the case of repeated prior exposure.
  8. Severe dysphagia (i.e., inability to swallow liquids, solids, or both without choking or without medical intervention), or dysphagia with a history of aspiration pneumonia, within 6 months before screening.
  9. Obstructive pulmonary disease with forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <70%.
  10. Slow vital capacity <60% of predicted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099667


Locations
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United States, Connecticut
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Florida
Nova Clinical Research, LLC
Bradenton, Florida, United States, 34209
United States, Tennessee
Vanderbilt University Dept. of Neurology
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
US WorldMeds LLC
Investigators
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Study Director: Art Wamil, MD US WorldMeds Medical Monitor
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Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT04099667    
Other Study ID Numbers: SN-SPAS-202
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by US WorldMeds LLC:
Stroke
Traumatic Brain Injury (TBI)
Monoplegia
Hemiplegia
Lower limb
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
rimabotulinumtoxinB
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents