Phase 3; MYOBLOC for Spasticity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Spasticity+1 More
Phase 3; MYOBLOC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether MYOBLOC is an effective and safe treatment for lower limb spasticity in adults.

Eligible Conditions
  • Spasticity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 21 Secondary · Reporting Duration: Weeks 2, 4, 8, and 13 post injection

Baseline and Week 4
Effect of MYOBLOC on Modified Ashworth Scale (MAS) Responder Rate Tone of the Ankle Plantar Flexors [Phase 2 and Phase 3]
Effect of MYOBLOC on the Numeric Rating Scale of Pain (Pain-NRS) [Phase 2 and Phase 3]
Week 2
Effect of MYOBLOC on the Clinical Global Impression of Severity (CGI-S) [Phase 2 and Phase 3]
Week 2
Gait, Unsteady
Effect of MYOBLOC on the Caregiver Global Impression of Severity (GGI-S) [Phase 2 and Phase 3]
Pain
Effect of MYOBLOC on the Patient Global Impression of Severity (PGI-S) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Walking Impairment Questionnaire (WIQ) [Phase 2 and Phase 3]
The Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for Tone of the Ankle Plantar Flexors [Phase 2 and Phase 3]
Week 2
Change from baseline (Day 1) in Caregiver Global Impression of Change (GGI-C)
Change from baseline (Day 1) in Patient Global Impression of Change (PGI-C)
Week 2
Pain
Change from baseline (Day 1) in Walking Impairment Questionnaire (WIQ)
Change from baseline (Day 1) in Walking and Resting Comfort Scale (WRCS)
Change from baseline (Day 1) in tone of the ankle plantar flexors as measured by the Modified Ashworth Scale (MAS)
Change from baseline (Day1) in responder analysis
Clinical Global Impression of Change (CGI-C) in functional ability
Week 2
Effect of MYOBLOC on the Patient Global Impression of Change (PGI-C) [Phase 2 and Phase 3]
Week 2
Effect of MYOBLOC on the Caregiver Global Impression of Change (GGI-C) [Phase 2 and Phase 3]
Week 2
Change from baseline (Day 1) in Caregiver Global Impression of Severity(GGI-S)
Change from baseline (Day 1) in Clinical Global Impression of Severity (CGI-S)
Change from baseline (Day 1) in Patient Global Impression of Severity (PGI-S)
Week 2
The Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) in functional ability [Phase 2 and Phase 3]

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

10 Treatment Groups

Phase 3: recommended Phase 3 dose (RP3D)
1 of 10
Phase 2: MYOBLOC 20,000 U, IM
1 of 10
Phase 2: MYOBLOC 15,000 U, IM
1 of 10
Phase 3; MYOBLOC
1 of 10
Phase 2; High Dose MYOBLOC
1 of 10
Phase 2; Low Dose MYOBLOC
1 of 10
Phase 3; Placebo
1 of 10
Phase 3: Placebo
1 of 10
Phase 2: Placebo
1 of 10
Phase 2; Placebo
1 of 10

Experimental Treatment

Non-Treatment Group

272 Total Participants · 10 Treatment Groups

Primary Treatment: Phase 3; MYOBLOC · Has Placebo Group · Phase 2 & 3

Phase 3: recommended Phase 3 dose (RP3D)
Drug
Experimental Group · 1 Intervention: rimabotulinumtoxinB · Intervention Types: Drug
Phase 2: MYOBLOC 20,000 U, IM
Drug
Experimental Group · 1 Intervention: rimabotulinumtoxinB · Intervention Types: Drug
Phase 2: MYOBLOC 15,000 U, IM
Drug
Experimental Group · 1 Intervention: rimabotulinumtoxinB · Intervention Types: Drug
Phase 3; MYOBLOC
Drug
Experimental Group · 1 Intervention: Phase 3; MYOBLOC · Intervention Types: Drug
Phase 2; High Dose MYOBLOC
Drug
Experimental Group · 1 Intervention: Phase 2; High Dose MYOBLOC · Intervention Types: Drug
Phase 2; Low Dose MYOBLOC
Drug
Experimental Group · 1 Intervention: Phase 2; Low Dose MYOBLOC · Intervention Types: Drug
Phase 3; Placebo
Drug
PlaceboComparator Group · 1 Intervention: Phase 3; Placebo · Intervention Types: Drug
Phase 3: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Phase 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Phase 2; Placebo
Drug
PlaceboComparator Group · 1 Intervention: Phase 2; Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 2, 4, 8, and 13 post injection

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
43 Previous Clinical Trials
7,931 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.
2 Previous Clinical Trials
374 Total Patients Enrolled
Jonathan Rubin, MD,MBAStudy ChairSupernus Pharmaceuticals, Inc.

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study
You are male or female 18 or older.\n
Subjects must have lower limb spasticity due to stroke, traumatic brain injury, or spinal cord injury that occurred ≥6 months prior to randomization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.