~44 spots leftby Apr 2026

MYOBLOC for Spasticity

Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Supernus Pharmaceuticals, Inc.
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing MYOBLOC, a medication that helps relax muscles, in adults with stiff leg muscles. It works by blocking nerve signals that cause muscle tightness. The study aims to see how safe and effective MYOBLOC is for these patients.

Eligibility Criteria

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.

Inclusion Criteria

I can walk by myself or with help from a device.
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.
I understand the study's risks and benefits and can give my consent.
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Exclusion 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.
See 38 more

Treatment Details

Interventions

  • MYOBLOC (Neurotoxin)
  • Placebo ()
  • rimabotulinumtoxinB (Neurotoxin)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Vanderbilt University Dept. of NeurologyNashville, TN
UT Southwestern Medical CenterDallas, TX
Idaho Physical Medicine and RehabilitationBoise, ID
Rancho Research InstituteDowney, CA
More Trial Locations
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Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
Solstice NeurosciencesIndustry Sponsor

References