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.

Research Team

Jonathan Rubin, MD,MBA

Principal Investigator

Supernus Pharmaceuticals, Inc.

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.

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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