MYOBLOC for Spasticity

Palo Alto (17 mi)

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.

I understand the study's risks and benefits and can give my consent.

Exclusion Criteria

I have a broken bone in my leg that hasn't healed.

I have severe trouble swallowing or had pneumonia from choking in the last 6 months.

I have had surgery on my leg to treat muscle stiffness.

My lung function test shows severe obstruction.

I use oxygen as needed or only at night, not on a ventilator 24/7.

My affected leg is significantly thinner due to muscle loss.

I have not had major surgery in the last 3 months.

I do not have any surgeries planned during the study, except for minor skin procedures.

I haven't received any botulinum toxin treatments and don't plan to, other than MYOBLOC, from when I agree to join the study until it ends.

I use inhaled corticosteroids regularly.

I do not have an infection where I will get my injections.

I have paralysis affecting my arms and legs.

I have not had seizures or uncontrolled epilepsy in the last year.

I have a neuromuscular disorder like ALS, MS, or muscular dystrophy.

Treatment Details

The 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.

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