Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.; US WorldMeds LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; rimabotulinumtoxinB

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.