NCT04815967

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

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in Treatment of Adult Upper Limb Spasticity and Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.

Detailed description

Phase 2, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of two doses of MYOBLOC versus volume-matched placebo in the treatment of upper limb spasticity in adults. An interim analysis will evaluate all available safety and efficacy data from the Phase 2 double-blind trial in order to recommend which dose will be evaluated in subsequent Phase 3 trial. The Phase 3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of MYOBLOC versus placebo in the treatment of upper limb spasticity in adults. Subjects who complete either the Phase 2 or Phase 3 trial will continue into an open-label extension where each will receive 5 separate MYOBLOC treatments (\~13 week apart) for upper limb spasticity.

Conditions

• Spasticity
• Cerebrovascular Accident
• Multiple Sclerosis
• Traumatic Brain Injury
• Cervical Spinal Cord Injury
• Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Phase 2; Low Dose MYOBLOC	Intramuscular injections on Day 1
DRUG	Phase 2; High Dose MYOBLOC	Intramuscular injections on Day 1
DRUG	Phase 2; Placebo	Intramuscular injections on Day 1
DRUG	Phase 3; MYOBLOC	Intramuscular injections on Day 1
DRUG	Phase 3; Placebo	Intramuscular injections on Day 1

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2021-03-25
• Last updated: 2023-03-07

Locations

9 sites across 2 countries: United States, Czechia

Regulatory

• FDA-regulated drug study