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

NCT04815967 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2023-03-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Solstice Neurosciences

    collaborator INDUSTRY

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD, MBA · Supernus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2023-07-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States
  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815967 on ClinicalTrials.gov