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

NCT04099667 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

Study results available
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Summary

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

Conditions

  • Spasticity

Interventions

DRUG

Phase 2; Low Dose MYOBLOC (15,000 Units)

Intramuscular injections on Day 1

DRUG

Phase 2; High Dose MYOBLOC (20,000 Units)

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, LLC, a subsidiary of MDD US Operations, LLC

    lead INDUSTRY

Principal Investigators

  • Joseph T Hull, PhD · Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC

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
2019-12-17
Primary Completion
2023-03-24
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Poland

Study Locations

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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 NCT04099667 on ClinicalTrials.gov