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TERMINATED
NCT04815967
PHASE2/PHASE3

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

Sponsor: Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2021-11-02

Completion Date

2023-04-23

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Phase 2; Low Dose MYOBLOC (10,000 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

Locations (9)

Rancho Research Institute

Downey, California, United States

Idaho Physical Medicine and Rehabilitation

Boise, Idaho, United States

Coastal Neurology

Port Royal, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

National Institute of Medical Rehabilitation

Budapest, Hungary

Specjalistyczna Praktyka Lekarska

Katowice, Poland

Specjalistyczne Gabinety Sp. zo.o

Krakow, Poland

Centrum Medyczne Linden

Krakow, Poland

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed

Lubin, Poland