A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity

PHASE3CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

August 2, 2017

Primary Completion Date

March 20, 2018

Study Completion Date

January 10, 2019

Conditions
Spasticity, Post-Stroke
Interventions
DRUG

Botulinum toxin A (GSK1358820)

GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.

DRUG

Placebo

Placebo injection will contain sodium chloride (0.9 mg).

Trial Locations (38)

465-8620

GSK Investigational Site, Aichi

490-1405

GSK Investigational Site, Aichi

277-8567

GSK Investigational Site, Chiba

279-0021

GSK Investigational Site, Chiba

910-0067

GSK Investigational Site, Fukui

819-8551

GSK Investigational Site, Fukuoka

720-0825

GSK Investigational Site, Hiroshima

734-8530

GSK Investigational Site, Hiroshima

005-0802

GSK Investigational Site, Hokkaido

651-2181

GSK Investigational Site, Hyōgo

300-0028

GSK Investigational Site, Ibaraki

312-0057

GSK Investigational Site, Ibaraki

890-0067

GSK Investigational Site, Kagoshima

227-8518

GSK Investigational Site, Kanagawa

232-0024

GSK Investigational Site, Kanagawa

245-8560

GSK Investigational Site, Kanagawa

259-1143

GSK Investigational Site, Kanagawa

780-0051

GSK Investigational Site, Kochi

862-0924

GSK Investigational Site, Kumamoto

399-6461

GSK Investigational Site, Nagano

945-8585

GSK Investigational Site, Niigata

703-8265

GSK Investigational Site, Okayama

538-0044

GSK Investigational Site, Osaka

570-8507

GSK Investigational Site, Osaka

580-0032

GSK Investigational Site, Osaka

870-0862

GSK Investigational Site, Ōita

849-8501

GSK Investigational Site, Saga

417-0801

GSK Investigational Site, Shizuoka

433-8511

GSK Investigational Site, Shizuoka

770-8503

GSK Investigational Site, Tokushima

102-8798

GSK Investigational Site, Tokyo

105-8471

GSK Investigational Site, Tokyo

123-0853

GSK Investigational Site, Tokyo

165-8906

GSK Investigational Site, Tokyo

192-0032

GSK Investigational Site, Tokyo

201-8601

GSK Investigational Site, Tokyo

641-8509

GSK Investigational Site, Wakayama

992-0057

GSK Investigational Site, Yamagata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03261167 - A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity | Biotech Hunter | Biotech Hunter