NCT01584843

Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus

A Multicenter, Randomized, Evaluator-masked, Parallel-group, Non-treatment-controlled Study Followed by an Open-label Study to Evaluate Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position.

Detailed description

Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position. Secondary objective is to evaluate the efficacy and safety of repeated-dose treatment with GSK1358820 in patients with strabismus.

Conditions

• Strabismus

Interventions

Type	Name	Description
DRUG	GSK1358820	IM injection of Botulinum Toxin Type A

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-07-01
• Completion: 2014-06-01
• First posted: 2012-04-25
• Last updated: 2015-07-24
• Results posted: 2014-08-01

Locations

13 sites across 1 country: Japan