Clinical Trials/NCT01584843

NCT01584843

Completed

Phase 3

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

GlaxoSmithKline1 site in 1 country41 target enrollmentMay 2012

ConditionsStrabismus

InterventionsGSK1358820

DrugsGSK1358820

Overview

Phase: Phase 3
Intervention: GSK1358820
Conditions: Strabismus
Sponsor: GlaxoSmithKline
Enrollment: 41
Locations: 1
Primary Endpoint: Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

June 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\<At the start of screening period\>
•Paralytic or concomitant strabismus. Subjects with paralytic strabismus will be eligible for inclusion only if paralysis has persisted for at least 3 months and strabismus has been developed at one eye
•Horizontal deviations (esotropia or exotropia)
•Strabismus with the (absolute) strabismus angles at both distance and near of primary position \>-10 PD and \<50 PD
•Age\>-12 years at the time of giving informed consent
•The subject has to be capable of giving written informed consent of their own will. For subjects aged less than 20 years, the subject and his/her legally acceptable representative (person in parental authority or guardian) have to give written informed consent
•Either sex. Males have to agree to practice contraception during the study period. Females of child-bearing potential will be eligible for inclusion in this study. However, they have to have negative pregnancy test both at the screening visit and just before initial injection and agree to practice reliable methods of contraception
•QTc \<450 msec; for patients with Bundle Branch Block, QTc \<480 msec based on average QTc value of triplicate ECGs \<At the start of treatment period \>
•Strabismus with the (absolute) strabismus angles at both distance and near of primary position \>-10 PD and \<50 PD
•ALT at the screening visit \<2 x ULN and alkaline phosphatase and bilirubin \<-1.5 x ULN

Exclusion Criteria

•\<At the start of screening period\>
•Secondary strabismus caused by prior surgical recession of the antagonist in past surgical treatment of strabismus
•Strabismus due to abnormal innervations
•Strabismus with thyroid-associated ophthalmopathy
•Strabismus with strong motor limitation of extraocular muscles
•Mechanical limitations of ocular movement due to periorbital disease or due to past surgical treatment other than strabismus
•Blepharoptosis
•Conjunctival pathology
•Systemic neuromuscular junction dysfunction
•Systemic neuromuscular disease

Arms & Interventions

GSK1358820 1.25 U (10-20 PD)

Receive 1.25 U of GSK1358820 on Week 0

Intervention: GSK1358820

GSK1358820 2.5 U (10-20 PD)

Receive 2.5 U of GSK1358820 on Week 0

Intervention: GSK1358820

GSK1358820 2.5 U (20-50 PD)

Receive 2.5 U of GSK1358820 on Week 0

Intervention: GSK1358820

GSK1358820 5.0 U (20-50 PD)

Receive 5.0 U of GSK1358820 on Week 0

Intervention: GSK1358820

Outcomes

Primary Outcomes

Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)

Time Frame: Baseline and Week 4 of the FTP

The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters \[m\]) and the near-view strabismus angle (measured at a distance of 33 centimeters \[cm\]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.

Secondary Outcomes

Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)(Baseline and Week 1 of the FTP)
Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP)
Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)(Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52))
Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP(Weeks 1 and 4 of the FTP)
Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP(Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP)
Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP(Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52))
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP(Baseline and Weeks 1 and 4 of the FTP)
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP)
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP(Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52))
Duration of Effect(Up to Week 48 after the final injection of the FTP (up to Study Week 52))
Severity of Duction Limitation at Weeks 1 and 4 of the FTP(Week 1 and Week 4 of the FTP)
Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP(Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP))
Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP(Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52))
Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP(Baseline and Weeks 1 and 4 of the FTP)
Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP))
Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP(Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52))