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

NCT01584843 | Completed Phase 3 Results

• 1 other identifier: 116246
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 13

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.

Conditions

Strabismus

Keywords

Neuromuscular Agents; Strabismus; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and Week 4 of the FTP

Secondary Outcomes (16)

• 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

Study Arms (6)

Non-treatment (10-20 PD)

NO INTERVENTION

Receive no treatment on Week 0

GSK1358820 1.25 U (10-20 PD)

ACTIVE COMPARATOR

Receive 1.25 U of GSK1358820 on Week 0

Drug: GSK1358820

GSK1358820 2.5 U (10-20 PD)

ACTIVE COMPARATOR

Receive 2.5 U of GSK1358820 on Week 0

Drug: GSK1358820

Non-treatment (20-50 PD)

NO INTERVENTION

Receive no treatment on Week 0

GSK1358820 2.5 U (20-50 PD)

ACTIVE COMPARATOR

Receive 2.5 U of GSK1358820 on Week 0

Drug: GSK1358820

GSK1358820 5.0 U (20-50 PD)

ACTIVE COMPARATOR

Receive 5.0 U of GSK1358820 on Week 0

Drug: GSK1358820

Interventions

GSK1358820 DRUG

IM injection of Botulinum Toxin Type A

Also known as: Botulinum Toxin Type A

GSK1358820 1.25 U (10-20 PD); GSK1358820 2.5 U (10-20 PD); GSK1358820 2.5 U (20-50 PD); GSK1358820 5.0 U (20-50 PD)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \<At the start of screening period\>
• 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
• 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

You may not qualify if:

• \<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
• Past treatment with botulinum toxin
• Planned injections of botulinum toxin for other indication(s) or for cosmetic purpose during the study period
• Known hypersensitivity to any of the drugs to be used in the study or history of allergy
• Treatment with antibiotics with neuromuscular junction inhibitory action such as aminoglycosides, polypeptides, tetracyclines and lincomycins, except those contained in topical antibacterial formulations
• Treatment with muscle relaxants or drugs with muscle relaxant action

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Aichi, 494-0001, Japan

Location

GSK Investigational Site

Fukuoka, 812-0011, Japan

Location

GSK Investigational Site

Hyōgo, 663-8501, Japan

Location

GSK Investigational Site

Kagoshima, 890-0046, Japan

Location

GSK Investigational Site

Kanagawa, 252-0375, Japan

Location

GSK Investigational Site

Miyazaki, 880-0035, Japan

Location

GSK Investigational Site

Miyazaki, 885-0051, Japan

Location

GSK Investigational Site

Osaka, 535-0021, Japan

Location

GSK Investigational Site

Osaka, 569-8686, Japan

Location

GSK Investigational Site

Shizuoka, 431-3192, Japan

Location

GSK Investigational Site

Tokyo, 101-0062, Japan

Location

GSK Investigational Site

Tokyo, 134-0088, Japan

Location

GSK Investigational Site

Yamaguchi, 750-0061, Japan

Location

MeSH Terms

Conditions

Strabismus

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 24, 2015
• Results First Posted: August 1, 2014

Record last verified: 2015-03

Locations

JP (13)