Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
Condition: Strabismus
MeSH terms: Strabismus
Intervention: GSK1358820
Intervention description: IM injection of Botulinum Toxin Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Neuromuscular Agents; Strabismus; Botulinum Toxin Type A

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.
    

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

          -  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

          -  Chronic respiratory disorder

          -  Severe muscle weakness or atrophy

          -  Angle-closure glaucoma or its predisposing factors

          -  Severe cardiac, hepatic or renal impairment. The severity refers to Grade 3 according
             to "the Classification of the Severity of Adverse Experiences" (MHLW PAB/SD
             Notification No. 80, dated 29 June 1992).

          -  Surgical operation or hospitalization to be needed during the study period

          -  Female subjects who are pregnant or lactating, who may be pregnant, or who plan for
             pregnancy during the study period

          -  Participation in another clinical study within 6 months prior to enrollment in this
             study or planned participation in another clinical study after enrollment in this
             study

          -  Psychiatric disorder or impairment of intellectual function that may affect the
             subject's ability to give informed consent or to comply with the trial procedures

          -  History of alcohol dependence or drug abuse

          -  Subjects whom the investigator (or sub-investigator) considers ineligible for the
             study