Conditions: Strabismus
Keywords: Neuromuscular Agents Strabismus Botulinum Toxin Type A
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

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.

Arms:
arm 1: Receive no treatment on Week 0 arm 2: Receive 1.25 U of GSK1358820 on Week 0 arm 3: Receive 2.5 U of GSK1358820 on Week 0 arm 4: Receive no treatment on Week 0 arm 5: Receive 2.5 U of GSK1358820 on Week 0 arm 6: Receive 5.0 U of GSK1358820 on Week 0

Interventions: intervention 1: GSK1358820
Intervention descriptions: intervention 1: IM injection of Botulinum Toxin Type A

Protocol document: