Conditions: Leg Spasticity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 388
Healthy volunteers: no

Brief summary:
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

Detailed description:

Arms:
arm 1: 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle) arm 2: 1500 U, I.M., on day 1 (single treatment cycle) arm 3: I.M., on day 1 (single treatment cycle)

Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: I.M. injection on day 1 (single treatment cycle) intervention 2: I.M. injection on day 1 (single treatment cycle)

Protocol document: