Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

Inclusion Criteria:

• Female or male subject ≥ 18 years and ≤ 85 years at screening

• Diagnosis of lower limb spasticity with or without upper limb spasticity of the samebody side caused by stroke or traumatic brain injury

• Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus

• Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantarflexor of the target lower limb (supine position, knee extended)

• Minimum passive range of motion in ankle of the target lower limb (supine position,knee extended): 10°dorsiflexion and 20°plantarflexion

• At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment ofspasticity or any other condition

• For subjects receiving anticoagulation therapy, the investigator confirms anddocuments that the subject has an:

• Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran orother direct thrombin inhibitors) or

• International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or otheranticoagulants monitored by INR)

Exclusion Criteria:

• Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eatonsyndrome, amyotrophic lateral sclerosis) or any other significant peripheralneuromuscular dysfunction which might interfere with the study

• Bilateral lower limb paresis/paralysis/spasticity ortetraparesis/paralysis/spasticity

• Body weight < 50 kg

• Severe atrophy of the target limb muscles

• Previous, ongoing or planned treatments of spasticity with intrathecal baclofen

• Previous, ongoing, or planned treatments of spasticity in the target lower limb withany of the following procedures: Surgical Intervention; Alcohol or phenol block;Muscle afferent block

• Physiotherapy or use of orthoses or splints at the target limb initiated less than 4weeks before screening or expected to change during the double blind phase of thestudy

• Current or planned treatment with parenterally administered drugs that interferewith neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type musclerelaxants used in anesthesia), or local anesthetics in the treated region within 2weeks prior to screening

• Infection or inflammation at the injection sites

• Subjects with presence or history of aspiration pneumonia, recurrent lowerrespiratory tract infections, or compromised respiratory function as perinvestigator's clinical judgment

• Pregnancy (as verified by a positive pregnancy test) or breast feeding