Conditions: Essential Tremor of the Upper Limbs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.

Detailed description:

Arms:
arm 1: Single injection cycle, total dose of up to 200 Units, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional). arm 2: Single injection cycle, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).

Interventions: intervention 1: IncobotulinumtoxinA intervention 2: Placebo
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). intervention 2: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Protocol document: