Botulinum Toxin A to Treat Arm Tremor

Inclusion Criteria

• •Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as follows:
• •* Bilateral postural tremor with or without kinetic tremor, involving hands and forearms, that is visible and persistent.
• •* It is to be noted that:
• •* Tremor of other body parts may be present in addition to upper limb tremor.
• •* Bilateral tremor may be asymmetric.
• •* Tremor is reported by patient to be persistent, although the amplitude may fluctuate.
• •First onset of essential tremor at least 6 months before screening with stability of the tremor symptoms over 4 weeks and in the opinion of the investigator definite diagnosis of essential tremor.
• •Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level, corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories (scale part C, items 16-23) in the limb to be treated between of 2 or higher.
• •Visible tremor at wrist level in at least one of the four positions/tasks used in kinematic assessments
• •Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a treatment of up to three joints of the selected upper limb (wrist treatment mandatory).
• •Stable concomitant anti-tremor medication and no clinically relevant findings in routine laboratory examinations.