Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex

Dystonia is a movement disorder which is characterized by sustained, involuntary muscle
contractions which frequently causes twisting and repetitive movements or abnormal postures
of the trunk, neck, face, or arms and legs. In focal dystonia, the abnormal movements
involve a single area of the body. A commonly described form of focal dystonia is cervical
dystonia (CD). Botulinum toxin treatment can be offered as a treatment option for the
treatment of CD.

The current practice for botulinum toxin injection treatment is to inject patients every 3
months. However, not all patients receive continuing benefit from botulinum toxin injections
for an entire 3 months. In a recent survey, approximately 45% of patients report that they
would prefer a treatment cycle of less than 10 weeks.This study will compare Xeomin®, a
botulinum toxin treatment, in shorter treatment intervals (Short Flex dosing) to the
standard interval dosing (Long Flex dosing) to determine if the response to treatment is
comparable in both how it works and any side effects. Xeomin® is approved by the United
States Food and Drug Administration (FDA) for the treatment of CD. The use of Xeomin® is
investigational in regards to shorter treatment intervals. An investigational use is one
that is not approved by the FDA.

The purpose of this research study is to evaluate the efficacy of the Short Flex dosing of
Xeomin® compared to the Long Flex dosing regimen of Xeomin®, using a standard scale
completed by the doctors and subjects as well as questionnaires that ask subjects to rate
symptoms of CD.

Inclusion Criteria:

- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

Exclusion Criteria:

- Current treatment with botulinum toxin of any type for any other indication
(including aesthetic indications) and for any body region during the study.