Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia

Status:	Completed
Healthy:	No
Age Range:	30 - 75
Updated:	5/23/2018
Start Date:	September 2015
End Date:	July 17, 2017

This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of
daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).

Inclusion Criteria:

- Meets diagnostic criteria for isolated cervical dystonia

- Has moderate severity with a Baseline TWSTRS-Total score of at least 20 and a
TWSTRS-Severity subscale score or at least 15

- Has been using stable doses of focal dystonia medications for at least 3 months and
willing to continue through end of study

Exclusion Criteria:

- Cervical dystonia attributable to an underlying etiology, such as traumatic
torticollis or tardive torticollis; predominant retrocollis or antecollis cervical
dystonia

- Significant dystonia in other body areas, or is currently being treated with botulinum
toxin for dystonia in other areas than isolated cervical dystonia

- Neurological abnormalities other than cervical dystonia

- History of severe dysphagia or aspiration, or current clinically significant
swallowing disorder

- Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation
surgery in the neck/shoulder region, or intrathecal baclofen

- Marked limitation on passive range of motion that suggests contractures or other
structural abnormality, e.g. cervical contractures or cervical spinal deformity

- Profound atrophy of cervical musculature

- Any neurological condition that may place the subject at increased risk with exposure
to botulinum toxin type A, including peripheral motor neuropathic diseases such as
amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
disorders such as Lambert-Eaton syndrome and myasthenia gravis

- Suboptimal efficacy response to any prior botulinum toxin type A product, when a
previous treatment produced more optimal therapeutic response, as judged subjectively
by the Investigator

- Previous treatment with any botulinum toxin product for any condition within the 6
months prior to Screening and during the study; presence of any blood coagulation
disorder; or on anticoagulation treatment with international normalized ratio (INR) >
3.5

We found this trial at

sites

Wake Forest Baptist Health

Winston-Salem, North Carolina 27157

Phone: 336-716-9056

from

Winston-Salem, NC