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CompletedNCT02706795Updated Nov 6, 2019

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

A Phase 2 interventional study of DaxibotulinumtoxinA in Torticollis (Spasmodic), sponsored by Revance Therapeutics, Inc.. Completed at 13 sites in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by Revance Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Torticollis (Spasmodic)

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Keywords

  • Cervical dystonia
  • Spasmodic torticollis
03

In context

Torticollis

139 studies on the registry are indexed under Torticollis; 21 are open to participants now.

This study's enrollment of 37 is below the median of 42 across 93 interventional studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meets diagnostic criteria for isolated cervical dystonia
  • Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (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

Exclusion Criteria:

  • Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    daxibotulinumtoxinA (DAXI) for injection

    DAXI for injection

    Biological: DaxibotulinumtoxinA

Interventions

  • BiologicalDaxibotulinumtoxinA

    Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study

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What researchers measure

Primary outcomes

  1. Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score

    Time frame: Week 4

Secondary outcomes

  1. Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score

    Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24

  2. Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)

    Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24

  3. Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment

    Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24

  4. Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment

    Time frame: Weeks 2, 4, 6, 9, 12, 16, 20, 24

  5. Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)

    Time frame: Post-treatment: Weeks 4, 6, 12, 16, 20, 24

  6. Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)

    Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24

07

Study locations

13 sites
  • The Parkinson's & Movement Disorder Institute
    Fountain Valley, California 92708, United States
  • Colorado Springs Neurological Associates
    Colorado Springs, Colorado 80907, United States
  • University of Florida Center for Movement Disorders & Neurorestoration
    Gainesville, Florida 32607, United States
  • Precision Research Organization
    Miami Lakes, Florida 33016, United States
  • University of South Florida
    Tampa, Florida 33613, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Kansas City Bone & Joint Clinic
    Overland Park, Kansas 66211, United States
  • The NeuroMedical Center Clinic
    Baton Rouge, Louisiana 70810, United States
  • Wake forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
  • Riverhills Healthcare, Inc.
    Cincinnati, Ohio 45212, United States
  • Coastal Neurology
    Port Royal, South Carolina 29935, United States
  • Parkinson's Disease Center and Movement Disorder Clinic
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun. PubMed 30009213 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02706795
Lead sponsor
Revance Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 11, 2016
Start date
Sep 2015
Primary completion
Dec 7, 2016
Completion
Jul 17, 2017
Last update
Nov 6, 2019

Study contacts

Nubia Kaba
study director · Sponsor GmbH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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