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

October 30, 2019 updated by: Revance Therapeutics, Inc.
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: daxibotulinumtoxinA (DAXI) for injection
DAXI for injection
Biological: DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
Time Frame: Week 4
Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)
Time Frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
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
Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
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
Weeks 2, 4, 6, 9, 12, 16, 20, 24
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
Post-treatment: Weeks 4, 6, 12, 16, 20, 24
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
Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revance Therapeutics, Inc.

Investigators

  • Study Director: Nubia Kaba, Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

July 17, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT002-CL005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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