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Completed

NCT Number: NCT02706795

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

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

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Key information

Conditions

Torticollis (Spasmodic) Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DaxibotulinumtoxinA

Biological

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

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

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 11, 2016
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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