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Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1) (ASPEN-1)

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ClinicalTrials.gov Identifier: NCT03608397
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 3, 2018
Actual Study Start Date  ICMJE June 20, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Change from Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-total score [ Time Frame: Week 4 and Week 6 ]
TWSTRS is used to assess the severity of cervical Dystonia and the success of its treatment. The average of the change from baseline in TWSTRS-total score at Weeks 4 and 6 will be determined. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03608397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Change from Baseline TWSTRS-total score [ Time Frame: Up to 36 Weeks ]
    Change from baseline in TWSTRS-total score (all post-treatment time points)
  • Duration of effect [ Time Frame: Up to 36 Weeks ]
    Duration of effect based on target TWSTRS score
  • Patient Global Impression of Change (PGIC) Improvement [ Time Frame: Week 4 or Week 6 ]
    Percentage responders at Week 4 or 6
  • Incidence of treatment-emergent adverse events (Safety) [ Time Frame: Up to 36 Weeks ]
    Evaluation of adverse events and serious adverse events over the course of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Change from Baseline TWSTRS-total score [ Time Frame: Up to 36 Weeks ]
    Change from baseline in TWSTRS-total score (all post-treatment time points)
  • Duration of effect Duration of effect [ Time Frame: Up to 36 Weeks ]
    Duration of effect based on target TWSTRS score
  • Patient Global Impression of Change (PGIC) Improvement [ Time Frame: Week 4 or Week 6 ]
    Percentage responders at Week 4 or 6
  • Incidence of treatment-emergent adverse events (Safety) [ Time Frame: Up to 36 Weeks ]
    Evaluation of adverse events and serious adverse events over the course of the study.
Current Other Pre-specified Outcome Measures
 (submitted: July 23, 2018)
  • Change in TWSTRS subscale scores [ Time Frame: Up to 36 Weeks ]
    Change from baseline in TWSTRS subscale scores (TWSTRS-Severity, TWSTRS-Disability, and TWSTRS-Pain) (all post-treatment time points)
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Up to 36 Weeks ]
    CGIC at all post-treatment time points
  • Patient Global Impression of Change (PGIC) [ Time Frame: Up to 36 Weeks ]
    PGIC at all post-treatment time points
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).
Detailed Description Approximately 300 subjects, recruited from approximately 80 study centers in the United States (US), Canada, and Europe will be randomized to DAXI for injection high dose, DAXI for injection low dose, or placebo group, respectively. Subjects will be stratified by treatment center and history of prior treatment with botulinum neurotoxin (BoNT).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Approximately 300 subjects, recruited from study centers in the United States (US), Canada, and Europe will be randomized to DAXI high dose, DAXI low dose or placebo group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blinded
Primary Purpose: Treatment
Condition  ICMJE Cervical Dystonia
Intervention  ICMJE
  • Biological: DaxibotulinumtoxinA for injection
    DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
  • Biological: Placebo
    Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Study Arms  ICMJE
  • Experimental: DAXI for injection low dose
    Low Dose Group
    Intervention: Biological: DaxibotulinumtoxinA for injection
  • Experimental: DAXI for injection high dose
    High Dose Group
    Intervention: Biological: DaxibotulinumtoxinA for injection
  • Placebo Comparator: Placebo
    Placebo Group
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
301
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults, 18 to 80 years of age
  • Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale

Exclusion Criteria:

  • Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
  • Predominant retrocollis or anterocollis CD
  • Significant dystonia in other body areas, or is currently being treated with BoNT for dystonia in areas other than those associated with isolated CD
  • Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
  • Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
  • Previous treatment with any BoNT product for any condition within the 14 weeks prior to Screening
  • Botulinum Neurotoxin Type A (BoNTA), except the investigational daxibotulinumtoxinA, treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator, or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinB [Myobloc/Neurobloc]) injection for CD due to non-response or suboptimal response to BoNTA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nubia Kaba, PhD (510)-742-3599 nkaba@revance.com
Contact: Thai Nguyen-Cleary, MD (510)-742-3622 tncleary@revance.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03608397
Other Study ID Numbers  ICMJE 1720302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Revance Therapeutics, Inc.
Study Sponsor  ICMJE Revance Therapeutics, Inc.
Collaborators  ICMJE Syneos Health
Investigators  ICMJE Not Provided
PRS Account Revance Therapeutics, Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP