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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.

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).

Condition or disease Intervention/treatment Phase
Cervical Dystonia Biological: DaxibotulinumtoxinA for injection Biological: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 301 participants
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
Official Title: 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)
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
Experimental: DAXI for injection low dose
Low Dose Group
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.

Experimental: DAXI for injection high dose
High Dose Group
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.

Placebo Comparator: Placebo
Placebo Group
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change from Baseline TWSTRS-total score [ Time Frame: Up to 36 Weeks ]
    Change from baseline in TWSTRS-total score (all post-treatment time points)

  2. Duration of effect [ Time Frame: Up to 36 Weeks ]
    Duration of effect based on target TWSTRS score

  3. Patient Global Impression of Change (PGIC) Improvement [ Time Frame: Week 4 or Week 6 ]
    Percentage responders at Week 4 or 6

  4. 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.


Other Outcome Measures:
  1. 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)

  2. Clinical Global Impression of Change (CGIC) [ Time Frame: Up to 36 Weeks ]
    CGIC at all post-treatment time points

  3. Patient Global Impression of Change (PGIC) [ Time Frame: Up to 36 Weeks ]
    PGIC at all post-treatment time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608397


Contacts
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Contact: Nubia Kaba, PhD (510)-742-3599 nkaba@revance.com
Contact: Thai Nguyen-Cleary, MD (510)-742-3622 tncleary@revance.com

Locations
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United States, Arizona
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85018
Contact: Shana Harshell    602-288-4673    shana.harshell@hriaz.com   
Movement Disorders Center of Arizona Recruiting
Scottsdale, Arizona, United States, 85258-4581
Contact: Susan Ortega    480-526-5441    susan@movementdisorders.us   
United States, California
The Parkinsons and Movement Disorder Institute Recruiting
Fountain Valley, California, United States, 92708
Contact: Rachel Romansik,    714-378-5074    rr@pmdi.org   
Contact: Olivia Tong    714-378-5033    Olivia@pmdi.org   
United States, Florida
Infinity Clinical Research Recruiting
Hollywood, Florida, United States, 33024
Contact: Rebecca Nembhard    954-366-0277    rnembhard@infinityclinicalresearch.com   
Suncoast Neuroscience Associates Recruiting
Saint Petersburg, Florida, United States, 33713-8844
Contact: Chelsea Morris    727-202-2629    cmorris@suncoastneuroresearch.com   
Contact: Cynthia Gilbert-Ssengoba    727-202-2629    cgilbert@suncoastneuroresearch.com   
United States, Kansas
Kansas Institute of Reseach Recruiting
Overland Park, Kansas, United States, 66211-1358
Contact: Nai-Ying Wesley    913-652-6475    nwesley@kcbj.com   
United States, Michigan
QUEST Research Institute Recruiting
Farmington, Michigan, United States, 48334
Contact: Linda Barham    248-957-8940    linda@questri.com   
Contact: Freddrenia Holmes    248-957-8940    freddrenia@questri.com   
United States, South Carolina
Coastal Neurology Recruiting
Port Royal, South Carolina, United States, 29935
Contact: Rentz Gabrielle    843-522-1420    gabby.rentz@gmail.com   
United States, Tennessee
Intrafusion Research Network Recruiting
Cordova, Tennessee, United States, 38018
Contact: Cindy Benzel    901-752-3784    cindy.benzel@intrafusion.com   
United States, Texas
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
Contact: Koni Lopez    512-218-1222    K.lopez@ctncpa.org   
Sponsors and Collaborators
Revance Therapeutics, Inc.
Syneos Health

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03608397     History of Changes
Other Study ID Numbers: 1720302
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Revance Therapeutics, Inc.:
DAXI
Cervical Dystonia
TWSTRS
Toxin

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases