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Trial record 69 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

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

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ClinicalTrials.gov Identifier: NCT02706795
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Torticollis (Spasmodic) Biological: DaxibotulinumtoxinA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : December 7, 2016
Actual Study Completion Date : July 17, 2017


Arm Intervention/treatment
Experimental: Dose A
DaxibotulinumtoxinA
Biological: DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study

Experimental: Dose B
DaxibotulinumtoxinA
Biological: DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study

Experimental: Dose C
DaxibotulinumtoxinA
Biological: DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets diagnostic criteria for isolated cervical dystonia
  • Has moderate severity with a Baseline 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 antecollis 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

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): NCT02706795


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02706795     History of Changes
Other Study ID Numbers: RT002-CL005
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Keywords provided by Revance Therapeutics, Inc.:
Cervical dystonia
Spasmodic torticollis

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