NCT02706795CompletedPhase 2
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
Revance Therapeutics, Inc.26 sites in 1 country37 target enrollmentStarted: September 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Revance Therapeutics, Inc.
- Enrollment
- 37
- Locations
- 26
- Primary Endpoint
- Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)(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(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)(Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24)
- Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score(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(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)(Post-treatment: Weeks 4, 6, 12, 16, 20, 24)
Investigators
Study Sites (26)
Loading locations...
Similar Trials
Recruiting
Phase 1
A Study of IMC008 for Advanced Solid TumorsAdvanced Solid TumorNCT05837299Changhai Hospital18
Recruiting
Phase 1
A Phase 1 Study of LNCB74 in Advanced Solid TumorsOvarian CancerEndometrial CancerBiliary Tract CancerAdvanced or Metastatic Solid TumorsNon-Small Cell Lung CancerBreast CancerNCT06774963NextCure, Inc.145
Completed
Phase 1
Phase I Study of the Proteosome Inhibitor CEP 18770 in Patients With Solid Tumours or Non-Hodgkin's LymphomasSolid TumorsLymphoma, Non-HodgkinNCT00572637Ethical Oncology Science55
Completed
Phase 2
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212CancerNCT01072175Novartis Pharmaceuticals430
Completed
Phase 1
Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular DystrophyBecker Muscular DystrophyNCT04386304Epirium Bio Inc.22