Phase 4
N=283
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01486264 ↗Enrolled (actual)
283
Serious AEs
9.2%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection — -4.1; -2.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Xeomin® (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection |
-4.1; -2.4 | — |
| SECONDARY Change From Baseline in TWSTRS Total Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection |
-8.5; -7.6 | — |
| SECONDARY Change From Baseline in TWSTRS Total Score Based on Unblinded Rater Assessment at Week 4 After the 8th Injection |
-9.4; -10.3 | — |
| SECONDARY Change From Baseline in TWSTRS Severity Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection |
-4.8; -5.1 | — |
| SECONDARY Change From Baseline in TWSTRS Disability Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection |
-1.9; -2.1 | — |
| SECONDARY Change From Baseline in TWSTRS Pain Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection |
-2.7; -3.1 | — |
| SECONDARY Change From Control Visit Week 4 After First Injection in Investigator-Rated Global Response at Week 4 After the 8th Injection |
-0.3; -0.1 | — |
| SECONDARY Change From Control Visit Week 4 After First Injection in Subject-Rated Global Response at Week 4 After the 8th Injection |
0.4; 0.5 | — |
| SECONDARY Change From Control Visit Week 4 After First Injection in Subject Satisfaction Score at Week 4 After the 8th Injection |
-1.2; -0.6 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity |
-0.5; -0.1 | — |
| SECONDARY Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4 After the 8th Injection |
-14.42; -12.45 | — |
| SECONDARY Change From Baseline in CDIP-58 Subscales' Scores at Week 4 After the 8th Injection |
-22.49; -23.70; -13.79; -7.92; -12.79; -9.97 | — |
| SECONDARY Time to Offset of Xeomin Effects by Injection Cycle |
4.8; 5.8; 4.8; 6.8; 5.0; 7.8 | — |
Summary
This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.
Eligibility Criteria
Inclusion Criteria
- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia
Exclusion Criteria
- Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
Data sourced from ClinicalTrials.gov (NCT01486264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.