Phase 4
Completed N=145
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Spasmodic Torticollis
Source: ClinicalTrials.gov NCT00528541 ↗
Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Dysphagia Incidence Over 10 Weeks — 10; 12 Number of patients
Summary
The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dysphagia Incidence Over 10 Weeks |
10; 12 | — |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4 |
40.0; 39.5; 22.0; 25.0 | — |
| SECONDARY Physician Assessment of Cervical Dystonia Severity at Week 4 |
6.0; 7.0; 2.0; 3.0 | — |
| SECONDARY Global Assessment of Benefit by Physician at Week 4 |
3.0; 3.0 | — |
| SECONDARY Global Assessment of Benefit by Patient at Week 4 |
3.0; 3.0 | — |
| SECONDARY Patient Assessment of Need for Retreatment at Week 4 |
54; 54; 19; 15; 1; 1 | — |
| SECONDARY Patient Visual Analog Assessment of Pain at Week 4 |
30.5; 39.5; 8.0; 13.0 | — |
| SECONDARY Physician Comparison of Benefit to Previous Injections at Week 10 |
0; 0; 0; 1; 7; 7 | — |
| SECONDARY Patient Comparison of Benefit to Previous Injections at Week 10 |
0; 0; 1; 2; 8; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
- Successfully treated previously with botulinum toxin type A
Exclusion Criteria
- Breast feeding, pregnant or could become pregnant
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol, alcohol for cervical dystonia
Data sourced from ClinicalTrials.gov (NCT00528541). 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. Informational only — not medical advice.