Phase 2
N=242
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00564681 ↗Enrolled (actual)
242
Serious AEs
6.6%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 — 40.4; 41.5; 39.6; -10.3 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin type A (Biological); botulinum toxin type A Formulation 2 (Biological); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 |
40.4; 41.5; 39.6; -10.3; -13.6; -5.6 | — |
| SECONDARY Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 |
1.3; 1.6; 0.8 | — |
| SECONDARY Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 |
1.3; 1.5; 0.6 | — |
| SECONDARY Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1 |
9.7; 10.0; 9.7; -2.8; -4.1; -1.3 | — |
| SECONDARY Duration of Treatment Effect for Treatment Responders |
111.0; 99.0; 99.0 | — |
Summary
Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cervical dystonia
Exclusion Criteria
- Current or previous botulinum toxin treatment of any type for any condition
Data sourced from ClinicalTrials.gov (NCT00564681). 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.