Phase 4
N=10
Botox for Cervical Dystonia Following EMG Mapping
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00773253 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botulinum toxin A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS) |
— | — |
| PRIMARY Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale |
9; 23.5 | — |
Summary
The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.
Eligibility Criteria
Inclusion criteria
- Male or female subjects, 18 to 75 years of age.
- Ability to follow study instructions and complete all required visits.
- Subject meets diagnostic criteria for idiopathic primary cervical dystonia.
- Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.
- Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility.
- Patients will not have received Botulinum toxin within 16 weeks of the start of the study.
- In order to not confound the clinical response to BTX-A injections, all patients enrolled must have been on a stable medication regimen for 30 days. If they are not on medication at the initiation of the study, they will not be started on medication. Patients must be on the same medication regimen through the entire study including assessment of both single lead EMG based injections and "mapping" based injections. Medications cannot be stopped during the study to avoid confounding the clinical response to BTX-A.
Exclusion Criteria
- Known allergy or sensitivity to any of the components in BTX-A.
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Participation in another medication or device study or within 3 months of enrollment in this study.
- Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded.
- Any known evidence of cervical contractures or significant spinal deformity.
Data sourced from ClinicalTrials.gov (NCT00773253). 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.