Cervical Dystonia
Conditions
Brief summary
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of idiopathic CD as determined by the enrolling investigator * If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study * Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews) * Provision of written informed consent prior to enrollment
Exclusion criteria
* Contraindications to treatment with any BoNT-A or BoNT-B preparations * Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction * Anticipated concomitant treatment with BoNT for other than cervical dystonia * Secondary cervical dystonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score | Cycle 1 - Baseline and week 4 |
| Patient Global Impression of Change using the 7-point Likert scale | Cycle 1 - Baseline and week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Waning Effect of Dysport treatment/symptom re-emergence | Cycles 1 to 4 - Week 8 and at study termination visits |
| Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) | Cycles 1 & 3: Baseline |
| Clinical Global Impression of Change using the 7-point Likert scale | Cycle 1 - Week 4 and early termination visit |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit |
| Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS) | Cycles 1 to 4 - Baseline, week 4 and at study termination visits |
| Patient Global Impression of Change using the 7-point Likert scale | Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits |
Countries
United States
Outcome results
None listed