Cervical Dystonia
Conditions
Brief summary
The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.
Interventions
DRUGNT 201
Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline \> / = 25 with TWSTRS - severity score \> / = 10 and TWSTRS - disability score \> / = 3 * Patients must be on a stable dose of other medications * For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry * For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit. * For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®. * Age \> / = 18 and \< 76 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4 | From baseline to week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TWSTRS, overall interventional effect | From study baseline to week 14-28, 24-52, 34-76, and 44-100 | Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions |
| Global Assessment of Efficacy by Investigator (GAEI) | Week 10-24, 20-48, 30-72, and 40-96 | At the end of each injection cycle |
| Subject Evaluation of Global Response (PEGR) | Week 10-24, 20-48, 30-72, and 40-96 | At the end of each injection cycle. |
| TWSTRS, Single interventional effect | From week 10-24 to week 14-28, from week 20-48 to week 24-52, from week 30-72 to week 34-76, and from week 40-96 to week 44-100 | Single interventional effect of one injection session by the change of the TWSTRS total, severity and disability scores from each cycle baseline to 4 weeks thereafter. |
| Time from last injection session to waning of treatment effect as rated by subjective subject assessment | Up to 24 weeks from last injection session | Measured in weeks. |
| Duration of treatment effect | Up to 24 weeks from last injection session | Defined as time period within an injection cycle from the day of the injection session until the day where the need for reinjection was indicated by the subject (if subject experienced an onset of treatment effect). |
| Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline | From study baseline up to week 100 | — |
| Time from last injection session to onset of treatment effect as given by subjective subject assessment | Up to 4 weeks from last injection session | Measured in days. |
Countries
Germany
Outcome results
None listed