Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003410-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT 201 (50-300 Units) | Experimental | NT 201 (Xeomin®, also know as IncobotulinumtoxinA or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT 201 | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TWSTRS, Single interventional effect | 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. | 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 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dirk Dressler, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover (LKP) | Hanover | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Dressler D, Kupsch A, Paus S, Seitzinger A, Gebhardt B. Sustained efficacy of Incobotulinumtoxin-A (Xeomin®; Botulinum Neurotoxin Type-A, free from Complexing Proteins) in Long-Term Treatment of Cervical Dystonia. European Journal of Neurology 18 (Suppl. 2): 482, 2011. | ||
| 23687362 | Result | Dressler D, Paus S, Seitzinger A, Gebhardt B, Kupsch A. Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1014-9. doi: 10.1136/jnnp-2012-303608. Epub 2013 May 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TWSTRS, overall interventional effect |
Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions |
| From study baseline to week 14-28, 24-52, 34-76, and 44-100 |
| Global Assessment of Efficacy by Investigator (GAEI) | At the end of each injection cycle | Week 10-24, 20-48, 30-72, and 40-96 |
| Subject Evaluation of Global Response (PEGR) | At the end of each injection cycle. | Week 10-24, 20-48, 30-72, and 40-96 |
| Time from last injection session to onset of treatment effect as given by subjective subject assessment | Measured in days. | Up to 4 weeks from last injection session |
| Time from last injection session to waning of treatment effect as rated by subjective subject assessment | Measured in weeks. | Up to 24 weeks from last injection session |
| Duration of treatment effect | 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). | Up to 24 weeks from last injection session |
| Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline | From study baseline up to week 100 |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
Not provided
Not provided
Not provided