Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia
|ClinicalTrials.gov Identifier: NCT00541905|
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cervical Dystonia||Drug: NT 201||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||May 2010|
Experimental: NT 201 (50-300 Units)
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.
Drug: NT 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.
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4 [ Time Frame: From baseline to week 4 ]
- TWSTRS, Single interventional effect [ Time Frame: 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.
- TWSTRS, overall interventional effect [ Time Frame: 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) [ Time Frame: Week 10-24, 20-48, 30-72, and 40-96 ]At the end of each injection cycle
- Subject Evaluation of Global Response (PEGR) [ Time Frame: Week 10-24, 20-48, 30-72, and 40-96 ]At the end of each injection cycle.
- Time from last injection session to onset of treatment effect as given by subjective subject assessment [ Time Frame: Up to 4 weeks from last injection session ]Measured in days.
- Time from last injection session to waning of treatment effect as rated by subjective subject assessment [ Time Frame: Up to 24 weeks from last injection session ]Measured in weeks.
- Duration of treatment effect [ Time Frame: 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 [ Time Frame: From study baseline up to week 100 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541905
|Medizinische Hochschule Hannover (LKP)|
|Hannover, Germany, 30625|
|Principal Investigator:||Prof. Dirk Dressler, MD||Hannover Medical School|