Blepharospasm Short Interval
The objective of this Phase II study is to show that pre-treated patients with BEB with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated NT 201 injections at short injection intervals. In addition, the tolerability of repeated shortened NT 201 administrations in patients with BEB including the development of neutralizing antibodies will be investigated.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Open-label, Single-arm, Single-center Trial to Investigate the Tolerability of NT 201 and Quality of Life of Patients in the Treatment of Blepharospasm With Shortened Injection Intervals|
- The difference between the actual Blepharospasm Disability Index [BSDI] value at each follow up visit and the BSDI value at baseline. [ Time Frame: From baseline up to week 62. Follow up visits include 8 injection visits (V2 to V8) with intervals of at least 6 weeks between injections. ] [ Designated as safety issue: No ]The BSDI includes 6 items to be assessed by a 5-point scoring (i.e., 0-4 points per item) ranging from "no impairment, "slight impairment", "moderate impairment", "severe impairment" to "no longer possible due to my illness". The 6 items are "Driving a vehicle", "Reading", "Watching TV", "Shopping", "Walking" and "Doing everyday activities".
- Change in Jankovic Rating Scale (JRS) score from baseline over time. [ Time Frame: From baseline up to week 62 ] [ Designated as safety issue: No ]The JRS ranges from 0-8 points and consists of the two items "Severity" and "Frequency" with five rating categories each (0-4 points).
- Patient Evaluation of Global Response [PEGR] rated by patient at visits V2 to V8 and at follow-up visit [ Time Frame: Week 6 up to week 62 ] [ Designated as safety issue: No ]The PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from "complete abolishment of signs and symptoms" (+4) down to "very marked worsening" (-4).
|Study Start Date:||August 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
|Experimental: NT 201 (IncobotulinumtoxinA/Xeomin®)||
Drug: NT 201
Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507637
|Bonn, Germany, 53125|
|Principal Investigator:||Bettina Wabbels, MD||Universitaets Augenklinik Bonn|