Blepharospasm Short Interval
|ClinicalTrials.gov Identifier: NCT00507637|
Recruitment Status : Terminated (primary efficacy endpoint not attainable.)
First Posted : July 26, 2007
Last Update Posted : February 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Blepharospasm||Drug: NT 201||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2007|
|Primary Completion Date :||February 2008|
|Study Completion Date :||February 2008|
|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).
- 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. ]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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507637
|Bonn, Germany, 53125|
|Principal Investigator:||Bettina Wabbels, MD||Universitaets Augenklinik Bonn|