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Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naïve Subjects With Blepharospasm
This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve. In this study, BTX treatment-naïve subjects are defined as those who have not received BTX treatment within the last 12 months for the treatment of BEB. This definition aims to avoid bias by comparison of treatment effects in the subject's assessments. Furthermore, this study will substantiate the existing efficacy and safety database for the indication BEB.
Details
| Lead sponsor | Merz Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 61 |
| Start date | 2013-11 |
| Completion | 2016-11 |
Conditions
- Bilateral Blepharospasm (BEB)
Interventions
- IncobulinumtoxinA (Xeomin), 25 Units
- IncobotulinumtoxinA (Xeomin), 12.5 Units
- Placebo
- IncobotulinumtoxinA (Xeomin), 35 Units
Primary outcomes
- Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) — Baseline, Day 43 (Visit 4)
JRS severity subscore was used to classify individual symptoms of blepharospasm and to determine therapeutic efficacy. JRS severity subscore ranges from 0 to 4, where 0: None; 1: increased blinking present with external stimuli; 2: Mild but spontaneous eyelid fluttering, definitely noticeable, possibly embarrassing, but not functionally disabling, 3: Moderate, very noticeable spasm of eyelids only, mildly incapacitating, 4: Severe, incapacitating spasm of eyelids and possibly other facial muscles. Values represent least square (LS) mean differences between baseline and visit 4 resulting from analysis of covariance (ANCOVA) with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates and missings replaced using the last observation carried forward (LOCF) method. Negative values denote improvement, while positive values denote deterioration vs. baseline.
Countries
Greece, Malaysia, Sri Lanka