Clinical trial NCT00406367: IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Official title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Blepharospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharospasm
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.


Eligibility criteria: Main Inclusion Criteria:

* Male or female pretreated outpatients between ages 18 and 80 years (inclusive)
* A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
* A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore \>= 2)
* On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
* Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry
* At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline

Main Exclusion Criteria:

* Atypical variant of BEB caused by inhibition of levator palpebrae muscle
* Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
* The previous two injections with BOTOX® with more than 50 Units per eye
* Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
* Neuroleptic induced blepharospasm
* Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
* Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to Baseline and during the trial

Primary outcomes:
measure: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)
timeFrame: Baseline, week 6
Secondary outcomes:
measure: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)
timeFrame: Baseline, week 6
measure: Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection
timeFrame: Baseline, week 6
measure: Patient Evaluation of Global Response (PEGR) at Final Visit
timeFrame: Final visit (up to week 20 after injection of the Main Period)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Halifax
country: Canada
facility: David King, MD - Private Practice
state: Nova Scotia
Study officials:
affiliation: Houston, Texas
name: Joseph Jankovic, Prof.
role: STUDY_CHAIR
References:
citation: Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm-a randomized trial. Mov Disord. 2011 Jul;26(8):1521-8. doi: 10.1002/mds.23658. Epub 2011 Apr 22.
citation: Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.