Status:
COMPLETED
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Blepharospasm
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 sess...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00406367
Start Date
October 1 2006
End Date
July 1 2009
Last Update
March 15 2013
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
David King, MD - Private Practice
Halifax, Nova Scotia, Canada, B3J 3T1