IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

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Brief Title

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)

Secondary Outcome

 Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)

Condition

Blepharospasm

Intervention

incobotulinumtoxinA (Xeomin)

Study Arms / Comparison Groups

 incobotulinumtoxinA (Xeomin)
Description:  incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

109

Start Date

October 2006

Completion Date

July 2009

Primary Completion Date

April 2008

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Joseph Jankovic, Prof., , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00406367

Organization ID

MRZ 60201-0433


Responsible Party

Sponsor

Study Sponsor

Merz Pharmaceuticals GmbH


Study Sponsor

Joseph Jankovic, Prof., Study Chair, Houston, Texas


Verification Date

March 2013