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IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

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ClinicalTrials.gov Identifier: NCT00406367
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : November 16, 2010
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Tracking Information
First Submitted Date  ICMJE November 30, 2006
First Posted Date  ICMJE December 4, 2006
Results First Submitted Date  ICMJE August 31, 2010
Results First Posted Date  ICMJE November 16, 2010
Last Update Posted Date March 15, 2013
Study Start Date  ICMJE October 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) [ Time Frame: Baseline, week 6 ]
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
  • JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
  • JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2006)
Jankovic Rating Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) [ Time Frame: Baseline, week 6 ]
    The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
    • JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
    • JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
  • Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection [ Time Frame: Baseline, week 6 ]
    The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
  • Patient Evaluation of Global Response (PEGR) at Final Visit [ Time Frame: Final visit (up to week 20 after injection of the Main Period) ]
    The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2006)
Jankovic Rating Scale subscores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Blepharospasm
Intervention  ICMJE
  • Drug: incobotulinumtoxinA (Xeomin)
    incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection
  • Drug: Placebo
    Placebo to incobotulinumtoxinA (Xeomin) 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), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Study Arms  ICMJE
  • Experimental: incobotulinumtoxinA (Xeomin)
    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
    Intervention: Drug: incobotulinumtoxinA (Xeomin)
  • Placebo Comparator: Placebo
    Placebo to incobotulinumtoxinA (Xeomin) 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), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2010)
109
Original Enrollment  ICMJE
 (submitted: November 30, 2006)
100
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00406367
Other Study ID Numbers  ICMJE MRZ 60201-0433
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joseph Jankovic, Prof. Houston, Texas
PRS Account Merz Pharmaceuticals GmbH
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP