Blepharospasm Short Interval

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Brief Title

Blepharospasm Short Interval

Official Title

Prospective, Open-label, Single-arm, Single-center Trial to Investigate the Tolerability of NT 201 and Quality of Life of Patients in the Treatment of Blepharospasm With Shortened Injection Intervals

Brief Summary

      The objective of this Phase II study is to show that pre-treated patients with BEB with the
      need of shortened injection intervals achieve an improved and stable quality of life level if
      they receive repeated NT 201 injections at short injection intervals. In addition, the
      tolerability of repeated shortened NT 201 administrations in patients with BEB including the
      development of neutralizing antibodies will be investigated.

Study Phase

Phase 2

Study Type


Primary Outcome

The difference between the actual Blepharospasm Disability Index [BSDI] value at each follow up visit and the BSDI value at baseline.

Secondary Outcome

 Change in Jankovic Rating Scale (JRS) score from baseline over time.




NT 201

Study Arms / Comparison Groups

 NT 201 (IncobotulinumtoxinA/Xeomin®)


* 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


Estimated Enrollment


Start Date

August 2007

Completion Date

February 2008

Primary Completion Date

February 2008

Eligibility Criteria

        Inclusion Criteria:

          -  A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic,
             intermittent or persistent involuntary contractions of the orbicular oculi muscles

          -  Medical need for treatment with shortened injection intervals (< 12 weeks) confirmed
             by the patient and investigator

          -  Blepharospasm Disability Index (BSDI) at baseline visit before injection of > / = 1,6

        Exclusion Criteria:

          -  Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle
             (apraxia of the eyelid)

          -  Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton
             syndrome), as well as amyotrophic lateral sclerosis or any other significant
             neuromuscular disease which might interfere with the trial

          -  The previous three injections with Botulinum toxin Type A with more than 50 Units [U]
             per eye per injection session

          -  Treatment with Botulinum toxins for any indication other than BEB within 4 months
             prior to baseline and during the trial




18 Years - 80 Years

Accepts Healthy Volunteers



Bettina Wabbels, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID

MRZ 60201-0703/1

Secondary IDs


Responsible Party


Study Sponsor

Merz Pharmaceuticals GmbH

Study Sponsor

Bettina Wabbels, MD, Principal Investigator, Universitaets Augenklinik Bonn

Verification Date

February 2012