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

Interventional


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.

Condition

Blepharospasm

Intervention

NT 201

Study Arms / Comparison Groups

 NT 201 (IncobotulinumtoxinA/Xeomin®)
Description:  

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

8

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Bettina Wabbels, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00507637

Organization ID

MRZ 60201-0703/1

Secondary IDs

2007-000697-23

Responsible Party

Sponsor

Study Sponsor

Merz Pharmaceuticals GmbH


Study Sponsor

Bettina Wabbels, MD, Principal Investigator, Universitaets Augenklinik Bonn


Verification Date

February 2012