Blepharospasm Short Interval

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507637
Recruitment Status : Terminated (primary efficacy endpoint not attainable.)
First Posted : July 26, 2007
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

July 25, 2007
July 26, 2007
February 6, 2012
August 2007
February 2008   (Final data collection date for primary outcome measure)
The difference between the actual Blepharospasm Disability Index [BSDI] value at each follow up visit and the BSDI value at baseline. [ Time Frame: From baseline up to week 62. Follow up visits include 8 injection visits (V2 to V8) with intervals of at least 6 weeks between injections. ]
The BSDI includes 6 items to be assessed by a 5-point scoring (i.e., 0-4 points per item) ranging from "no impairment, "slight impairment", "moderate impairment", "severe impairment" to "no longer possible due to my illness". The 6 items are "Driving a vehicle", "Reading", "Watching TV", "Shopping", "Walking" and "Doing everyday activities".
Blepharospasm Disability Index [BSDI] measured at baseline visit before first injection, at each day of the following treatment visits before administration of NT 201, at the follow-up visit and at each telephone contact
Complete list of historical versions of study NCT00507637 on Archive Site
  • Change in Jankovic Rating Scale (JRS) score from baseline over time. [ Time Frame: From baseline up to week 62 ]
    The JRS ranges from 0-8 points and consists of the two items "Severity" and "Frequency" with five rating categories each (0-4 points).
  • Patient Evaluation of Global Response [PEGR] rated by patient at visits V2 to V8 and at follow-up visit [ Time Frame: Week 6 up to week 62 ]
    The PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from "complete abolishment of signs and symptoms" (+4) down to "very marked worsening" (-4).
- JRS sum score recorded at visit V1-V8, at visit V9, and at each telephone contact - Patient Evaluation of Global Response [PEGR] rated by patient at visits V2 to V8 and at follow-up visit
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Blepharospasm Short Interval
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
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: NT 201
Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).
Other Names:
  • Xeomin®
  • IncobotulinumtoxinA
  • "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"
Experimental: NT 201 (IncobotulinumtoxinA/Xeomin®)
Intervention: Drug: NT 201
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
MRZ 60201-0703/1
2007-000697-23 ( EudraCT Number )
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Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Principal Investigator: Bettina Wabbels, MD Universitaets Augenklinik Bonn
Merz Pharmaceuticals GmbH
February 2012

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