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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

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.

Condition or disease Intervention/treatment Phase
Blepharospasm Drug: NT 201 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: NT 201 (IncobotulinumtoxinA/Xeomin®) 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"

Primary Outcome Measures :
  1. 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".

Secondary Outcome Measures :
  1. 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).

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507637

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Universitaets Augenklinik
Bonn, Germany, 53125
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
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Principal Investigator: Bettina Wabbels, MD Universitaets Augenklinik Bonn
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Responsible Party: Merz Pharmaceuticals GmbH Identifier: NCT00507637    
Other Study ID Numbers: MRZ 60201-0703/1
2007-000697-23 ( EudraCT Number )
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents