Blepharospasm Short Interval

NCT ID: NCT00507637

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-02-29

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.

Conditions

Blepharospasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NT 201 (IncobotulinumtoxinA/Xeomin®)

Group Type: EXPERIMENTAL

NT 201

Intervention Type: DRUG

Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).

Interventions

NT 201

Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).

Intervention Type: DRUG

Other Intervention Names

Xeomin®; IncobotulinumtoxinA; "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Wabbels, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaets Augenklinik Bonn

Locations

Universitaets Augenklinik

Bonn, , Germany

Countries

Germany

Other Identifiers

2007-000697-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 60201-0703/1

Identifier Type: -

Identifier Source: org_study_id