Blepharospasm Short Interval

Blepharospasm Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00507637
• Other study ID #: MRZ 60201-0703/1
• Secondary ID: 2007-000697-23
• Status: Terminated
• Phase: Phase 2
• First received: July 25, 2007
• Last updated: February 3, 2012
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: February 2012
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm

Intervention

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

Locations

Country	Name	City	State
Germany	Universitaets Augenklinik	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between the actual Blepharospasm Disability Index [BSDI] value at each follow up visit and the BSDI value at baseline.	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".	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.	No
Secondary	Change in Jankovic Rating Scale (JRS) score from baseline over time.	The JRS ranges from 0-8 points and consists of the two items "Severity" and "Frequency" with five rating categories each (0-4 points).	From baseline up to week 62	No
Secondary	Patient Evaluation of Global Response [PEGR] rated by patient at visits V2 to V8 and at follow-up visit	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).	Week 6 up to week 62	No