Blepharospasm Short Interval

Phase 2TerminatedNCT00507637

Merz Pharmaceuticals GmbH8 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Blepharospasm

Interventions

NT 201DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitaets Augenklinik

Bonn, Germany

Outcomes

Primary Outcomes

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".

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.

Secondary Outcomes

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).

Time frame: From baseline up to week 62

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).

Time frame: Week 6 up to week 62

Data from ClinicalTrials.gov

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