NCT00507637

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

July 25, 2007

Last Update Submit

February 3, 2012

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Change in Jankovic Rating Scale (JRS) score from baseline over time.

    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

    Week 6 up to week 62

Study Arms (1)

NT 201 (IncobotulinumtoxinA/Xeomin®)

EXPERIMENTAL
Drug: NT 201

Interventions

NT 201DRUG

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

Also known as: Xeomin®, IncobotulinumtoxinA, "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"
NT 201 (IncobotulinumtoxinA/Xeomin®)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaets Augenklinik

Bonn, 53125, Germany

Location

MeSH Terms

Conditions

Blepharospasm

Interventions

incobotulinumtoxinABotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Bettina Wabbels, MD

    Universitaets Augenklinik Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

DE(1)