NCT00406367

Brief Summary

Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2006

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 16, 2010

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

November 30, 2006

Results QC Date

August 31, 2010

Last Update Submit

March 13, 2013

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

  • Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)

    The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

    Baseline, week 6

Secondary Outcomes (3)

  • Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)

    Baseline, week 6

  • Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection

    Baseline, week 6

  • Patient Evaluation of Global Response (PEGR) at Final Visit

    Final visit (up to week 20 after injection of the Main Period)

Study Arms (2)

incobotulinumtoxinA (Xeomin)

EXPERIMENTAL

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection

Drug: incobotulinumtoxinA (Xeomin)

Placebo

PLACEBO COMPARATOR

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection

Drug: Placebo

Interventions

incobotulinumtoxinA (Xeomin)DRUG

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection

incobotulinumtoxinA (Xeomin)
PlaceboDRUG

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female pretreated outpatients between ages 18 and 80 years (inclusive)
  • A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
  • A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore \>= 2)
  • On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
  • Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry
  • At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline

You may not qualify if:

  • Atypical variant of BEB caused by inhibition of levator palpebrae muscle
  • Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
  • The previous two injections with BOTOX® with more than 50 Units per eye
  • Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
  • Neuroleptic induced blepharospasm
  • Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
  • 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 (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

David King, MD - Private Practice

Halifax, Nova Scotia, B3J 3T1, Canada

Location

Related Publications (2)

  • Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm-a randomized trial. Mov Disord. 2011 Jul;26(8):1521-8. doi: 10.1002/mds.23658. Epub 2011 Apr 22.

    PMID: 21520284RESULT

  • Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.

    PMID: 23435927RESULT

MeSH Terms

Conditions

Blepharospasm

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Results Point of Contact

Title
Angelika Hanschmann
Organization
Merz Pharmaceuticals GmbH
angelika.hanschmann@merz.de
++49-69-1503

Study Officials

  • Joseph Jankovic, Prof.

    Houston, Texas

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2008

Study Completion

July 1, 2009

Last Updated

March 15, 2013

Results First Posted

November 16, 2010

Record last verified: 2013-03

Locations

CA(1)US(1)