NCT00761592

Brief Summary

This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

3 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

July 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 9, 2009

Completed
Last Updated

November 19, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

September 25, 2008

Results QC Date

January 30, 2009

Last Update Submit

October 25, 2013

Conditions

Blepharospasm

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 4 in Blepharospasm Disability Index

    Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.

    Baseline to Week 4

Secondary Outcomes (4)

  • Change From Baseline to Week 8 in Blepharospasm Disability Index

    Baseline to Week 8

  • Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)

    Baseline to Week 4 and Week 8

  • Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score

    Baseline to Week 4 and 8

  • Duration of Action

    Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)

Study Arms (2)

1

ACTIVE COMPARATOR
Biological: Botulinum Toxin Type A 900kDa

2

ACTIVE COMPARATOR
Biological: Botulinum Toxin Type A 150kDa

Interventions

Botulinum Toxin Type A 900kDaBIOLOGICAL

6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Also known as: BOTOX®
1
Botulinum Toxin Type A 150kDaBIOLOGICAL

6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Also known as: Xeomin®
2

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with benign essential blepharospasm
  • Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
  • Combined Jankovic Rating Score of \>2

You may not qualify if:

  • Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
  • Profound atrophy of the muscles in the target area(s) of injection.
  • Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
  • Known significantly impaired renal and/or hepatic function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Zwickau, Germany

Location

MeSH Terms

Conditions

Blepharospasm

Interventions

Botulinum Toxins, Type AincobotulinumtoxinA

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was a pilot study.

Results Point of Contact

Title
Vice President Medical Affairs
Organization
Allergan, Inc.
clinicaltrials@allergan.com
(714)246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

July 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 19, 2013

Results First Posted

July 9, 2009

Record last verified: 2013-10

Locations

DE(3)