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CompletedNCT00761592Updated Nov 19, 2013Results posted

Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

A Phase 4 interventional study of Botulinum Toxin Type A 900kDa and Botulinum Toxin Type A 150kDa in Blepharospasm, sponsored by Allergan. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.

Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Blepharospasm

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03

In context

Blepharospasm

42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.

This study's enrollment of 65 is above the median of 40 across 28 interventional studies indexed under Blepharospasm.

Browse Blepharospasm studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing .
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    1

    Biological: Botulinum Toxin Type A 900kDa

  • Active comparator
    2

    Biological: Botulinum Toxin Type A 150kDa

Interventions

  • BiologicalBotulinum Toxin Type A 900kDa

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

    Also known as: BOTOX®

  • BiologicalBotulinum Toxin Type A 150kDa

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

    Also known as: Xeomin®

06

What researchers measure

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.

    Time frame: Baseline to Week 4

Secondary outcomes

  1. Change From Baseline to Week 8 in Blepharospasm Disability Index

    Blepharospasm Disability Index is a validated 5-point (0-4) scale 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.

    Time frame: Baseline to Week 8

  2. 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)

    Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open \> 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.

    Time frame: Baseline to Week 4 and Week 8

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

    Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect +1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement.

    Time frame: Baseline to Week 4 and 8

  4. Duration of Action

    Median Duration for decision to reinject

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

07

Results

Posted Jul 9, 2009
Limitations and caveats
This was a pilot study.

Participant flow

Participant flow — Overall Study
MilestoneBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Started3233
Completed3132
Not completed11

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to Week 4
Reported as:
Mean · Points on Scale
Change From Baseline to Week 4 in Blepharospasm Disability Index
Points on ScaleBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Change From Baseline to Week 4 in Blepharospasm Disability Index-2.8 ± 5.3-1.3 ± 3.7
SecondaryChange From Baseline to Week 8 in Blepharospasm Disability Index

Blepharospasm Disability Index is a validated 5-point (0-4) scale 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.

Time frame:
Baseline to Week 8
Reported as:
Mean · Points on Scale
Change From Baseline to Week 8 in Blepharospasm Disability Index
Points on ScaleBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Change From Baseline to Week 8 in Blepharospasm Disability Index-1.3 ± 3.9-0.8 ± 3.2
SecondaryChange From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)

Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open \> 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.

Time frame:
Baseline to Week 4 and Week 8
Reported as:
Mean · Points on Scale
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)
Points on ScaleBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Change in JRS in Left Eye at Week 4-2.3 ± 1.5-1.5 ± 1.5
Change in JRS in Right Eye at Week 4-2.2 ± 1.5-1.5 ± 1.5
Change in JRS in Left Eye at Week 8-1.9 ± 1.7-1.3 ± 1.3
Change in JRS in Right Eye at Week 8-1.8 ± 1.7-1.3 ± 1.4
SecondaryChanges From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score

Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect +1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement.

Time frame:
Baseline to Week 4 and 8
Reported as:
Mean · Points on Scale
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Points on ScaleBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Change in PGA at Week 41.13 ± 1.860.52 ± 2.14
Change in PGA at Week 8-0.16 ± 2.370.19 ± 1.86
SecondaryDuration of Action

Median Duration for decision to reinject

Time frame:
Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)
Reported as:
Median · Weeks
Duration of Action
WeeksBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Duration of Action13.1 ± 2.013.1 ± 3.0

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Botulinum Toxin Type A 900kDa———
Botulinum Toxin Type A 150kDa———
Most frequent serious events
Most frequent serious events
EventBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Angioneurotic oedemaSkin and subcutaneous tissue disorders1/310/33
Carotid Artery StenosisNervous system disorders0/311/33
Most frequent other events
Showing 10 of 20
Most frequent other events
EventBotulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDa
Periorbital haematomaInjury, poisoning and procedural complications7/319/33
Eyelid ptosisEye disorders4/311/33
HeadacheNervous system disorders3/313/33
Sicca SyndromeEye disorders0/312/33
DiplopiaEye disorders1/310/33
Lacrimation increasedEye disorders1/310/33
Dry MouthGastrointestinal disorders1/310/33
Muscle SpasmsMusculoskeletal and connective tissue disorders1/310/33
Muscular WeaknessMusculoskeletal and connective tissue disorders1/310/33
NervousnessPsychiatric disorders1/310/33

Baseline characteristics

Age Continuous
Age Continuous(years)Botulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDaTotal
Mean70.7 ± 10.767.1 ± 12.168.8 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Botulinum Toxin Type A 900kDaBotulinum Toxin Type A 150kDaTotal
Female201939
Male111425
08

Study locations

3 sites
  • Bonn, Germany
  • Wiesbaden, Germany
  • Zwickau, Germany
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2006, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2009, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2008
First posted
Sep 29, 2008
Start
Jul 2006
Primary completionActual
Jan 2008
CompletionActual
Jan 2008
Results first posted
Jul 9, 2009
Last update
Nov 19, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00761592
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 29, 2008
Start date
Jul 2006
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Jul 9, 2009
Last update
Nov 19, 2013

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Onabotulinum toxin A · Botulinum toxin type A

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