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Completed

NCT Number: NCT00761592

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

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.

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Key information

Conditions

Blepharospasm Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bonn, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Botulinum Toxin Type A 900kDa

Biological

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

Other names: BOTOX®

Botulinum Toxin Type A 150kDa

Biological

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

Other names: Xeomin®

Primary outcomes

  1. Change From Baseline to Week 4 in Blepharospasm Disability Index

    Time frame: Baseline to Week 4

    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.

Secondary outcomes

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

    Time frame: Baseline to Week 8

    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.

  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)

    Time frame: Baseline to Week 4 and Week 8

    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.

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

    Time frame: Baseline to Week 4 and 8

    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.

  4. Duration of Action

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

    Median Duration for decision to reinject

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2008
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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