Clinical Trial: Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Change From Baseline to Week 4 in Blepharospasm Disability Index [ Time Frame: Baseline to Week 4 ]

Original Primary Outcome: Change from baseline in Blepharospasm Disability Index [ Time Frame: Week 4 ]

Current Secondary Outcome:

• 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.

• 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.
• 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.

• 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

Original Secondary Outcome:

• Change from baseline in Blepharospasm Disability Index [ Time Frame: Week 8 ]
• Changes from baseline in total Jankovic Rating Scale [ Time Frame: Week 4, 8 ]
• Changes from baseline in Patient Global Assessment score [ Time Frame: Week 4, 8 ]
• Duration of Action [ Time Frame: Interval between initial injection and final visit ]
• Adverse Events [ Time Frame: Injection to Week 4 ]

Dates:
Date Received: September 25, 2008
Date Started: July 2006
Date Completion:
Last Updated: October 25, 2013
Last Verified: October 2013