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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00761592

Enrollment

Registered

2008-09-29

Start date

2006-07-31

Completion date

2008-01-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharospasm

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.

Interventions

BIOLOGICALBotulinum Toxin Type A 900kDa

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

BIOLOGICALBotulinum Toxin Type A 150kDa

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline to Week 4 in Blepharospasm Disability Index	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

Measure	Time frame	Description
Change From Baseline to Week 8 in Blepharospasm Disability Index	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)	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	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	Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)	Median Duration for decision to reinject

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Botulinum Toxin Type A 900kDa	31
Botulinum Toxin Type A 150kDa	33
Total	64

Baseline characteristics

Characteristic	Botulinum Toxin Type A 900kDa	Botulinum Toxin Type A 150kDa	Total
Age Continuous	70.7 years STANDARD_DEVIATION 10.7	67.1 years STANDARD_DEVIATION 12.1	68.8 years STANDARD_DEVIATION 11.5
Sex: Female, Male Female	20 Participants	19 Participants	39 Participants
Sex: Female, Male Male	11 Participants	14 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	21 / —	24 / —
serious Total, serious adverse events	1 / —	1 / —

Outcome results

Primary

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