Trial Outcomes & Findings for Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm (NCT NCT00761592)
NCT ID: NCT00761592
Last Updated: 2013-11-19
Results Overview
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.
COMPLETED
PHASE4
65 participants
Baseline to Week 4
2013-11-19
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A 900kDa
|
Botulinum Toxin Type A 150kDa
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Intention to Treat
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
|---|---|---|
|
Change From Baseline to Week 4 in Blepharospasm Disability Index
|
-2.8 Points on Scale
Standard Deviation 5.3
|
-1.3 Points on Scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intention to Treat
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
|---|---|---|
|
Change From Baseline to Week 8 in Blepharospasm Disability Index
|
-1.3 Points on Scale
Standard Deviation 3.9
|
-0.8 Points on Scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 8Population: Intention to Treat
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
|---|---|---|
|
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)
Change in JRS in Left Eye at Week 4
|
-2.3 Points on Scale
Standard Deviation 1.5
|
-1.5 Points on Scale
Standard Deviation 1.5
|
|
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)
Change in JRS in Right Eye at Week 4
|
-2.2 Points on Scale
Standard Deviation 1.5
|
-1.5 Points on Scale
Standard Deviation 1.5
|
|
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)
Change in JRS in Left Eye at Week 8
|
-1.9 Points on Scale
Standard Deviation 1.7
|
-1.3 Points on Scale
Standard Deviation 1.3
|
|
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)
Change in JRS in Right Eye at Week 8
|
-1.8 Points on Scale
Standard Deviation 1.7
|
-1.3 Points on Scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and 8Population: Intention to Treat
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
|---|---|---|
|
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Change in PGA at Week 4
|
1.13 Points on Scale
Standard Deviation 1.86
|
0.52 Points on Scale
Standard Deviation 2.14
|
|
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Change in PGA at Week 8
|
-0.16 Points on Scale
Standard Deviation 2.37
|
0.19 Points on Scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)Population: Intention to Treat
Median Duration for decision to reinject
Outcome measures
| Measure |
Botulinum Toxin Type A 900kDa
n=31 Participants
|
Botulinum Toxin Type A 150kDa
n=33 Participants
|
|---|---|---|
|
Duration of Action
|
13.1 Weeks
Standard Deviation 2.0
|
13.1 Weeks
Standard Deviation 3.0
|
Adverse Events
Botulinum Toxin Type A 900kDa
Botulinum Toxin Type A 150kDa
Serious adverse events
| Measure |
Botulinum Toxin Type A 900kDa
|
Botulinum Toxin Type A 150kDa
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
3.2%
1/31
|
0.00%
0/33
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/31
|
3.0%
1/33
|
Other adverse events
| Measure |
Botulinum Toxin Type A 900kDa
|
Botulinum Toxin Type A 150kDa
|
|---|---|---|
|
Eye disorders
Diplopia
|
3.2%
1/31
|
0.00%
0/33
|
|
Eye disorders
Dry Eye
|
0.00%
0/31
|
3.0%
1/33
|
|
Eye disorders
Eye Swelling
|
0.00%
0/31
|
3.0%
1/33
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/31
|
3.0%
1/33
|
|
Eye disorders
Lacrimation increased
|
3.2%
1/31
|
0.00%
0/33
|
|
Eye disorders
Lid Lag
|
0.00%
0/31
|
3.0%
1/33
|
|
Eye disorders
Sicca Syndrome
|
0.00%
0/31
|
6.1%
2/33
|
|
Gastrointestinal disorders
Dry Mouth
|
3.2%
1/31
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/31
|
3.0%
1/33
|
|
Infections and infestations
Influenza
|
0.00%
0/31
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
22.6%
7/31
|
27.3%
9/33
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.2%
1/31
|
0.00%
0/33
|
|
Nervous system disorders
Headache
|
9.7%
3/31
|
9.1%
3/33
|
|
Nervous system disorders
Mastication Disorder
|
0.00%
0/31
|
3.0%
1/33
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31
|
3.0%
1/33
|
|
Psychiatric disorders
Nervousness
|
3.2%
1/31
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
1/31
|
0.00%
0/33
|
|
Eye disorders
Eyelid ptosis
|
12.9%
4/31
|
3.0%
1/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60