Trial Outcomes & Findings for Calcitonin Gene-related Peptide Levels in Chronic Migraine (NCT NCT01071096)
NCT ID: NCT01071096
Last Updated: 2013-02-12
Results Overview
Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Group A
Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
|
Group B
Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
|
|---|---|---|
|
First Intervention (90 Days)
STARTED
|
10
|
10
|
|
First Intervention (90 Days)
COMPLETED
|
9
|
10
|
|
First Intervention (90 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout Period (30 Days)
STARTED
|
9
|
10
|
|
Washout Period (30 Days)
COMPLETED
|
9
|
10
|
|
Washout Period (30 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (90 Days)
STARTED
|
9
|
10
|
|
Second Intervention (90 Days)
COMPLETED
|
9
|
10
|
|
Second Intervention (90 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A
Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
|
Group B
Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
|
|---|---|---|
|
First Intervention (90 Days)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Calcitonin Gene-related Peptide Levels in Chronic Migraine
Baseline characteristics by cohort
| Measure |
Enrolled Participants
n=20 Participants
Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
48.45 years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Outcome measures
| Measure |
Group A
n=9 Participants
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Group B
n=10 Participants
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Saline
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
|
Month 3 vs. Saline Non-Responders
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with \<30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \>30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Non-Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \<30% reduction in number of headache days per month from baseline.
|
|---|---|---|---|---|---|---|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 1
|
-7.61 days
Standard Deviation 8.01
|
-6.67 days
Standard Deviation 6.28
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 2
|
-9.72 days
Standard Deviation 5.96
|
-5.22 days
Standard Deviation 4.44
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 3
|
-10.06 days
Standard Deviation 5.92
|
-5.22 days
Standard Deviation 5.14
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 4
|
-9.50 days
Standard Deviation 8.34
|
-6.89 days
Standard Deviation 7.08
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 5
|
-8.94 days
Standard Deviation 8.15
|
-6.33 days
Standard Deviation 4.12
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 6
|
-9.50 days
Standard Deviation 7.93
|
-9.22 days
Standard Deviation 5.45
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Baseline vs. Month 7
|
-6.50 days
Standard Deviation 7.53
|
-4.56 days
Standard Deviation 6.89
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Outcome measures
| Measure |
Group A
n=9 Participants
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Group B
n=10 Participants
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Saline
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
|
Month 3 vs. Saline Non-Responders
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with \<30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \>30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Non-Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \<30% reduction in number of headache days per month from baseline.
|
|---|---|---|---|---|---|---|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 2 vs. Mo 3
|
-0.33 days
Standard Deviation 3.97
|
0.00 days
Standard Deviation 1.94
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Baseline vs. Mo 1
|
-7.61 days
Standard Deviation 8.01
|
-6.67 days
Standard Deviation 6.28
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 1 vs. Mo 2
|
-2.11 days
Standard Deviation 7.20
|
1.44 days
Standard Deviation 7.78
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 3 vs. Mo 4
|
0.56 days
Standard Deviation 3.91
|
-1.67 days
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 4 vs. Mo 5
|
0.56 days
Standard Deviation 3.21
|
0.56 days
Standard Deviation 4.61
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 5 vs. Mo 6
|
-0.56 days
Standard Deviation 3.84
|
-2.89 days
Standard Deviation 5.42
|
—
|
—
|
—
|
—
|
|
Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Mo 6 vs. M 7
|
3.00 days
Standard Deviation 3.84
|
4.67 days
Standard Deviation 5.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.
Outcome measures
| Measure |
Group A
n=19 Participants
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Group B
n=19 Participants
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Saline
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
|
Month 3 vs. Saline Non-Responders
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with \<30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \>30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Non-Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \<30% reduction in number of headache days per month from baseline.
|
|---|---|---|---|---|---|---|
|
Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)
Treatment Month 1
|
39.64 pmol/mg total protein
Standard Error 7.5
|
40.79 pmol/mg total protein
Standard Error 9.73
|
—
|
—
|
—
|
—
|
|
Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)
Treatment Month 2
|
28.37 pmol/mg total protein
Standard Error 7.07
|
39.14 pmol/mg total protein
Standard Error 9.74
|
—
|
—
|
—
|
—
|
|
Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)
Treatment Month 3
|
26.14 pmol/mg total protein
Standard Error 3.93
|
50.63 pmol/mg total protein
Standard Error 15.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.
Outcome measures
| Measure |
Group A
n=10 Participants
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Group B
n=9 Participants
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Saline
n=19 Participants
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
|
Month 3 vs. Saline Non-Responders
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with \<30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \>30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Non-Responders
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \<30% reduction in number of headache days per month from baseline.
|
|---|---|---|---|---|---|---|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 3 - Attack
|
73.18 pmol/mg total protein
Standard Deviation 58.88
|
30.17 pmol/mg total protein
Standard Deviation 38.63
|
46.16 pmol/mg total protein
Standard Deviation 40.29
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 1 - Baseline
|
52.36 pmol/mg total protein
Standard Deviation 56.31
|
29.36 pmol/mg total protein
Standard Deviation 32.81
|
70.46 pmol/mg total protein
Standard Deviation 98.26
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 1 - Attack
|
27.94 pmol/mg total protein
Standard Deviation 21.85
|
22.36 pmol/mg total protein
Standard Deviation 20.38
|
36.23 pmol/mg total protein
Standard Deviation 33.16
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 1 - 2 Hours Post
|
61.55 pmol/mg total protein
Standard Deviation 44.82
|
23.66 pmol/mg total protein
Standard Deviation 12.11
|
39.76 pmol/mg total protein
Standard Deviation 54.51
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 2 - Baseline
|
59.89 pmol/mg total protein
Standard Deviation 49.27
|
28.66 pmol/mg total protein
Standard Deviation 20.59
|
44.12 pmol/mg total protein
Standard Deviation 49.70
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 2 - Attack
|
60.14 pmol/mg total protein
Standard Deviation 51.18
|
32.65 pmol/mg total protein
Standard Deviation 33.80
|
33.05 pmol/mg total protein
Standard Deviation 30.96
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 2 - 2 Hours Post
|
39.13 pmol/mg total protein
Standard Deviation 60.98
|
22.35 pmol/mg total protein
Standard Deviation 19.94
|
33.93 pmol/mg total protein
Standard Deviation 35.91
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 3 - Baseline
|
51.33 pmol/mg total protein
Standard Deviation 77.44
|
32.61 pmol/mg total protein
Standard Deviation 40.13
|
58.74 pmol/mg total protein
Standard Deviation 53.86
|
—
|
—
|
—
|
|
Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Treatment Month 3 - 2 Hours Post
|
54.04 pmol/mg total protein
Standard Deviation 34.77
|
19.11 pmol/mg total protein
Standard Deviation 13.24
|
49.39 pmol/mg total protein
Standard Deviation 43.81
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapyPopulation: Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.
Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, \& 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)
Outcome measures
| Measure |
Group A
n=5 Participants
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Group B
n=5 Participants
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
|
Saline
n=5 Participants
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
|
Month 3 vs. Saline Non-Responders
n=5 Participants
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with \<30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Responders
n=5 Participants
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \>30% reduction in number of headache days per month from baseline.
|
Month 1 vs. Month 3 Non-Responders
n=5 Participants
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with \<30% reduction in number of headache days per month from baseline.
|
|---|---|---|---|---|---|---|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-17E
|
0.86 Florescent Units (FU)
Standard Deviation 0.50
|
1.02 Florescent Units (FU)
Standard Deviation 0.91
|
1.59 Florescent Units (FU)
Standard Deviation 1.79
|
0.42 Florescent Units (FU)
Standard Deviation 0.13
|
1.28 Florescent Units (FU)
Standard Deviation 0.85
|
1.45 Florescent Units (FU)
Standard Deviation 0.04
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-23
|
2.45 Florescent Units (FU)
Standard Deviation 1.85
|
1.80 Florescent Units (FU)
Standard Deviation 1.55
|
1.06 Florescent Units (FU)
Standard Deviation 0.12
|
1.69 Florescent Units (FU)
Standard Deviation 1.54
|
0.93 Florescent Units (FU)
Standard Deviation 0.01
|
2.61 Florescent Units (FU)
Standard Deviation 3.34
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IP-10
|
1.32 Florescent Units (FU)
Standard Deviation 1.05
|
0.95 Florescent Units (FU)
Standard Deviation 0.17
|
0.86 Florescent Units (FU)
Standard Deviation 0.52
|
2.76 Florescent Units (FU)
Standard Deviation 2.23
|
1.55 Florescent Units (FU)
Standard Deviation 1.50
|
3.11 Florescent Units (FU)
Standard Deviation 2.69
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
I-TAC
|
1.40 Florescent Units (FU)
Standard Deviation 0.78
|
0.28 Florescent Units (FU)
Standard Deviation 0.12
|
1.01 Florescent Units (FU)
Standard Deviation 0.89
|
0.94 Florescent Units (FU)
Standard Deviation 0.26
|
0.67 Florescent Units (FU)
Standard Deviation 0.27
|
3.65 Florescent Units (FU)
Standard Deviation 1.33
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
MIF
|
3.71 Florescent Units (FU)
Standard Deviation 6.25
|
9.55 Florescent Units (FU)
Standard Deviation 19.47
|
2.71 Florescent Units (FU)
Standard Deviation 4.50
|
8.66 Florescent Units (FU)
Standard Deviation 16.79
|
0.80 Florescent Units (FU)
Standard Deviation 0.32
|
1.24 Florescent Units (FU)
Standard Deviation 0.27
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
Serpin E1
|
0.98 Florescent Units (FU)
Standard Deviation 0.17
|
0.70 Florescent Units (FU)
Standard Deviation 0.53
|
0.70 Florescent Units (FU)
Standard Deviation 0.33
|
0.90 Florescent Units (FU)
Standard Deviation 0.82
|
0.76 Florescent Units (FU)
Standard Deviation 0.39
|
3.16 Florescent Units (FU)
Standard Deviation 3.25
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
RANTES
|
0.95 Florescent Units (FU)
Standard Deviation 0.41
|
0.77 Florescent Units (FU)
Standard Deviation 0.28
|
0.93 Florescent Units (FU)
Standard Deviation 0.41
|
0.91 Florescent Units (FU)
Standard Deviation 0.27
|
1.14 Florescent Units (FU)
Standard Deviation 0.21
|
1.24 Florescent Units (FU)
Standard Deviation 0.26
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
C5/C5a
|
1.38 Florescent Units (FU)
Standard Deviation 0.23
|
1.01 Florescent Units (FU)
Standard Deviation 0.90
|
1.39 Florescent Units (FU)
Standard Deviation 0.80
|
1.61 Florescent Units (FU)
Standard Deviation 0.54
|
1.03 Florescent Units (FU)
Standard Deviation 0.57
|
3.26 Florescent Units (FU)
Standard Deviation 3.35
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
CD40 Ligand
|
1.09 Florescent Units (FU)
Standard Deviation 0.25
|
1.26 Florescent Units (FU)
Standard Deviation 0.99
|
0.98 Florescent Units (FU)
Standard Deviation 0.37
|
1.31 Florescent Units (FU)
Standard Deviation 0.63
|
0.91 Florescent Units (FU)
Standard Deviation 0.27
|
1.22 Florescent Units (FU)
Standard Deviation 0.40
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
G-CSF
|
0.92 Florescent Units (FU)
Standard Deviation 0.45
|
0.93 Florescent Units (FU)
Standard Deviation 0.55
|
0.85 Florescent Units (FU)
Standard Deviation 0.24
|
0.99 Florescent Units (FU)
Standard Deviation 0.58
|
1.07 Florescent Units (FU)
Standard Deviation 0.74
|
1.34 Florescent Units (FU)
Standard Deviation 0.76
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
GROa
|
1.34 Florescent Units (FU)
Standard Deviation 1.56
|
3.18 Florescent Units (FU)
Standard Deviation 2.20
|
1.40 Florescent Units (FU)
Standard Deviation 1.33
|
1.81 Florescent Units (FU)
Standard Deviation 1.32
|
1.05 Florescent Units (FU)
Standard Deviation 0.96
|
0.73 Florescent Units (FU)
Standard Deviation 0.55
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
sICAM-1
|
2.60 Florescent Units (FU)
Standard Deviation 2.32
|
0.61 Florescent Units (FU)
Standard Deviation 0.54
|
5.99 Florescent Units (FU)
Standard Deviation 6.13
|
2.00 Florescent Units (FU)
Standard Deviation 1.98
|
3.99 Florescent Units (FU)
Standard Deviation 3.22
|
1.51 Florescent Units (FU)
Standard Deviation 0.15
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IFN-y
|
1.29 Florescent Units (FU)
Standard Deviation 0.34
|
0.80 Florescent Units (FU)
Standard Deviation 0.69
|
1.29 Florescent Units (FU)
Standard Deviation 0.82
|
1.92 Florescent Units (FU)
Standard Deviation 2.95
|
0.91 Florescent Units (FU)
Standard Deviation 0.34
|
1.63 Florescent Units (FU)
Standard Deviation 0.94
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-1alpha
|
2.30 Florescent Units (FU)
Standard Deviation 1.86
|
2.88 Florescent Units (FU)
Standard Deviation 4.29
|
1.50 Florescent Units (FU)
Standard Deviation 0.92
|
2.14 Florescent Units (FU)
Standard Deviation 3.04
|
0.86 Florescent Units (FU)
Standard Deviation 0.60
|
0.81 Florescent Units (FU)
Standard Deviation 0.32
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-1beta
|
1.63 Florescent Units (FU)
Standard Deviation 0.80
|
1.12 Florescent Units (FU)
Standard Deviation 1.09
|
1.38 Florescent Units (FU)
Standard Deviation 1.15
|
0.51 Florescent Units (FU)
Standard Deviation 0.23
|
1.15 Florescent Units (FU)
Standard Deviation 0.12
|
1.03 Florescent Units (FU)
Standard Deviation 0.43
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-1ra
|
1.13 Florescent Units (FU)
Standard Deviation 0.56
|
2.02 Florescent Units (FU)
Standard Deviation 2.66
|
0.96 Florescent Units (FU)
Standard Deviation 0.39
|
1.90 Florescent Units (FU)
Standard Deviation 1.58
|
0.88 Florescent Units (FU)
Standard Deviation 0.12
|
1.30 Florescent Units (FU)
Standard Deviation 0.43
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-8
|
1.61 Florescent Units (FU)
Standard Deviation 0.83
|
1.70 Florescent Units (FU)
Standard Deviation 2.03
|
2.71 Florescent Units (FU)
Standard Deviation 2.29
|
1.22 Florescent Units (FU)
Standard Deviation 1.24
|
4.38 Florescent Units (FU)
Standard Deviation 6.98
|
2.28 Florescent Units (FU)
Standard Deviation NA
Only one value available (2.28) so there is no standard deviation between reported values.
|
|
Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
IL-16
|
0.91 Florescent Units (FU)
Standard Deviation 0.63
|
2.07 Florescent Units (FU)
Standard Deviation 1.63
|
0.75 Florescent Units (FU)
Standard Deviation 0.48
|
1.97 Florescent Units (FU)
Standard Deviation 1.64
|
0.98 Florescent Units (FU)
Standard Deviation 0.66
|
1.10 Florescent Units (FU)
Standard Deviation 0.48
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
OnabotulinumtoxinA
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline
n=20 participants at risk
Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
|
OnabotulinumtoxinA
n=20 participants at risk
Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
1st Degree Burn on Extremity
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
2nd Degree Burn on Extremity
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chest Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Contusion of extremity
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Surgical and medical procedures
Dental Implant
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Elevated Cholesterol
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Enlarged Lymph Node
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Eyebrow Ptosis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Facial Edema
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Fibromyalgia Pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Head Pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Head Tenderness
|
0.00%
0/20
|
5.0%
1/20 • Number of events 2
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Heart Arrhythmia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Hoarseness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Influenza
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Inner Ear Fluid Imbalance
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/20
|
25.0%
5/20 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Oral Lesion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Otitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Paresthesia as Injection Site
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Parotid Glad Infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pharyngitis Streptococcal
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pharyngolaryngeal Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Congestion
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Surgical and medical procedures
Ruptured Breast Implant
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Gland Infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Gland Obstruction
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Scalp Pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
20.0%
4/20 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Stress
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Track Infection
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Vertigo
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place