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Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

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ClinicalTrials.gov Identifier: NCT01833130
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Migraine
Interventions Biological: OnabotulinumtoxinA
Drug: Normal saline (placebo)
Enrollment 52
Recruitment Details The Safety Population includes all 52 patients who received at least one injection with the study treatment. The Intent-to-Treat (ITT) population consists of all 45 randomized patients. Seven (7) patients were excluded from the ITT population as they were withdrawn from the study due to a randomization error.
Pre-assignment Details  
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Period Title: Overall Study
Started 25 27
Completed 15 8
Not Completed 10 19
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline) Total
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. Total of all reporting groups
Overall Number of Baseline Participants 19 26 45
Hide Baseline Analysis Population Description
Intent-to-Treat Population: all randomized patients (7 patients were withdrawn from the study due to a randomization error and excluded from the Intent-to-Treat population)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 26 participants 45 participants
43.7  (13.1) 42.2  (11.8) 42.8  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 26 participants 45 participants
Female
16
  84.2%
23
  88.5%
39
  86.7%
Male
3
  15.8%
3
  11.5%
6
  13.3%
1.Primary Outcome
Title Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 50.5  (17.6) 47.2  (22)
Change from Baseline at Week 24 (N=15, 18) -25.2  (23.5) -20.5  (24.6)
2.Secondary Outcome
Title Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
Hide Description The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 54.3  (22.1) 45.9  (25.9)
Change from Baseline at Week 24 (N=14, 18) -18.5  (39.2) -17.5  (30.1)
3.Secondary Outcome
Title Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire
Hide Description The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 8.4  (2.6) 8.2  (3.3)
Change from Baseline at Week 24 (N=14, 18) -1.6  (5.4) -1.9  (5.1)
4.Secondary Outcome
Title Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 45  (16.6) 43.3  (21.1)
Change from Baseline at Week 12 (N=15, 19) -15.7  (24.7) -15.3  (21.4)
Change from Baseline at Week 22 (N=13, 15) -30.4  (19.1) -18.7  (24.4)
Change from Baseline at Week 24 (N=15, 18) -24  (24.8) -21.9  (24.8)
5.Secondary Outcome
Title Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 51.9  (23.1) 42.3  (25.4)
Change from Baseline at Week 12 (N=15, 19) -20  (32) -13.9  (20.8)
Change from Baseline at Week 22 (N=13, 15) -26.7  (33.3) -14.9  (26.6)
Change from Baseline at Week 24 (N=15, 18) -26.2  (28.4) -16.3  (21)
6.Secondary Outcome
Title Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 47.9  (23.2) 43.1  (26.9)
Change from Baseline at Week 12 (N=15, 19) -16.7  (36.4) -20.5  (29.1)
Change from Baseline at Week 22 (N=13, 15) -32.3  (28.0) -16  (40.7)
Change from Baseline at Week 24 (N=15, 18) -30  (28.0) -18.9  (33.1)
7.Secondary Outcome
Title Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 39.6  (22.8) 43.1  (26.3)
Change from Baseline at Week 12 (N=15, 19) -9.8  (25.7) -21.8  (24.8)
Change from Baseline at Week 22 (N=13, 15) -19  (26.5) -20  (28.4)
Change from Baseline at Week 24 (N=15, 18) -18.7  (25.5) -19.6  (29.3)
8.Secondary Outcome
Title Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 51.6  (21.4) 55.4  (31.1)
Change from Baseline at Week 12 (N=15, 19) -16  (33.1) -25.3  (27.4)
Change from Baseline at Week 22 (N=13, 15) -29.2  (24) -22.7  (38.4)
Change from Baseline at Week 24 (N=15, 18) -26.7  (24.7) -30.0  (37.7)
9.Secondary Outcome
Title Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 45.3  (19.8) 48.5  (23.4)
Change from Baseline at Week 12 (N=15, 19) -17.3  (30.1) -18.9  (26.2)
Change from Baseline at Week 22 (N=13, 15) -27.7  (25.2) -24  (34)
Change from Baseline at Week 24 (N=15, 18) -24  (28.5) -24.4  (29.6)
10.Secondary Outcome
Title Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 58.2  (22.2) 60.2  (19.9)
Change from Baseline at Week 12 (N=15, 19) -19.7  (34.2) -22.4  (24.1)
Change from Baseline at Week 22 (N=13, 15) -33.1  (30.3) -20  (31.8)
Change from Baseline at Week 24 (N=15, 18) -26.3  (27.3) -23.3  (27.8)
11.Secondary Outcome
Title Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 18 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 60.0  (19.9) 52.6  (27.0)
Change from Baseline at Week 12 (N=15, 19) -25.2  (29.8) -20.7  (25.5)
Change from Baseline at Week 22 (N=13, 15) -31.1  (30.3) -20.9  (32.8)
Change from Baseline at Week 24 (N=14, 18) -31.8  (29.3) -26.3  (27.3)
12.Secondary Outcome
Title Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire
Hide Description The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.
Time Frame Baseline, Week 12, Week 22, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 57.9  (23) 53.1  (29.9)
Change from Baseline at Week 12 (N=15, 19) -22.7  (36.1) -18.9  (25.4)
Change from Baseline at Week 22 (N=12, 15) -38.3  (31.3) -10.7  (39.2)
Change from Baseline at Week 24 (N=14, 18) -28.6  (31.1) -15.6  (45.3)
13.Secondary Outcome
Title Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score
Hide Description The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 64.7  (4.2) 65.3  (5.5)
Change from Baseline at Week 24 (N=15, 18) -5.1  (4.7) -6.7  (7.9)
14.Secondary Outcome
Title Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)
Hide Description The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 39.8  (16.6) 40.9  (21.7)
Change from Baseline at Week 24 (N=13, 18) 32.1  (15.4) 26.5  (28.9)
15.Secondary Outcome
Title Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ
Hide Description The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 58.9  (18.8) 62.5  (23.0)
Change from Baseline at Week 24 (N=13, 18) 25.8  (18) 20.8  (28.9)
16.Secondary Outcome
Title Change From Baseline in the Emotional Function (EF) Domain of the MSQ
Hide Description The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Number of Participants Analyzed 19 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 53.3  (27.6) 58.7  (23.9)
Change from Baseline at Week 24 (N=14, 18) 26.2  (26.3) 18.5  (34.2)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.
 
Arm/Group Title OnabotulinumtoxinA Placebo (Normal Saline)
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
All-Cause Mortality
OnabotulinumtoxinA Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OnabotulinumtoxinA Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   1/27 (3.70%) 
Nervous system disorders     
Cerebrovascular Accident   0/25 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OnabotulinumtoxinA Placebo (Normal Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/25 (36.00%)   2/27 (7.41%) 
General disorders     
Injection Site Pain *  2/25 (8.00%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders     
Neck Pain *  4/25 (16.00%)  1/27 (3.70%) 
Shoulder Pain *  3/25 (12.00%)  0/27 (0.00%) 
Nervous system disorders     
Facial Paresis *  2/25 (8.00%)  0/27 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Medical Director,
Organization: Allergan, Inc
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01833130     History of Changes
Other Study ID Numbers: GMA-BTX-CM-12-545
First Submitted: April 12, 2013
First Posted: April 16, 2013
Results First Submitted: September 18, 2015
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015