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This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Experimental | 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) | Placebo Comparator | Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Biological | OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score | 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. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA | 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. |
| FG001 | Placebo (Normal Saline) | Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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)
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| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA | 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. |
| BG001 | Placebo (Normal Saline) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OnabotulinumtoxinA | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, | Allergan, Inc | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Normal saline (placebo) | Drug | Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. |
|
| Baseline, Week 24 |
| Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire | 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. | Baseline, Week 24 |
| Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 |
| Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score | 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. | Baseline, Week 24 |
| Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) | 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. | Baseline, Week 24 |
| Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ | 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. | Baseline, Week 24 |
| Change From Baseline in the Emotional Function (EF) Domain of the MSQ | 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. | Baseline, Week 24 |
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo (Normal Saline) |
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. |
|
|
| Secondary | Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12, Week 22, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in the Emotional Function (EF) Domain of the MSQ | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 24 |
|
|
|
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | Placebo (Normal Saline) | Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. | 1 | 27 | 2 | 27 |
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Facial Paresis | Nervous system disorders | Non-systematic Assessment |
|
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.
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=15, 18) |
|
| Change from Baseline at Week 22 (N=13, 15) |
|
| Change from Baseline at Week 24 (N=14, 18) |
|
| Change from Baseline at Week 22 (N=12, 15) |
|
| Change from Baseline at Week 24 (N=14, 18) |
|